Abstract: Platelets play a critical role in the pathogenesis of atherothrombotic processes and inhibition of platelet aggregation by antiplatelet therapy is essential and really important in the acute coronary syndromes or in the setting of percutaneous coronary intervention. The first family of adenosine diphosphate P2Y12 receptors inhibiting drug is represented by thienopyridines and among these ticlopidine was the first approved by Food and Drug Administration; actually its use is discouraged because of its potential side effects (neutropenia, anemia, gastrointestinal distress and thrombotic thrombocytopenic purpura). The second generation of thienopyridines is represented by clopidogrel that has replaced ticlopidine in the clinical practice; clopidogrel has the largest clinical experience. Prasugrel represents the third generation. It inhibits platelet aggregation by irreversibly blocking the adenosine diphosphate P2Y12 receptor. Ticagrelor, Cangrelor and Enilogrel represent the last generation of thienopyridines. This review is focused on the effects of adenosine diphosphate P2Y12 inhibitors.
Abstract: The aim of this study was to determine whether pre-procedural analysis of multidetector row computed tomography (MDCT) scans could accurately predict the "line of perpendicularity" (LP) of the aortic annulus and corresponding C-arm angulations required for prosthesis delivery and impact the outcome of the procedure.
Abstract: Atherosclerotic coronary plaques represent the main substrate for coronary artery disease (CAD), and changes in plaque volume, investigated with intravascular ultrasound (IVUS), have been used as surrogate end-points in several clinical trials. However, no conclusive data are available to support the exploitation of IVUS-based plaque changes as a measure of clinically meaningful treatment's effect.
Abstract: The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI).
Abstract: Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES.
Abstract: The percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents. Dedicated bifurcation stents could provide an attractive alternative to improve early outcomes and reduce SB restenosis. We aimed to assess in a prospective single-arm multicentre registry, safety and effectiveness at 6-month clinical follow-up of the Tryton dedicated side branch (SB) stent.
Abstract: To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this.
Abstract: Coronary trifurcation lesions are a complex subset of lesions. We present a case of a percutaneous intervention of a trifurcation lesion involving the left anterior descending artery and 2 diagonal branches completely treated with one single device, the novel stent-on-a-wire (SOAW) (Svelte Medical Systems), for the whole procedure. The SOAW is an all-in-one device with a bare cobalt-chrome stent mounted on a balloon directly connected to a wire. The stent of the SOAW was deployed in the left anterior descending artery over the ostia of the 2 diagonal branches. Using the same wire plus balloon device of the SOAW, further recrossing in direction of the 2 side branches and balloon dilation of both ostia through the stent struts was possible. Conclusive post-dilatation of the stent was then performed once again with the same SOAW device. The final angiographic result was successful, and patency of the stented segment was confirmed also at 5-month angiographic follow-up.
Abstract: After its first introduction in 2002, transcatheter aortic valve implantation (TAVI) has continuously gained more foothold for the treatment of severe aortic stenosis and is nowadays a viable treatment option for inoperable patients or patients at high risk for conventional surgical aortic valve replacement. Although ideally carried out in a so-called hybrid room, incorporating both the strict hygiene and advanced life support possibilities of the operating theatre and the imaging and percutaneous arsenal of the catheterisation suite, in most centres TAVI is at present performed in the catheterisation laboratory. This may raise concern about an increased risk of infection, since there the criteria that are applied regarding disinfection and sterilisation are not as stringent as those of the operating theatre. Therefore, we retrospectively assessed the number of infective complications in patients undergoing TAVI in the catheterisation lab of our institution. Eleven out of 73 patients developed a postprocedural infection, one of which could be attributed to the procedure itself, being superinfection of a surgical groin cut-down. Our conclusion is that percutaneous aortic valve implantation in a catheterisation laboratory is not associated with an increased risk of infective complications.
Abstract: The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access.
Abstract: The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions.
Abstract: Aortic dissection is an uncommon but potentially lethal complication that can occur during the engagement of a guiding catheter. We report a case of a 59-year-old woman with acute aortic dissection due to percutaneous coronary intervention. This resulted in a retrograde extension of the dissection into the proximal part of the ascending aorta. With haemodynamic stability, we decided to treat the aortic dissection medically. As a result, a complete resolution of the aortic dissection was documented by coronary angiography and the follow-up computed tomography scan.
Abstract: OBJECTIVES: To assess the incidence of silent cerebral embolization when using the transradial approach for diagnostic coronary angiography (DCA). BACKGROUND: Compared to other vascular access sites, the right transradial approach (RTA) could reduce the amount of brain emboli by avoiding mechanical trauma to the aortic wall caused by catheters and wire, whereas it increases manipulation of catheters in the ascending aorta and has a higher risk of direct embolization into the right common carotid artery. A recent study showed an increased incidence of microembolic signals (MES) in RTA compared to femoral. However, left transradial approach (LTA) has never been assessed. METHODS: 40 patients with suspected coronary artery disease were randomized to DCA via RTA (n=20) or LTA (n=20) with contemporaneous bilateral transcranial Doppler monitoring. RESULTS: MES were detected in all patients, with a significantly higher rate in the RTA group (median 61, interquartile range (IQR) 47-105, vs 48, IQR 31-60, p=0.035). MES generated during procedures needing >2 catheters (n=8), are higher than those detected during procedures performed with 2 catheters (n=32, 102, IQR 70-108, vs 48, IQR 33-60, p=0.001). At multivariate analysis increasing number of catheters was the only independent predictor of high incidence of MES (OR 16.4, 95% CI 1.23-219.9, p=0.034, -2LL=26.7). CONCLUSIONS: LTA has a lower risk of brain embolization because of the lower number of catheter exchange maneuvers. Since the degree of brain embolism depends on the magnitude of mechanical manipulation, catheter changes should be minimized to reduce the risk of cerebral embolization.
Abstract: Trans-radial and trans-ulnar access is increasingly used for percutaneous coronary procedures, but spasm or pain may limit comfort and compliance. Intra-arterial lidocaine administration could provide a local anaesthetic effect, but its risk-benefit ratio is unclear. We aimed to compare intraarterial lidocaine versus saline to reduce peri-procedural discomfort during percutaneous trans-radial or trans-ulnar procedures.
Abstract: Stem cell therapy is a treatment strategy for ischaemic heart disease patients. Meta-analysis of randomized human trials showed <5% improvement in left ventricular ejection fraction (LVEF). Meta-analysis of available pre-clinical data of ischaemic heart disease could provide important clues to design human clinical trials.
Abstract: In a subpopulation of patients with essential hypertension, therapeutic targets are not met, despite the use of multiple types of medication. In this paper we describe our first experience with a novel percutaneous treatment modality using renal artery radiofrequency (RF) ablation.
Abstract: Cardiopulmonary support including closed chest compression is a mainstay in the management of cardiac arrest. However, traditional means (i.e. manual) chest compression may be logistically challenging, especially in patients requiring emergent invasive procedures such as percutaneous coronary intervention for cardiac arrest due to acute myocardial infarction. The LUCAS mechanical chest compression device provides external and automated closed chest compression, thus enabling even complex invasive procedures without interrupting cardiopulmonary support. Nonetheless, no randomized trial has proved to date its benefit in comparison to standard manual chest compression, and to date only observational studies and consensus opinion support its clinical use.
Abstract: Clopidogrel is beneficial after ACS. Recent data suggest the superiority of prasugrel or ticagrelor compared with clopidogrel. However, there is no comparison of prasugrel vs. ticagrelor. We performed an adjusted indirect meta-analysis comparing prasugrel vs. ticagrelor for acute coronary syndromes (ACSs).
Abstract: To perform a systematic review and meta-analysis of studies reporting outcomes after drug-eluting stent (DES) implantation in chronic total occlusions (CTOs).
Abstract: Clinicians often face difficult decisions despite the lack of evidence from randomized trials. Thus, clinical evidence is often shaped by non-randomized studies exploiting multivariable approaches to limit the extent of confounding. Since their introduction, propensity scores have been used more and more frequently to estimate relevant clinical effects adjusting for established confounders, especially in small datasets. However, debate persists on their real usefulness in comparison to standard multivariable approaches such as logistic regression and Cox proportional hazard analysis. This holds even truer in light of key quantitative developments such as bootstrap and Bayesian methods. This qualitative review aims to provide a concise and practical guide to choose between propensity scores and standard multivariable analysis, emphasizing strengths and weaknesses of both approaches.
Abstract: A 67-year-old man underwent primary percutaneous coronary intervention for acute anterior ST elevation myocardial infarction. The right radial artery was the access of choice. After easy cannulation, a 360-degree loop was found at the elbow level. The brachial artery and a large ulnar artery were visible by injecting contrast through the radial loop. After an unsuccessful attempt to engage the loop, the operator switched entry site for the homolateral ulnar artery. Leaving the radial sheath in place, the cannulation of the ulnar artery was successful and uncomplicated. The operator could easily perform a successful intervention of the culprit vessel. An angiogram of the wrist, via the ulnar sheath showed the presence of a big interosseous artery with flow up to the hand and no flow in the radial and ulnar arteries distal to the sheaths. The ulnar and radial arteries were successfully sealed after a few hours, a valid pulsation was present on both arteries and no signs of ischemia were evident in the right hand the day after.
Abstract: To assess the safety and efficacy of the second generation DIOR paclitaxel drug-eluting balloon (DEB) for in-stent restenosis in a real world setting in a prospective single-arm registry with 8-month clinical outcomes.
Abstract: We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions.
Abstract: Coronary bifurcation lesions, which account for 15-20% of all lesions treated percutaneously, remain hampered by procedural difficulties, post-procedural complications and suboptimal long-term results, even with the introduction of the drug-eluting stent (DES). Side branch (SB) restenosis rates remain a drawback even in the provisional T-stenting technique with final kissing balloons. The introduction of drug-eluting balloons (DEB) creates a new hope for this technique by maintaining the relatively easy provisional T-technique but promising better long term outcomes for the SB treated with DEB. The DEB delivers locally a high concentration of an anti-restenotic drug, paclitaxel, thereby potentially reducing restenosis rates as compared to a regular balloon. However little is still known on the optimal use and long-term outcomes of DEB in bifurcations. First results of the DEBIUT study will help to understand future directions in development of this new and promising device.
Abstract: Our understanding of the development and progression of atherosclerosis has increased substantially over the past decades. A significant role for the renin-angiotensin-aldosterone system (RAAS) in this process has gained appreciation in recent years. Preclinical and clinical studies have associated components of the RAAS with various cardiovascular disease conditions. Classically known for its contribution to hypertension, dysregulation of the system is now also believed to promote vascular inflammation, fibrosis, remodeling, and endothelial dysfunction, all intimately related to atherosclerosis. The reduction in cardiovascular mortality and morbidity, as seen with the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, supports the concept that RAAS is involved in the pathogenesis of atherosclerotic disease. However, the underlying molecular mechanisms of the pathophysiology remain to be completely understood. Evidence points toward additional benefit from therapeutic approaches aiming at more complete inhibition of the system and the possible utility of renin or aldosterone in the prediction of cardiovascular outcome. This review will summarize the current knowledge from clinical studies regarding the presumptive role of renin and aldosterone in the prediction and management of patients with atherosclerosis. For this purpose, a literature search was performed, focusing on available clinical data regarding renin or aldosterone and cardiovascular outcome.
Abstract: BACKGROUND: Radial artery access is a mainstay in the diagnosis and treatment of coronary artery disease. However, there is uncertainty on the comparison of right versus left radial access for coronary procedures. We thus undertook a systematic review and meta-analysis comparing right versus left radial access for coronary diagnostic and interventional procedures. METHODS: Pertinent studies were searched in CENTRAL, Google Scholar, MEDLINE/PubMed, and Scopus, together with international conference proceedings. Randomized trials comparing right versus left radial (or ulnar) access for coronary diagnostic or interventional procedures were included. Risk ratios (RR) and weighted mean differences (WMD) were computed to generate point estimates (95% confidence intervals). RESULTS: A total of 5 trials (3210 patients) were included. No overall significant differences were found comparing right versus left radial access in terms of procedural time (WMD=0.99 [-0.53; 2.51]min, p=0.20), contrast use (WMD=1.71 [-1.32; 4.74]mL, p=0.27), fluoroscopy time (WMD=-35.79 [-3.54; 75.12]s, p=0.07) or any major complication (RR=2.00 [0.75; 5.31], p=0.49). However, right radial access was fraught with a significantly higher risk of failure leading to cross-over to femoral access (RR=1.65 [1.18; 2.30], p=0.003) in comparison to left radial access. CONCLUSIONS: Right and left radial accesses appear largely similar in their overall procedural and clinical performance during transradial diagnostic or interventional procedures. Nonetheless, left radial access can be recommended especially during the learning curve phase to reduce femoral cross-overs.
Abstract: A patient with previous implantation of two stents in the left renal artery (because of refractory arterial hypertension) developed, 7 months after implantation, a renal infarction due to late renal stent thrombosis. The early diagnosis by means of computed tomography of the abdomen and the rapid intervention by means of percutaneous balloon angioplasty lead to a favorable outcome.
Abstract: Under 35 years of age, 14% of sudden cardiac death in athletes is caused by a coronary artery anomaly (CAA). Free-breathing 3-dimensional magnetic resonance coronary angiography (3D-MRCA) has the potential to screen for CAA in athletes and non-athletes as an addition to a clinical cardiac MRI protocol. A 360 healthy men and women (207 athletes and 153 non-athletes) aged 18-60 years (mean age 31 +/- 11 years, 37% women) underwent standard cardiac MRI with an additional 3D-MRCA within a maximum of 10 min scan time. The 3D-MRCA was screened for CAA. A 335 (93%) subjects had a technically satisfactory 3D-MRCA of which 4 (1%) showed a malignant variant of the right coronary artery (RCA) origin running between the aorta and the pulmonary trunk. Additional findings included three subjects with ventral rotation of the RCA with kinking and possible proximal stenosis, one person with additional stenosis and six persons with proximal myocardial bridging of the left anterior descending coronary artery. Coronary CT-angiography (CTA) was offered to persons with CAA (the CAA was confirmed in three, while one person declined CTA) and stenosis (the ventral rotation of the RCA was confirmed in two but without stenosis, while two people declined CTA). Overall 3D MRCA quality was better in athletes due to lower heart rates resulting in longer end-diastolic resting periods. This also enabled faster scan sequences. A 3D-MRCA can be used as part of the standard cardiac MRI protocol to screen young competitive athletes and non-athletes for anomalous proximal coronary arteries.
Abstract: We discuss a case of late thrombosis, 9Â years after implantation of overlapping bare metal stents in a circumflex artery. The patient presented with an acute ST segment elevation infero-lateral myocardial infarction. The coronary angiogram revealed a sub-occlusive thrombus within the boundaries of the stents. Aspiration of the material was performed and pathological analysis showed, together with fibrin thrombus and platelet aggregates, fragments of an atherosclerotic plaque (parts of necrotic core with cholesterol clefts and inflammatory cells such as macrophages) including iron deposition, suggestive for plaque rupture. We conclude that this event occurred because of de novo atherosclerotic formation of a vulnerable, rupture-prone plaque within the boundaries of the stents.
Abstract: A 64-year-old male with an ongoing acute coronary syndrome was treated percutaneously for a subtotal occlusion of a first diagonal branch. After predilatation of the diagonal, an important secondary branch was evident at the level of the subocclusion. A jailed wire was placed in this vessel, and stenting of the main diagonal branch was performed with a last-generation thin-strut bare cobalt-chromium stent. Conventional retrieval of the jailed wire was impossible, as the distal tip of the wire remained entrapped at the level of the stent. The strong pulling of the wire led only to a deep intubation of the guiding catheter with possible risk of dissection. Retrieval of the wire was finally possible with the support of an over-the-wire microcatheter. However, the stent, though still patent, appeared deformed. At a scheduled control angiogram 4 months later (while the patient was still asymptomatic), an optical coherence tomography (OCT) investigation of the stented segment confirmed the deformation of the stent. OCT showed a complete lack of stent struts on the side of origin of the secondary branch and an "overlap" or "accumulation" of several layers of stent struts on the other side. There were no signs of uncovered struts overall nor malapposition, and even the sites where multiple stent layers were visible were completely covered by neointimal hyperplasia. Despite the multiple layers of metal, the neointimal reaction was moderate and did not lead to a flow-limiting stenosis, thus the patient was further treated medically without the need for a new intervention.
Abstract: Acute pericarditis is common, yet uncertainty persists on its treatment. We thus aimed to conduct a comprehensive systematic review on pharmacologic treatments for acute or recurrent pericarditis.
Abstract: Treatment of saphenous vein graft (SVG) disease is still a matter of debate given the uncertainty of the available conflicting data. Our aim was to assess, by means of a meta-analytic approach, the risk/benefit profile of drug eluting stents (DES) versus bare metal stents (BMS) in the treatment of SVG disease.
Abstract: Objectives. To evaluate clinical events in a specifically selected cohort of patients with obstructive coronary artery disease (CAD), using a new generation thin-strut bare cobalt-chromium coronary stent.Methods. Patients with single- or multi-vessel, stable or unstable CAD eligible for percutaneous implantation of at least one bare cobalt-chromium stent were evaluated in a single-centre registry. Prospective pre-specified criteria for bare cobalt-chromium stent implantation in our centre were: any acute ST-elevation myocardial infarction (MI), otherwise 1) de novo coronary lesion, and 2) lesion length <20 mm, and 3) reference vessel diameter >2.6 mm, and 4) no diabetes, unless reference vessel diameter >3.5 mm. Endpoints, retrospectively collected, were death, MI and clinically driven target-lesion revascularisation (TLR) and target-vessel revascularisation (TVR) after 12 months.Results. Between September 2005 and June 2007, 712 patients (48.7% one-vessel, 29.9% two-vessel, 20% three-vessel and 1.4% left main disease; 7.9% diabetics) were treated with 800 bare cobalt-chromium stents, for stable angina (40.9%), unstable angina (20.9%) or acute ST-elevation MI (38.2%). The procedural success rate was 99.3%. Peri-procedural MI rate was 2.2% in the semi-elective group. At 12 months there were 17 deaths (2.4%), of which nine non-cardiac, 20 (2.8%) MI, 19 (2.7%) TLR and 29 (4.1%) TVR. Early and late definite stent thrombosis occurred in four (0.6%) and three (0.4%) patients, respectively.Conclusion. A strategy aimed at minimising drug-eluting stent use and combining a pre-specified simple selection process with the use of a new thin-strut bare cobalt-chromium stent is safe and effective at one-year clinical follow-up. (Neth Heart J 2010;18:486-92.).
Abstract: OBJECTIVES: This study sought to assess the safety and performance of the Axxess (Devax Inc., Lake Forest, California) self-expanding drug-eluting stent in coronary bifurcation lesions. BACKGROUND: Percutaneous treatment of coronary bifurcations is a predictor of adverse late outcomes, in part because of the lack of dedicated devices. METHODS: Patients with de novo bifurcation lesions were prospectively enrolled in a multicenter study. The Axxess stent was deployed at the level of the carina followed by additional sirolimus-eluting stents in the distal parent vessel (PV) and/or side branch (SB). All patients underwent clinical follow-up at 9 months; 150 were to receive control angiography and 76 were to receive intravascular ultrasound. The primary end point was the rate of major adverse cardiac events (MACE): a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary end points included in-segment restenosis, late loss, and percent neointimal volume obstruction. RESULTS: Overall, 302 patients were treated with 299 Axxess stents (99%). Additional stenting of 1 branch was performed in 21.7% of patients (17.7% PV, 4% SB), and of both branches in 64.7%. At 9 months, 99.3% of patients returned for clinical follow-up; from the angiographic and IVUS substudies, 93.3% and 89.4% returned. The cumulative 9-month MACE rate was 7.7% (0.7% death, 3.3% non-Q-wave MI, 1.0% Q-wave MI, 4.3% TLR). Subacute and late stent thrombosis occurred in 0.7% and 0.3% of patients. Total restenosis was 6.4% (3.6% PV, 4.3% SB), late loss was 0.20 +/- 0.41 mm in the PV and 0.17 +/- 0.34 mm in the SB. In the Axxess stent segment, percent neointimal volume obstruction was 4.3 +/- 5.2%. CONCLUSIONS: This prospective multicenter study confirms the safety and performance of the Axxess stent in bifurcation lesions. (Drug-Eluting Stent Intervention for Treating Side Branches Effectively; ACTRN12606000259549).
Abstract: AIMS: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys bifurcation stent. METHODS AND RESULTS: The Stentys stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous MI and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95 +/- 3.63 mm with a bifurcation angle of 55 degrees (range 30 degrees - 80 degrees). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave MI following the procedure and one ischemia-driven revascularisation six days after the procedure. CONCLUSIONS: This first-in-man (FIM) study demonstrates that the Stentys stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.
Abstract: Coronary artery disease remains one of the most important causes of morbidity and mortality worldwide, with a disease burden that does not seem to have decreased significantly over time. Since their developments, oral drugs that are able to reduce the coagulation properties of blood (i.e., oral anticoagulants such as warfarin or dicoumarol) have been tested in thousands of patients with, or suspected with, coronary artery disease, however they have yielded disparate and conflicting results. The advent of oral antiplatelet agents has further put into a niche the apparent role of oral anticoagulant therapy in subjects with established coronary artery disease (i.e., in the setting of secondary prevention). However, the current and future role of oral anticoagulants in the secondary prevention of coronary artery disease remains very important, as testified to by the ongoing research by several major companies and investigators focusing on the development of novel oral anticoagulants. This review provides a succinct and updated appraisal of the long-term effects of chronic oral anticoagulation in the setting of coronary artery disease.
Abstract: AIMS: Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated. METHODS AND RESULTS: Using quantitative coronary angiography (QCA) data (49 bare metal stent and 44 sirolimus-eluting stent lesions) and intravascular ultrasound (IVUS) data (39 bare metal stent and 34 sirolimus-eluting stent lesions) from the randomised Reduction of Restenosis In Saphenous vein grafts with Cypher stent (RRISC) trial, we analysed the "relocation phenomenon" of QCA-based in-stent minimal luminal diameter (MLD) between post-procedure and follow-up and we correlated QCA-based and IVUS-based restenotic parameters in stented saphenous vein grafts. We expected the presence of MLD relocation for low late loss values, as MLD can "migrate" along the stent if minimal re-narrowing occurs, while we anticipated follow-up MLD to be located close to post-procedural MLD position for higher late loss. QCA-based MLD relocation occurred frequently: the site of MLD shifted from post-procedure to follow-up an "absolute" distance of 5.8 mm [2.5-10.2] and a "relative" value of 29% [10-46]. MLD relocation failed to correlate with in-stent late loss (rho = 0.14 for "absolute" MLD relocation [p = 0.17], and rho=0.03 for "relative" relocation [p = 0.811). Follow-up QCA-based and IVUS-based MLD values well correlated in the overall population (rho = 0.76, p < 0.001), but QCA underestimated MLD on average 0.55 +/- 0.49 mm, and this was mainly evident for lower MLD values. Conversely, the location of QCA-based MLD failed to correlate with the location of IVUS-based MLD (rho = 0.01 for "absolute" values--in mm [p = 0.911, rho = 0.19 for "relative" values--in % [p = 0.111). Overall, the ability of late loss to "predict" IVUS parameters of restenosis (maximum neointimal hyperplasia diameter, neointimal hyperplasia index and maximum neointimal hyperplasia area) was moderate (rho between 0.46 and 0.54 for the 3 IVUS parameters). CONCLUSIONS: These findings suggest the need for a critical re-evaluation of angiographic parameters (such as late loss) as endpoints for drug-eluting stent trials and the use of more precise techniques to describe accurately and properly the restenotic process.
Abstract: The aim of this study was to compare, in a randomized multicenter trial, paclitaxel-eluting stents (CoStar, Conor Medsystems, Menlo Park, California) versus pimecrolimus-eluting stents (Corio, Conor Medsystems) versus stents with dual elution of both drugs (SymBio, Conor Medsystems) in native coronary arteries.
Abstract: The aim of this multicentre, non-randomised trial was to evaluate the safety and efficacy at 180+/-14 days of a pimecrolimus eluting coronary stent based on a cobalt-chromium platform and a poly-L-lactic acid (PLLA) bioresorbable polymer.
Abstract: Elevation of Troponin after scheduled percutaneous coronary intervention (PCI) is a recognized consequence. We sought to evaluate the prognostic significance and impact of the newly published definition of PCI-related myocardial infarction (MI) according to which any troponin elevation >3 times the upper reference limit identify a peri-procedural MI.
Abstract: Occasionally, in post-coronary artery bypass patients multiple percutaneous revascularization choices (treatment of the native artery versus treatment of the bypass graft) are available in order to obtain adequate blood supply of the ischemic myocardial region and relief of the anginal symptoms. Once a strategy has been chosen, the possibility to switch to the alternative plan should be considered in case unpredictable complications occur during the first treatment choice. A step-by-step assessment and prediction of the possible acute and long-term outcomes and complications should always be performed in order to optimize the results.
Abstract: "StentBoost" is a new angiographic technique that allows improved angiographic visualization of stents deployed in coronary arteries, by enhancing the X-ray focus of the region where the stent is placed. Using this technique we were able to assess the deformation and the expansion of a stent deployed to treat a bifurcation lesion between the mid-left anterior descending (LAD) artery and a big second diagonal branch, during sequential inflations of: (1) the stent per se in the LAD, (2) the ostium of the diagonal branch through the stent struts, (3) the stent again with a non compliant balloon, and (4) both branches with the kissing balloon technique. "StentBoost" guided our clinical and angiographic decision-making process and allowed us to create a "virtual" bench test of the stent deployed at the level of the bifurcation treated.
Abstract: To report a systematic review of the literature published on the outcomes of stenting for below-the-knee disease in patients with critical limb ischemia (CLI).
Abstract: Coronary angiography, despite its inherent invasiveness and need for contrast media and radiographic exposure, is still routinely employed every year for the diagnostic and therapeutic management of millions of patients with or at risk for coronary artery disease. Whereas approximate visual estimation is the most common way to evaluate coronary angiography findings, since the late 1980s a number of investigators have developed and investigated methods of quantitative coronary angiography (QCA) analysis exploiting automated or semi-automated edge detection. Despite the inherent drawback of QCA due to its focus on the contrast-filled lumen of the vessel, QCA has offered and continues to offer important insights for clinical research and, in selected cases, clinical practice. This review aims thus to provide a comprehensive and updated viewpoint on the actual role of QCA.
Abstract: Selective coronary angiography was originally performed through open brachial arteriotomy. Thereafter, the percutaneous Seldinger technique and the use of preformed Judkins-type catheters popularized the femoral approach. More recently, after the first report of successful coronary angiography by the transradial approach in 1989, the radial artery has been increasingly used as an alternative access site. The main advantage offered by the transradial approach is represented by the very low (< 1%) incidence of relevant vascular access site complications, which on the contrary occur in about 3% to 7% of patients undergoing procedures through the femoral route. The main disadvantage is a higher incidence of procedural failure that leads to a crossover to the femoral route. In this review, we examine the available evidence on transradial and transfemoral approach advantages, disadvantages, and complications in coronary angiography and intervention. Their use in the acute myocardial infarction setting and other situations is described. Vascular closure device usefulness is also considered.
Abstract: Diagnosis of arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) is often challenging due to differing clinical presentations and unpredictable progression of the disease. We report a case of ARVD/C that presented as cardiac arrest in an 18-year-old male while playing soccer. The electrocardiographic features after resuscitation were typical of anterior ST-segment elevation acute myocardial infarction, and the patient was initially managed accordingly. Importantly, an urgent coronary angiogram revealed completely normal coronary arteries. ARVD/C was first suspected following an echocardiogram, and was later confirmed by cardiac magnetic resonance. One month before the event, the patient had been evaluated for ventricular extrasystoles and an abnormal resting electrocardiogram, however ARVD/C was ruled out because of the presence of only two minor diagnostic criteria (T-wave inversion in anterior precordial leads in the absence of right bundle branch block and more than 1000 ventricular extrasystoles during 24-h Holter monitoring). In consequence, physical activity was not forbidden. In conclusion, this case report enforces the need for a strict prohibition of physical activity and serial evaluation of individuals with only minor diagnostic criteria for ARVD/C, for lacking sensibility of Task Force diagnostic criteria.
Abstract: A 56 year-old woman underwent percutaneous coronary intervention for a lesion in a small mid-left anterior descending coronary artery (reference vessel diameter by quantitative coronary angiography: 2.11 mm) with a novel drug-eluting stent specifically designed for small vessels, the CardioMind Sparrow stent delivery system. This is a self-expandable sirolimus-eluting nitinol stent directly mounted into a 0.014-inch coronary guidewire. The stent has a very thin strut thickness (67 micron), limiting its radiopacity. A specific X-ray stent-enhancing visualization technique, "StentBoost", allowed clear visualization and understanding of the steps needed for an appropriate release and deployment of the aforementioned stent.
Abstract: During acute myocardial infarction (MI), the culprit lesion is usually composed of thrombus and soft plaque. Sometimes, calcification can be present. A patient with acute MI, due to sub-occlusion of the ostial right coronary artery, underwent primary percutaneous intervention. The procedure was complicated by severe dissection after balloon inflation. The use of standard materials did not allow stent passage, due to an underestimated severe calcification. To provide better support, we changed the guiding catheter for a more supportive one over the coronary guidewire, left in place to avoid rewiring the false lumen.This technique allowed successful stent deployment.
Abstract: A 62-year-old man underwent percutaneous coronary intervention of a bifurcation lesion (Medina type 010) involving the mid-left anterior descending coronary artery and an important first diagonal branch with a novel stent specifically designed for bifurcations, the Stentys coronary bifurcation system. This is a self-expanding nitinol stent, with Z-shaped struts linked by interconnections that can be disconnected (in prespecified points every 1.5 mm all around the circumference and the length of the stent) at the level of the ostium of the side branch, simply by inflating an angioplasty balloon tracked to the ostium of the side branch, through the stent struts. The steps required for deployment of the stent and the final result obtained were evaluated by intravascular ultrasound examination and StentBoost Subtract, a specific X-ray stent-enhancing visualization technique.
Abstract: OBJECTIVE: To evaluate the clinical utility of images acquired from rotational coronary angiographic (RA) acquisitions compared to standard "fixed" coronary angiography (SA). BACKGROUND: RA is a novel angiographic modality that has been enabled by new gantry systems that allow calibrated automatic angiographic rotations and has been shown to reduce radiation and contrast exposure compared to SA. RA provides a dynamic multiple-angle perspective of the coronaries during a single contrast injection. METHODS: The screening adequacy, lesion assessment, and a quantitative coronary analysis (QCA) of both SA and RA were compared by independent blinded review in 100 patients with coronary artery disease (CAD). RESULTS: SA and RA recognize a similar total number of lesions (P = 0.61). The qualitative assessment of lesion characteristics and severity between modalities was comparable and lead to similar clinical decisions. Visualization of several vessel segments (diagonal, distal RCA, postero-lateral branches and posterior-descending) was superior with RA when compared to SA (P < 0.05). A QCA comparison (MLD, MLA, LL, % DS) revealed no difference between SA and RA. The volume of contrast (23.5 +/- 3.1 mL vs. 39.4 +/- 4.1; P = 0.0001), total radiation exposure (27.1 +/- 4 vs. 32.1 +/- 3.8 Gycm(2); P = 0.002) and image acquisition time (54.3 +/- 36.8 vs. 77.67 +/- 49.64 sec; P = 0.003) all favored RA. CONCLUSION: Coronary lesion assessment, coronary screening adequacy, and QCA evaluations are comparable in SA and RA acquisition modalities in the diagnosis of CAD however RA decreases contrast volume, image acquisition time, and radiation exposure.
Abstract: Arterial revascularization by means of percutaneous transluminal angioplasty (PTA) is a mainstay in the management of patients with peripheral artery disease and critical limb ischemia (CLI). However, when employing standard approaches, PTA of below-the-knee arteries may fail in up to 20% of cases. In the present article, we report a novel interventional strategy, the "transcollateral" angioplasty approach, which we successfully employed in a patient with critical lower limb ischemia and a challenging total infrapopliteal occlusion. This technique may probably increase success rates of PTA in very challenging total occlusions of below-the-knee arteries (e.g., those lacking a proximal occlusion stump). The tips pertinent to this case are illustrated, including the need to accurately choose appropriate guidewires and balloons, and the identification of the most appropriate collateral pathway.
Abstract: OBJECTIVES: Our purpose was to perform a systematic review and meta-analysis of randomized trials comparing percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) with medical therapy in patients randomized >12 h after acute myocardial infarction (AMI). BACKGROUND: There is ongoing uncertainty about the risk-benefit ratio of late PCI in stable patients with AMI. METHODS: PubMed, CENTRAL, and other databases were searched (July 2007). Studies were included if they compared PCI with medical management and randomized patients >12 h and up to 60 days after AMI, and were excluded if patients were hemodynamically unstable. Odds ratios (ORs) were pooled for dichotomous outcomes, with all-cause mortality as the primary end point. Left cardiac remodeling parameters were also pooled with generic inverse-variance weighting. RESULTS: We retrieved 10 studies that enrolled 3,560 patients, with median time from AMI to randomization of 12 days (range 1 to 26 days), and follow-up of 2.8 years (42 days to 10 years). Randomization allocated 1,779 subjects to PCI and 1,781 to medical treatment. There were 112 (6.3%) and 149 (8.4%) deaths in the 2 groups, respectively, yielding significantly improved survival in the PCI group (OR 0.49 [95% confidence interval (CI) 0.26 to 0.94], p = 0.030). These benefits were associated with similarly favorable effects on cardiac remodeling, such as improved left ventricular ejection fraction in the PCI group (+4.4% change [95% CI 1.1 to 7.6], p = 0.009). CONCLUSIONS: Percutaneous coronary intervention of the IRA performed late (12 h to 60 days) after AMI is associated with significant improvements in cardiac function and survival.
Abstract: It was the aim of this study to investigate the long-term value of transesophageal atrial pacing in predicting death in patients with known or suspected coronary artery disease.
Abstract: First-generation drug-eluting stents (DES) have brought major improvements in results of percutaneous coronary intervention (PCI). However, there is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. Second-generation DES, such as zotarolimus- (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. Indeed, the Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety, yet there is uncertainty on its risk-benefit balance. Authors conducted a systematic review of basic science and clinical evidence on the Xience V, by thoroughly searching PubMed and online databases (updated September 2007). They also compared the clinical results of Xience V vs paclitaxel-eluting stents (Taxus) and sirolimus-eluting stents (Cypher) by means of direct and indirect comparison meta-analysis. A total of three clinical studies has been retrieved focusing on Xience V, however both most recent and important trials were still unpublished. The first trial compared Xience V vs bare-metal stents, whereas the other two randomized trials compared Xience V vs Taxus. Direct meta-analysis of Xience V vs Taxus showed that Xience V was significantly superior to Taxus in preventing binary angiographic restenosis and target lesion revascularization (P<0.05 for both). Indirect comparison between Xience V and Cypher, exploiting a recent 16-trial large meta-analysis, showed that Xience V was at least as effective as Cypher in preventing target lesion revascularization (P=0.12). Everolimus-eluting stents (Xience V) appear as a major breakthrough in coronary interventions, and superior efficacy has already been demonstrated in comparison to paclitaxel-eluting stents (Taxus). Data available to date also suggest that Xience V is at least as effective as sirolimus-eluting stents (Cypher). Whether long-term results and direct comparison to Cypher will also be favorable remains to be established by future clinical trials.
Abstract: Despite proven advantages of primary percutaneous coronary intervention (PCI), thrombolysis remains the first line treatment for ST-elevation myocardial infarction (STEMI) worldwide. Management of patients with failed thrombolysis is still debated, and data from existing randomized controlled trials are conflicting.
Abstract: OBJECT: Pexelizumab is a humanized monoclonal antibody inhibiting C5 complement. It has been postulated to improve outcomes in patients undergoing coronary artery bypass surgery and urgent reperfusion therapy for ST elevation myocardial infarction. We aimed at evaluating the risk/benefit profile of pexelizumab (bolus + infusion) versus placebo on top of current approaches in the management of patients with ST elevation myocardial infarction or undergoing coronary artery bypass. METHODS: We conducted a search of BioMedCentral, CENTRAL, mRCT, and PubMed without language restrictions (updated October 2007) for randomized controlled trials. Outcomes of interest were the risk of major adverse events (the composite of all-cause death, myocardial infarction, and thromboembolic stroke), the risk of single end points, and heart failure. RESULTS: Seven trials were included (15,196 patients: 7019 patients with ST elevation myocardial infarction and 8177 undergoing coronary bypass surgery). No benefit of adding pexelizumab was found in the overall analysis for major adverse events (OR 0.91 [0.76-1.09]; P = .29], death (OR 0.79 [0.61-1.03], P = .11], myocardial infarction (OR 1.04 [0.89-1.22]; P = .14), stroke (OR 0.95 [0.66-1.38]; P = .8), heart failure (OR1.0 [0.82-1.22]; P = .99), nor in the settings of patients with ST elevation myocardial infarction treated with mechanical or pharmacologic reperfusion therapy. Pexelizumab was associated with a 26% reduction of the risk of death in the setting of coronary artery bypass (OR 0.74 [0.58-0.94]; P = .01). The number needed to treat was 100. CONCLUSION: Our data ruled out the hypothesis of any benefit of adding pexelizumab on top of currently available therapies for ST elevation myocardial infarction. However, pexelizumab reduces the risk of death in patients undergoing coronary artery bypass grafting.
Abstract: BACKGROUND: Sirolimus-eluting stents (SES) prevent restenosis and repeat percutaneous coronary intervention (PCI), but safety data in unselected patients are limited, especially for intermediate-term follow-up. METHODS: All patients undergoing SES implantation at 4 Italian centers were enrolled into a dedicated database. Baseline, procedural, and outcome data at discharge and at follow-up were abstracted. Outcomes of interest were the occurrence of major adverse cerebrocardiovascular events (MACCE) at 6 months, as well as long-term event-free survival and multivariable event predictors. RESULTS: One thousand four hundred twenty-four patients were enrolled (2,915 lesions, treated with 3,305 stents). Specifically, 1,074 (75.4%) subjects had multivessel disease, 399 (28.1%) had diabetes, 89 (6.3%) had ST-elevation myocardial infarction, and 44 (3.1%) underwent unprotected left main intervention. At 6 months, MACCE had occurred in 121 (9.0%) patients. After a median of 48.7 months (first-third quartile 41.8-55.3), MACCE-free survival was 69.2%+/-2.6%, with definite stent thrombosis occurring acutely in 6 (0.4%), subacutely in 11 (0.8%), after 30 days in 12 (0.8%), and cumulatively in 28 (2.0%). Major multivariable outcome predictors were diabetes (target lesion revascularization [TLR], MACCE), ejection fraction (TLR, MACCE), and maximal balloon length (TLR). CONCLUSIONS: This large cohort of unselected patients supports the overall safety of unrestricted percutaneous SES implantation, as shown by the low rates of stent thrombosis. Event attrition remains, however, high at long-term follow-up, driven mainly by target vessel revascularization, with diabetes and ejection fraction as the most important prognostic factors.
Abstract: BACKGROUND: Cardiac surgery is the standard treatment for unprotected left main disease (ULM). Drug-eluting stent (DES) implantation has been recently reported in patients with ULM but with unclear results. We systematically reviewed outcomes of percutaneous DES implantation in ULM. METHODS: Several databases were searched for clinical studies reporting on > or = 20 patients and > or = 6-month follow-up. The primary end point was major adverse cardiovascular events (MACEs; ie, death, myocardial infarction, or target vessel revascularization [TVR]) at the longest follow-up. Incidence and adjusted risk estimates were pooled with generic inverse variance random-effect methods (95% CIs). RESULTS: From 823 initial citations, 16 studies were included (1278 patients, median follow-up 10 months). Eight were uncontrolled registries, 5 nonrandomized comparisons between DES and bare-metal stents and 3 nonrandomized comparisons between DES and CABG, with no properly randomized trial. Meta-analysis for DES-based PCI showed, at the longest follow-up, rates of 16.5% (11.7%-21.3%) MACE, 5.5% (3.4%-7.7%) death, and 6.5% (3.7%-9.2%) TVR. Comparison of DES versus bare-metal stent disclosed adjusted odds ratios for MACE of 0.34 (0.16-0.71), and DES versus CABG showed adjusted odds ratios for MACE plus stroke of 0.46 (0.24-0.90). Meta-regression showed that disease location predicted MACE (P = .001) and TVR (P = .020), whereas high-risk features predicted death (P = .027). CONCLUSIONS: Clinical studies report apparently favorable early and midterm results in selected patients with ULM. However, given their limitations in validity and the inherent risk for DES thrombosis, results from randomized trials are still needed to definitely establish the role of DES implantation instead of the reference treatment, surgery.
Abstract: BACKGROUND: Drug-eluting stents reduce the risk of restenosis after percutaneous coronary intervention (PCI) but may pose a risk of thrombosis. Cilostazol, an oral antiplatelet agent with pleiotropic effects including inhibition of neointimal hyperplasia, could hold the promise of preventing both restenosis and thrombosis. We systematically reviewed randomized clinical trials (RCTs) on the angiographic and clinical impact of cilostazol after PCI. METHODS: We searched RCT in BioMedCentral, CENTRAL, clinicaltrials.gov, EMBASE, and PubMed (November 2007). Coprimary end points were binary angiographic restenosis and repeat revascularization, abstracted and pooled by means of random-effect relative risks (RRs). Small study/publication bias was appraised with multiple methods. RESULTS: A total of 23 RCTs were included (5428 patients), with median follow-up of 6 months. Pooled analysis showed that cilostazol was associated with statistically significant reductions in binary angiographic restenosis (RR = 0.60 [0.49-0.73], P < .001) and repeat revascularization (RR = 0.69 [0.55-0.86], P = .001). Cilostazol appeared also safe, with no significant increase in the risk of stent thrombosis (RR = 1.35 [0.71-2.57], P = .36) or bleeding (RR = 0.71 [0.43-1.16], P = .17). However, small study bias was evident for both binary restenosis (P < .001) and repeat revascularization (P < .001), suggesting that at least part of the apparent benefits of cilostazol could be due to this type of confounding effect. CONCLUSIONS: Cilostazol appears effective and safe in reducing the risk of restenosis and repeat revascularization after PCI, but available evidence is limited by small study effects. Awaiting larger RCTs, this inexpensive treatment can be envisaged in selected patients in which drug-eluting stents are contraindicated or when there is a need for neointimal hyperplasia inhibition.
Abstract: Vessel foreshortening is a major limitation of standard coronary angiography due to the 2-dimensional representation of 3-dimensional structures. Three-dimensional models may overcome it. The aim of this study was to compare measurements of coronary segments from quantitative coronary angiography (QCA) in an operator-selected "working view" of standard 2-dimensional coronary angiography with those from 3-dimensional coronary angiography (3D-CA) reconstruction models, which are automatically generated from software applied to rotational coronary angiographic acquisitions. Patients who underwent percutaneous coronary intervention were considered. Two or 3 segments of the artery needing treatment were prespecified, using bifurcations as edges. The operator selected a working view from standard angiography as the view best representing each segment. Rotational angiography was performed, allowing 3-dimensional reconstruction of the selected segments. Additionally a marker guidewire (with 4 markers 10 mm away from one another at the distal tip) was used to further measure segment length, and it was considered the "gold standard" reference. In 36 patients, 81 segments from 12 left anterior descending, 12 circumflex, and 12 right coronary arteries were evaluated. Three-dimensional coronary angiography was always feasible. Although reference vessel diameter was not different between 3D-CA and QCA (p >0.05), segment length measurements were on average 2.3 +/- 2.5 mm longer with 3D-CA than with QCA (p <0.001) and 0.4 +/- 1.8 mm longer than with marker guidewire measurement (p = 0.047). Marker guidewire measurements were 1.9 +/- 2.8 mm longer than QCA measurements (p <0.001). According to Bland-Altman plots, 3D-CA and marker guidewire measurements had the best agreement. In conclusion, 3-dimensional coronary modeling is highly feasible and yields more accurate assessments of the lengths of coronary segments than standard QCA.
Abstract: After acute coronary syndromes, the beneficial effect of aspirin plus clopidogrel (A+C) or aspirin plus dose-adjusted warfarin (A+W) compared with aspirin alone is well established. However, these regimens were never compared. To compare the risk-benefit profile of A+C versus A+W after acute coronary syndromes, major medical databases for randomized controlled trials comparing 1 of these combined approaches versus aspirin alone after an acute coronary syndrome (updated June 2006) were searched. Evaluated end points were major adverse events [MAEs: all-cause death, acute myocardial infarction [AMI], thromboembolic stroke, major bleeds, and overall risk of stroke [hemorrhagic or ischemic]). Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for (1) A+W versus aspirin alone, (2) A+C versus aspirin alone, and (3) A+W versus A+C using adjusted indirect meta-analysis. Thirteen studies were included, totaling 69,741 patients. Ten compared A+W versus aspirin alone and 3 compared A+C versus aspirin alone. Each combined approach yielded a significantly lower risk of MAEs, albeit an increased risk of major bleeds, compared with aspirin alone. No significant difference was found for A+W versus A+C for risk of overall MAEs, death, or AMI. However, A+W versus A+C was associated with a significantly lower risk of thromboembolic stroke (OR 0.53, 95% CI 0.31 to 0.88, number needed to treat 60) and all types of stroke (OR 0.58, 95% CI 0.35 to 0.94, p=0.038), but also with increased risk of major bleeds (OR 1.9, 95% CI 1.2 to 2.8, number needed to harm 300). In conclusion, after an acute coronary syndrome, A+W and A+C are comparable in the prevention of MAEs, death, and AMI compared with aspirin alone. Allocating 100 patients to A+W (at international normalized ratio 2 to 3) with respect to A+C could prevent 17 thromboembolic strokes while causing 3 major bleeds.
Abstract: OBJECTIVES: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients. BACKGROUND: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent. METHODS: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis. RESULTS: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61). CONCLUSIONS: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.
Abstract: The implantation of coronary stents is a relevant part of interventional procedures for percutaneous revascularization. The wide acceptance of coronary stenting was based on the results of two highly significant trials which have shown the superiority of stenting over balloon angioplasty in terms of reduction of angiographic restenosis and need for repeated intervention in focal lesions and large coronary arteries. Since then, the growing use of stent market was impressive. A rapidly increasing number of different stent type with different material and designs has been introduced in the market both for bare metal stent and drug eluting stent. This review will summarize the different components of stent design that are important in term of biological response of the arterial wall and clinical outcome. In addition, new stent platforms, mainly represented by the biodegradable stent will be shortly reviewed since it may provide in the near future a more "physiological" answer to stent implantation, reducing vascular injury and accelerating vessel healing with consequent improving in clinical outcome.
Abstract: We discuss two cases of non-occlusive sub-acute/late stent thrombosis, one correctly diagnosed (with the help of intravascular ultrasound) 12 days after implantation of a sirolimus eluting stent, the other erroneously non recognized 17 days after implantation of a bare metal stent and evolving 6 weeks later in total thrombotic occlusion of the stent itself. We believe that our clinical judgment, accurate in case of sirolimus eluting stent thrombosis, but wrong in case of bare metal stent thrombosis, was largely influenced by the recent literature giving overwhelming attention, in the drug-eluting stent era, to an issue (late stent thrombosis) that was already present but under-considered, also in the bare metal stent era.
Abstract: Late loss is becoming an important end point to compare drug-eluting stents; however, little is known about its pattern of distribution. We analyzed the pattern of late loss distribution in sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) in a consecutive cohort of patients. From a cohort of 529 patients treated with drug-eluting stents in 1 year, we selected all patients who underwent angiographic follow-up. Three hundred fifty-nine patients with 592 de novo lesions received SESs (286 lesions) or PESs (306 lesions). Late loss and binary angiographic restenosis were analyzed. Binary restenosis occurred in 56 lesions (19.6%) treated with SESs compared with 53 (17.3%) treated with PESs (p = 0.48). The 2 late loss distributions were skewed to the right and were not normally distributed (p <0.001 for SES, p = 0.003 for PES). Late loss was significantly lower in the SES group (p = 0.03), with a median value of 0.29 mm (interquartile range -0.09 to 0.66) versus 0.41 mm (-0.02 to 0.85) in the PES group. When analyzing only restenotic lesions, late loss had a normal distribution in the SES and PES groups (p = 0.96 and 0.44, respectively) and was similar in the 2 groups (1.75 +/- 0.51 vs 1.82 +/- 0.62, p = 0.48). When evaluating nonrestenotic lesions, late loss was also normally distributed in the 2 groups (p = 0.75 for SES, p = 0.73 for PES) but was significantly lower (p = 0.002) after SES implantation (0.14 +/- 0.39) than after PES implantation (0.27 +/- 0.44). In conclusion, SESs and PESs have a bimodal pattern of late loss distribution. The observed difference in late loss between SES and PES seems to be partly explained by the decrease in late loss after SES implantation in nonrestenotic lesions (where SES approaches "zero late loss"). Thus, late loss may not be a reliable marker of the true efficacy of these devices due to its complex and nongaussian distribution.
Abstract: BACKGROUND: Current treatment standards for patients undergoing primary percutaneous coronary intervention support early infusion of abciximab, followed by bare-metal stent (BMS) implantation. Whether the use of sirolimus-eluting stent (SES) would result in a further improvement of clinical outcomes remains to be proven. Similarly, whether tirofiban administered at high-bolus dose (HBD) followed by standard infusion is a valuable alternative to abciximab in the setting of ST-segment elevation myocardial infarction remains uncertain. STUDY DESIGN: Multicentre evaluation of single high-bolus dose tirofiban versus abciximab and sirolimus-eluting versus bare metal stent in acute myocardial infarction (MULTI-STRATEGY) is a phase III, open-label, multinational investigator-driven clinical trial evaluating, with a 2-by-2 factorial design, the safety/efficacy profile of 4 interventional strategies of reperfusion: tirofiban given at HBD (bolus of 25 microg/kg over 3 minutes), followed by an infusion of 0.15 microg/kg per minute for 18 to 24 hours versus abciximab and SES, as compared to BMS implantation in primary percutaneous coronary intervention. The coprimary objectives are (i) the evaluation of the effect of SES versus BMS on the incidence of major adverse cardiac events within 8 months of the index procedure and (ii) the degree of ST-segment resolution obtained after the mechanical intervention for the comparison of HBD tirofiban versus abciximab. The protocol mandates clinical follow-up for 5 years. CONCLUSIONS: MULTI-STRATEGY will evaluate the role of SES and HBD tirofiban versus BMS and abciximab in the acute management of patients presenting with ST-segment elevation myocardial infarction.
Abstract: Rupture of vulnerable plaques is the main cause of acute coronary syndromes and myocardial infarctions. Identification of these vulnerable plaques is therefore essential to enable the development of treatment modalities to stabilize them. Several intravascular technologies, investigating coronary areas that will be responsible for future events, are highlighted in this review. The ideal technique would provide morphological, mechanical and biochemical information. Although several imaging techniques are currently under development, none of them alone provides such an all-embracing assessment. Optical coherence tomography has the advantage of high resolution, thermography has the potential to measure metabolism, and Raman spectroscopy obtains information on chemical components. Intravascular coronary ultrasound (IVUS) and IVUS-palpography are easy to perform and assess morphology and mechanical instability. Shear stress is an important mechanical parameter deeply influencing vascular biology. Nevertheless, all these techniques are still under investigation and, at present, none of them can unequivocally and comprehensively identify a vulnerable plaque and, most importantly, predict its further development. From a clinical point of view, most techniques currently assess only one feature of the vulnerable plaque. Thus, a combination of several modalities will be important in the future to ensure a high sensitivity and specificity in detecting vulnerable plaques.
Abstract: There is ongoing debate to identify the most effective, safe and cost-beneficial drug-eluting stent, between the two currently approved and used devices, i.e. sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). To date, head-to-head comparison studies of SES vs PES have been however limited by relatively small sample sizes and the low number of events typically associated with these highly effective coronary devices. To overcome the drawbacks of single trials, direct and indirect comparison meta-analyses have been designed and conducted to thoroughly compare sirolimus- vs paclitaxel eluting-stents. This article provides results of a pooled analysis of such indirect and direct comparisons, definitively demonstrating across 5854 patients the superiority of SES in comparison to PES (odds ratio 0.62 [95% confidence interval 0.50-0.75], p<0.0001 for binary angiographic restenosis, and odds ratio 0.66 [0.52-0.84], p=0.0008 for target lesion revascularization). Indeed, such combination of direct and indirect comparisons should also be envisaged to soundly and timely appraise the next generation of drug-eluting stents.
Abstract: A 51 year-old man underwent percutaneous coronary intervention of a significant "true" bifurcation lesion involving the proximal left anterior descendens (LAD) artery and an important first diagonal branch with a dedicated bifurcation stent, which is a conical self-expandable biolimus-eluting stent with a "flared" distal part allowing for optimal scaffolding of the carina of the bifurcation, and two additional sirolimus-eluting stents, deployed with the V-stenting technique, one in the LAD and one in the diagonal branch, in overlap with the distal part of the "flared" biolimus-eluting stent. An X-ray enhancing visualization technique, "StentBoost Subtract," was used to obtain an improved visualization of the stent in relation to the corresponding vessel lumen and revealed good expansion of all the stents and good apposition to the vessel wall.
Abstract: BACKGROUND: Clopidogrel is an established alternative to ticlopidine in addition to aspirin after coronary stenting because of its safety, but its optimal initial dosing is unclear. We performed a systematic review and meta-regression of randomized clinical trials comparing clopidogrel versus ticlopidine, focusing on clopidogrel front-loading. METHODS: PubMed was searched for pertinent studies (updated August 2006). Random-effect odds ratios (ORs) with 95% CIs were computed for death or nonfatal myocardial infarction, and weighted least squares random-effect meta-regression was performed to explore the impact of loading versus nonloading clopidogrel scheme. RESULTS: We retrieved 7 trials (3382 patients, average follow-up of 7 months). In 5 studies, both clopidogrel and ticlopidine were started with a loading dose, in 1 trial clopidogrel was administered without loading, and in 1 trial clopidogrel could be administered with or without loading. Overall analysis (P for heterogeneity = .02) showed similar results for clopidogrel and ticlopidine (OR 0.90, 95% CI 0.44-1.84, P = .77). In studies administering clopidogrel with loading, this treatment was, however, significantly better than ticlopidine (OR 0.60, 95% CI 0.36-0.99, P = .05). This significant interaction between clopidogrel loading and its superiority in comparison with ticlopidine was also formally confirmed by meta-regression (beta = -0.64, P = .012). CONCLUSIONS: This work supports the superiority of a clopidogrel regimen including an initial loading dose in comparison with ticlopidine in patients undergoing coronary stenting.
Abstract: Coronary revascularization procedures by means of percutaneous coronary interventions or coronary artery bypass graft surgeries are performed worldwide daily for the symptomatic treatment of patients with myocardial ischaemia. Nevertheless, angina remains a significant clinical problem. Management of angina recurring or persisting after coronary revascularization is particularly challenging. This review attempts to summarize the most common causes of recurrent chest pain after coronary revascularization, to analyse the possible diagnostic approaches, and to discuss the potential treatment modalities.
Abstract: BACKGROUND: The safety and efficacy of drug-eluting stents (DES) implantation in unprotected left main (LM) bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term outcome following implantation of DES in unprotected LM bifurcation lesions. METHODS: We identified 70 consecutive patients treated with DES in unprotected LM bifurcation lesions from April 2003 to January 2005. Of them, 42 patients were treated with sirolimus-eluting stent (SES) and 28 patients were treated with paclitaxel-eluting stent (PES). RESULTS: Stents to the left anterior descending and to the circumflex were implanted in 62 patients. During 1-year follow-up, 3 (4.3%) patients died of cardiac causes. One of them had myocardial infarction and adjudicated as possibly due to stent thrombosis. Angiographic follow-up was available in 80% of patients. The per lesion restenosis rate was 13.4% in the entire cohort, of which 10.7% occurred in lesions treated with SES and 16.1% in those treated with PES (P = 0.58). All restenosis was focal and occurred in the lesions treated with a stent with stent size to post-procedural reference vessel diameter ratio < 1.0 (17.6% vs 0, P = 0.04). The per patient target lesion revascularization rate at 1 year was 17.1%. One year survival free from major adverse cardiac events was 77.1%. CONCLUSIONS: Treatment of LM bifurcation lesions using DES is a safe and feasible way with a low one-year mortality. The need for revascularization in 17% of patients demands for improvement.
Abstract: BACKGROUND: Paclitaxel-eluting stents (PES) have been proved effective in randomized trials enrolling highly selected patients. Yet, given the uncertainty concerning results of PES implantation in very high-risk patients and lesions, we designed a prospective multicenter registry, the Taxus in Real-life Usage Evaluation (TRUE) Study. STUDY DESIGN, PATIENT CHARACTERISTICS AND IN-HOSPITAL OUTCOMES: Consecutive patients undergoing PES implantation were enrolled provided that the target lesion treated with PES was an unprotected left main (ULM), a true bifurcation, a chronic total occlusion (CTO), a long lesion (>28 mm), located in a small vessel (<2.75 mm), or the patient had diabetes mellitus. Clinical events will be adjudicated at 1, 7 and 12 months, with 4- to 8-month angiographic follow-up. The primary end-point will be the 7-month occurrence of major adverse cardiovascular events (MACE, i.e. the composite of cardiac death, non-fatal myocardial infarction [MI], coronary artery bypass grafting [CABG] and percutaneous target vessel revascularization [TVR]). To date, patient enrollment has been completed reaching the target of 1065 subjects. These included 322 (30.2%) diabetics, 115 (10.8%) subjects undergoing PES implantation for ULM, 229 (21.5%) in a bifurcation, 191 (17.9%) in a CTO, 430 (40.4%) in a small vessel, and 289 (27.1%) in a long lesion. An average of 1.5+/-0.6 vessels and 2.0+/-1.0 lesions were treated per patient, with 2.0+/-1.2 PES implanted per patient, and a 46+/-30 mm total PES length per patient. In-hospital MACE occurred in 39 (3.7%) patients, with 2 (0.2%) cardiac deaths, 32 (3.0%) MI, 5 (0.5%) TVR, no CABG, and 4 (0.4%) acute stent thromboses. IMPLICATIONS: Despite the availability of randomized trials, only carefully designed and prospective registries can provide timely and accurate assessment of the risk-benefit profile of PES in very high-risk patients. Indeed, the TRUE Study, including as much as 115 ULM and 229 bifurcation interventions, should give important insights into the outcome of PES in such an unprecedented and challenging context.
Abstract: The percutaneous treatment of patients with obstructive atherosclerotic disease in diseased coronary saphenous vein bypass grafts still remains a challenge in interventional cardiology. We discuss the actual evidence-based knowledge for the percutaneous management of this lesion subset, focusing on the devices that are actually considered the gold standard for this treatment: bare-metal stents and distal protection devices. We also comment the negative results of the trials regarding the promising covered stent-grafts. We finally offer insights into the currently available evidence for the use of drug-eluting stents in saphenous vein grafts. These devices are potentially a promise for the successful sealing of vein graft disease, however, available long-term safety and effectiveness data are conflicting and give reason for caution.
Abstract: The direct thrombin inhibitor, ximelagatran, and its active form, melagatran (X/M), have been compared against conventional anticoagulant therapy (CAT) in many clinical settings. Their risk-benefit profile drove large debate until withdrawal by the manufacturer. A systematic review of all published randomized trials has been performed and a meta-analysis of randomised controlled trial (RCT) of X/M versus CAT. Major medical databases were searched for RCTs. Major adverse events (MAE: all cause death, nonfatal myocardial infarction, nonfatal thromboembolic stroke, pulmonary embolism), major bleeds (MB), minor bleeds and the rate of hepatotoxicity (HT) were compared. In terms of efficacy, X/M was at least as effective as, or even superior to, CAT. In terms of safety, the overall risk of MAE, MB, minor bleeds and HT was not significantly different for X/M compared with CAT. According to individual clinical settings, X/M was associated with a lower risk of MB but a prohibitive higher risk of HT in those clinical settings requiring prolonged treatment.
Abstract: Combined antiplatelet treatment with aspirin and clopidogrel is pivotal to minimize periprocedural adverse events in patients who undergo percutaneous coronary intervention. However, there is debate on the best clopidogrel loading dose. The investigators performed a systematic review and meta-analysis of the optimal clopidogrel loading dose. Pertinent trials comparing high (>300 mg) and standard (300 mg) clopidogrel loading doses in patients scheduled for catheterization and/or percutaneous coronary intervention were systematically searched in BioMedCentral, CENTRAL, Google Scholar, and PubMed (December 2006). The primary end point was the 1-month rate of death or myocardial infarction. Secondary end points included other ischemic and bleeding adverse effects. Peto odds ratios were computed. A total of 10 studies (7 randomized, 3 nonrandomized) were included, enrolling 1,567 patients (712 loaded with 300 mg, 11 with 450 mg, 790 with 600 mg, and 54 with 900 mg). Overall, a high loading dose proved significantly superior to a standard loading dose in preventing cardiac death or nonfatal myocardial infarction (odds ratio 0.54, 95% confidence interval 0.32 to 0.90, p = 0.02), without any statistically significant increase in major or minor bleedings (p = 0.55 and p = 0.98, respectively). Sensitivity analysis restricted to randomized trials confirmed the superiority of a high loading dose regimen (p = 0.0031). Meta-regression disclosed a significant interaction between event rate and the benefits of high loading doses (p = 0.005), suggesting that the greater the underlying risk, the greater the favorable impact of a high loading dose. In conclusion, a high clopidogrel loading dose (>300 mg) significantly reduces early ischemic events in patients scheduled for percutaneous coronary intervention.
Abstract: Aims: Paclitaxel-eluting stents (PES) have been proved safe and effective in selected patients undergoing percutaneous coronary interventions (PCI). However, there is uncertainty on the performance of PES in real-world patients at higher risk for major adverse cardiovascular events (MACE) or restenosis. We conducted a multicentre registry enrolling very high-risk subjects treated with PES.Methods and results: We enrolled 1,065 consecutive patients undergoing PES implantation, provided that the target lesion treated with the PES was an unprotected left main (N=113), a true bifurcation (N=219), a chronic total occlusion (CTO, N=183), a long lesion (>28 mm, N=283), in a small vessel (<2.75 mm, N=417), or the patient had medically-treated diabetes mellitus (N=315). Clinical events were adjudicated at 1 and 7 months, and 4 to 8-month angiographic follow-up was recommended for core-lab quantitative coronary angiography. The primary end-point was the 7-month occurrence of MACE, i.e., the composite of cardiac death, non-fatal myocardial infarction (MI), coronary artery bypass grafting (CABG) and percutaneous target vessel revascularisation (TVR). A total of 2,116 lesions were treated with 2.0+/-1.2 Taxus per patient and 46.4+/-30 total Taxus length per patient. One total Taxus length per patient. One-month MACE occurred in 4.3% of patients, with 0.4% cardiac death, 3.3% myocardial infarction (MI), 0.1% coronary artery bypass grafting (CABG), and 0.8% target vessel revascularisation (TVR) PCI. Seven-month events were as follows: MACE 20.4%, cardiac death 1.2%, MI 4.2%, CABG 1.2%, TVR-PCI 15.4% and target lesion revascularisation (TLR)-PCI 10.9%. Binary restenosis occurred in 20.7% out of the 1,071 lesions undergoing follow-up angiography. Finally. stent thrombosis (ST) was reported with a 0.8% 12-month cumulative rate (0.3% acute, 0.3% subacute, and 0.2% <6 months, but no thrombosis >6 months).Conclusions: This registry, enrolling 1,065 high-risk patients treated with PES, confirms the satisfactory performance of this device, especially given the overall profile of enrolled subjects and the limited number of stent thromboses.
Abstract: Aims: There is uncertainty on the clinical outcomes of percutaneous coronary intervention (PCI) in patients with left ventricular dysfunction (LVD). We thus performed a systematic review of studies reporting on PCI in LVD.Methods and results: Pertinent studies were searched in PubMed, and included if reporting on >/=30 patients, with ejection fraction < 50%, and prevalently (>60%) treated with stents. The primary endpoint was the occurrence of major adverse cardiovascular events (MACE) at the longest follow-up. Outcomes were pooled with random-effect methods (95% confidence intervals). We retrieved 11 studies including 1,284 patients with ejection fraction <50% (specifically <40% in 1,033 and <30% in 211). All studies but one reported on bare-metal stenting only. In-hospital MACE occurred in 5% (3-6), with death in 2% (1-3), myocardial infarction in 3% (2-4), and repeat revascularisation in 1% (0-2). After a median of 18 months, MACE occurred in 33% (30-36), with death in 11% (9-13), myocardial infarction in 7% (6-9), and repeat revascularisation in 15% (13-18). Meta-regression suggested the beneficial impact of drug-eluting stents on MACE (p=0.030).Conclusions: Currently available data support the adoption of percutaneous revascularisation in carefully selected patients with LVD. While event attrition remains substantial at long-term follow-up, drug-eluting stents hold the promise of significantly improving event-free and overall survival.
Abstract: The safety of drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention has been questioned in several independent meta-analyses (i.e., systematic reviews of primary research studies employing statistical methods to provide pooled estimates) published or presented at the end of 2006. Other reviews and meta-analyses have followed in the beginning of 2007, albeit with unclear or conflicting results. This article provides a succinct perspective and critical appraisal of recently published meta-analyses focusing on DES safety, summarising key features and findings of each work, and recommending avenues for further research and practice.
Abstract: OBJECTIVES: We sought to provide long-term follow-up data of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVG) from the RRISC (Reduction of Restenosis In Saphenous vein grafts with Cypher) trial. BACKGROUND: We have previously shown that, in SVG, the use of SES reduces 6-month restenosis and repeated revascularization procedures versus the use of BMS. These data are consistent with trials in native coronary arteries. However, recently published long-term follow-up data of these trials have revealed an increased risk of adverse events (particularly very late stent thrombosis) after SES. METHODS: A total of 75 patients with 96 SVG lesions were randomized to SES versus BMS. All patients underwent clinical follow-up up to 3 years. Specific outcomes assessed in this secondary post-hoc analysis were all-cause mortality, myocardial infarction, and target vessel revascularization. RESULTS: Thirty-eight patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. At a median follow-up time of 32 months (interquartile range 26.5 to 36 months), 11 deaths (7 cardiac, of which 1 was caused by very late stent thrombosis and, 3 were sudden) occurred after SES (29% [95% confidence interval (CI) 17% to 45%]) versus 0 after BMS (0% [95% CI 0% to 9%]) with an absolute difference of 29% ([95% CI 14% to 45%], p < 0.001). The rates of myocardial infarction and target vessel revascularization were not different: 18% and 34% after SES, respectively, versus 5% and 38% after BMS, respectively (p = 0.15 and p = 0.74, respectively). CONCLUSIONS: In this secondary post-hoc analysis, BMS were associated with lower long-term mortality than SES for SVG disease. Also, the 6-month reduction in repeated revascularization procedures with SES was lost at longer-term follow-up. (RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent; http://clinicaltrials.gov/ct/show/NCT00263263?order=1; NCT00263263).
Abstract: BACKGROUND: The GuardWire distal protection device reduces the incidence of periprocedural complications during percutaneous stenting of diseased saphenous vein grafts. Its mechanism of action is based on the occlusion of the vessel distal to the lesion with an inflated compliant balloon before the intervention, and the aspiration of embolized material after stent implantation. Although no safety issues related to the compliant balloon have been reported in vein graft treatment, concerns related to the potential injury of the balloon on the vessel wall have been raised. We thus evaluated the angiographic outcome of the vein graft segment where the compliant balloon of the GuardWire distal protection device was inflated during percutaneous interventions of diseased vein grafts. METHODS: Forty consecutive patients undergoing vein graft stenting, all with successful delivery of the GuardWire system, were enrolled. All patients underwent 6-months follow-up angiography. Quantitative coronary angiographic analysis of the vein graft segment where the balloon was inflated was performed before and after the procedure, as well as at 6-month follow-up. RESULTS: No differences in reference vessel diameter, minimal luminal diameter and diameter stenosis were evident between the three measurements. In particular, the difference between post-procedural and follow-up minimal luminal diameter (namely late loss) was 0.003+/-0.19 mm (95% confidence interval: -0.06-0.06). CONCLUSIONS: This prospective study supports for the first time the "angiographic safety" of low pressure inflations of a compliant balloon in saphenous vein grafts, suggesting the absence of acute and mid-term effects on the vein graft vessel wall.
Abstract: To assess the temporal effect of statin therapy on coronary atherosclerotic plaque volume measured by intravascular ultrasound (IVUS), we searched PubMed for eligible studies published between 1990 and January 2006. Inclusion criteria for retrieved studies were (1) IVUS volume analysis at baseline and follow-up and (2) statin therapy in > or =1 group of patients. All data of interest were abstracted in prespecified structured collection forms. Statistical analysis was performed with Review Manager 4.2. Random-effect weighted mean difference (WMD) was used as summary statistics for comparison of continuous variables. Nine studies of 985 patients (with 11 statin treatment arms) were selected. After a mean follow-up of 9.8 +/- 4.9 months, we found a significant decrease in coronary plaque volume (WMD -5.77 mm(3), 95% confidence interval -10.36 to -1.17, p = 0.01), with no significant heterogeneity across studies (p = 0.47). Prespecified subgroup analyses showed similar trends. Studies in which the achieved low-density lipoprotein (LDL) cholesterol level was <100 mg/dl showed a trend for plaque regression (WMD -7.88 mm(3), 95% confidence interval -16.31 to 0.55, p = 0.07), whereas studies in which the achieved level of LDL cholesterol was > or =100 mg/dl, the trend was less evident (WMD -4.22 mm(3), 95% confidence interval -10.27 to 1.82, p = 0.17). Plaque volume remained essentially unchanged in patients not treated with statins (WMD 0.13 mm(3), 95% confidence interval -4.42 to 4.68, p = 0.96). In conclusion, statin therapy, particularly when achieving the target LDL level, appears to promote a significant regression of coronary plaque volume as measured by IVUS.
Abstract: The randomized Reduction of Restenosis In Saphenous Vein Grafts with Cypher Sirolimus-Eluting Stent trial compared angiographic outcomes of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) in saphenous vein grafts (SVG). Using intravascular ultrasound (IVUS) performed during 6-month follow-up angiography, we compared the vascular effects of the 2 types of stent on SVGs. Of 75 patients (96 lesions) included, 59 patients underwent IVUS in 61 SVGs; 29 patients received 40 SESs for 34 lesions, and 30 patients received 42 BMSs for 39 lesions. IVUS parameters (diameters, areas, and volumes) were compared in the 2 groups. A specific analysis was performed for overlapping SESs. Median neointimal volume was 1.3 mm(3) (interquartile range 0 to 13.1) in SESs versus 24.5 (7.8 to 39.5) in BMSs (p <0.001). Minimal incomplete stent apposition was detected at only 3 stent edges (2 BMSs, 1 SES) next to ectatic regions of the SVG. Compared with single SESs, overlapping SESs showed significant increases in neointimal reaction, with a neointimal volume of 0.6 mm(3)/mm of stent (0.1 to 1.8) versus 0 (0 to 0.4) in single SESs (p = 0.03), and this phenomenon was mainly localized in overlapping SES segments, where neointimal volume per millimeter of stent was 1.1 mm(3)/mm (0.6 to 4.4) versus 0 (0 to 1.3) in nonoverlapping segments (p = 0.05). In conclusion, SESs effectively inhibit neointimal hyperplasia volume compared with BMSs in diseased vein grafts, without evidence of increased incomplete apposition risk. The neointimal response to overlapping SES layers seems higher than to a single SES layer.
Abstract: A macroscopic pathological assessment of the coronary arteries of a pig's heart, in which stent implantation and intra-vascular ultrasound and thermography pullbacks were performed, shows that during percutaneous coronary catheterization and intervention, one of the major vessel traumas occurs in the very proximal part of the coronary arteries, where the guiding catheter tip is manipulated to adequately engage the vessels.
Abstract: OBJECTIVES: We sought to compare, in a randomized fashion, sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVGs). BACKGROUND: Sirolimus-eluting stents reduce restenosis and repeated revascularization in native coronary arteries compared with BMS. However, randomized data in SVG are absent. METHODS: Patients with SVG lesions were randomized to SES or BMS. All were scheduled to undergo 6-month coronary angiography. The primary end point was 6-month angiographic in-stent late lumen loss. Secondary end points included binary angiographic restenosis, neointimal volume by intravascular ultrasound and major adverse clinical events (death, myocardial infarction, target lesion, and vessel revascularization). RESULTS: A total of 75 patients with 96 lesions localized in 80 diseased SVGs were included: 38 patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. In-stent late loss was significantly reduced in SES (0.38 +/- 0.51 mm vs. 0.79 +/- 0.66 mm in BMS, p = 0.001). Binary in-stent and in-segment restenosis were reduced, 11.3% versus 30.6% (relative risk [RR] 0.37; 95% confidence interval [CI] 0.15 to 0.97, p = 0.024) and 13.6% versus 32.6% (RR 0.42; 95% CI 0.18 to 0.97, p = 0.031), respectively. Median neointimal volume was 1 mm(3) (interquartile range 0 to 13) in SES versus 24 (interquartile range 8 to 34) in BMS (p < 0.001). Target lesion and vessel revascularization rates were significantly reduced, 5.3% versus 21.6% (RR 0.24; 95% CI 0.05 to 1.0, p = 0.047) and 5.3% versus 27% (RR 0.19; 95% CI 0.05 to 0.83, p = 0.012), respectively. Death and myocardial infarction rates were not different. CONCLUSIONS: Sirolimus-eluting stents significantly reduce late loss in SVG as opposed to BMS. This is associated with a reduction in restenosis rate and repeated target lesion and vessel revascularization procedures. (The RRISC Study; http://clinicaltrials.gov/ct/show; NCT00263263).
Abstract: BACKGROUND: Antegrade femoral access is fraught by technical challenges and steeper learning curve, in comparison with retrograde contralateral femoral access. We appraised learning curve, complications, and technical aspects inherent in the adoption of antegrade approach. METHODS: Consecutive cases in which antegrade access was attempted by a cardiologist experienced in retrograde access, but inexperienced in antegrade, under supervision of an operator with anterograde expertise, were collected. The primary end-point was the occurrence of antegrade access failure or local complications. Major complications were defined as those life-threatening, requiring transfusion, percutaneous, or surgical repair. RESULTS: Anterograde access was attempted in 120 patients. The primary end-point occurred in 14 (11.6%) cases, but according to the learning curve, in 12 (20%) for first 60 cases vs 2 (3.3%) for the last 60 cases (P = 0.008). Access failure in the hands of the in-training operator was similarly found in all cases but one during the first 60 cases. No major complications occurred, while minor complications were found in 9 (7.5%) patients, again with all but two of them occurring in the first 60 cases. These included peri-adventitial extravasation in 8 patients (6.7%), and perforation of a small branch in one (0.8%); all these complications were conservatively and successfully managed. Obesity was the only significant predictor of access failure/complication (P = 0.004). CONCLUSIONS: This work, the first to report on the learning curve of the antegrade approach, supports the feasibility and safety of this access site even for an in-training operator, if supervised. A minimum caseload of 60 procedures is likely needed to master this technique.
Abstract: OBJECTIVES: This study was designed to define the current role of multislice spiral computed tomography (MSCT) for the diagnosis of coronary artery disease (CAD) using a meta-analytic process. BACKGROUND: Multislice spiral computed tomography has recently been proposed as an alternative to conventional coronary angiography (CA) for the diagnosis of CAD. METHODS: Using Medline, we identified 29 studies (2,024 patients) evaluating CAD by means of both MSCT (> or =16 slices) and conventional CA before July 2006. After data extraction the analysis was performed according to a random-effects model. RESULTS: The per-segment analysis pooled the results from 27 studies corresponding to a cumulative number of 22,798 segments. Among unassessable segments, 4.2% were excluded from the analysis and 6.4% were classified at the discretion of the investigators, underscoring the shortcomings of MSCT. With this major limitation, the per-segment sensitivity and specificity were 81% (95% confidence interval [CI] 72% to 89%) and 93% (95% CI 90% to 97%), respectively, with positive and negative likelihood ratios of 21.5 (95% CI 13.1 to 35.5) and 0.11 (95% CI 0.06 to 0.21), respectively, and positive and negative predictive values of 67.8% (95% CI 57.6% to 78.0%) and 96.5% (95% CI 94.7% to 98.3%), respectively. As expected, the per-patient analysis has shown an increased sensitivity of 96% (95% CI 94% to 98%) but a decreased specificity of 74% (95% CI 65% to 84%). CONCLUSIONS: Multislice spiral computed tomography has shortcomings difficult to overcome in daily practice and, at the more clinically relevant per-patient analysis, continues to have moderate specificity in patients with high prevalence of CAD. Studies evaluating the diagnostic performance of the newest generation of MSCT, including patients with low to moderate CAD prevalence, will be critical in establishing the clinical role of this emerging technology as an alternative to CA.
Abstract: BACKGROUND: No previous study has analyzed the possible responsibility of fellows-in-training in terms of the risk of complications during cardiac catheterization. Thus, we sought to identify possible risk factors for access site complications following cardiac catheterization procedures, with particular attention to the role of cardiology fellows. METHODS: A total of 1,288 left heart catheterization procedures (both diagnostic and interventional), performed over a 1-year period at a university hospital, were retrospectively evaluated to determine the incidence of local complications (pseudoaneurysm, arterio-venous fistula, major hematoma or bleeding, vascular dissection). Several clinical (age, gender, previous coronary artery bypass surgery, indication to the exam) and procedural (procedure performed by the fellow, access site, type of procedure, urgent setting, use of glycoprotein IIb/IIIa inhibitors, simultaneous right heart catheterization, use of closure devices) covariables were considered. Major adverse cardiovascular and cerebrovascular events (MACCE: death, myocardial infarction, cerebrovascular event) were also assessed. RESULTS: The overall access site complication rate was 2.6%. On multivariate regression analysis, the only two predictors of local complications were female gender (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.6-6.5) and femoral approach (OR 3.9, 95% CI 1.2-12.1). The rate of MACCE was 1.2%, mainly after percutaneous coronary interventions, with only 1 death overall (0.07%). Procedures performed by cardiology fellows were not associated with an increased incidence of either complication. CONCLUSIONS: Cardiology fellows can safely perform cardiac catheterization procedures without an increase in the rate of local and major cardiovascular complications. Of course, the presence and watchful supervision of an attending physician is still essential to ensure both patient safety and optimal training.
Abstract: AIMS: The role of aspirin in patients with coronary artery disease (CAD) is well established, yet patients happen to discontinue aspirin according to physician's advice or unsupervised. We thus undertook a systematic review to appraise the hazards inherent to aspirin withdrawal or non-compliance in subjects at risk for or with CAD. METHODS AND RESULTS: Electronic databases were systematically searched (updated January 2006). Study designs, patient characteristics, and outcomes were abstracted. Pooled estimates for odds ratios (OR) were computed according to random-effect methods. From the 612 screened studies, six were selected (50,279 patients). One study (31,750 patients) focused on adherence to aspirin therapy in the secondary prevention of CAD, two studies (2594) on aspirin discontinuation in acute CAD, two studies (13,706) on adherence to aspirin therapy before or shortly after coronary artery bypass grafting, and another (2229) on aspirin discontinuation among patients undergoing drug-eluting stenting. Overall, aspirin non-adherence/withdrawal was associated with three-fold higher risk of major adverse cardiac events (OR=3.14 [1.75-5.61], P=0.0001). This risk was magnified in patients with intracoronary stents, as discontinuation of antiplatelet treatment was associated with an even higher risk of adverse events (OR=89.78 [29.90-269.60]). CONCLUSION: Non-compliance or withdrawal of aspirin treatment has ominous prognostic implication in subjects with or at moderate-to-high risk for CAD. Aspirin discontinuation in such patients should be advocated only when bleeding risk clearly overwhelms that of atherothrombotic events.
Abstract: BACKGROUND: We sought to compare, using meta-analytic techniques, bare-metal stent versus balloon angioplasty in the percutaneous treatment of total coronary occlusions by means of a quantitative systematic review and to indicate new avenues for future treatments. METHODS: MEDLINE and CENTRAL were searched. Inclusion criteria were random allocation, prospective comparison, and intention to treat. Random-effect odds ratios (ORs) with 95% confidence intervals (CIs) for death, myocardial infarction (MI), repeated revascularization, major adverse cardiac events (MACE), and angiographic restenosis and reocclusion were computed. RESULTS: Nine trials (1409 patients) were included. Death rate was not different in the 2 groups, 0.4% after stenting versus 0.7% after balloon angioplasty (OR 0.72, 95% CI 0.21-2.50). MI rate was significantly increased after stenting (6.7% vs 3.4%, OR 2.06, 95% CI 1.22-3.46), mainly because of a higher rate of periprocedural non-Q-wave MI. By contrast, the risk of repeated revascularization was significantly reduced by stenting (17% vs 32%, OR 0.41, 95% CI 0.31-0.53). This yielded to an overall reduction in the rate of MACE after stenting (23.2% vs 35.4%, OR 0.49, 95% CI 0.36-0.68). Angiographic restenosis and reocclusion were also decreased by stent (41.1% vs 60.9%, OR 0.36, 95% CI 0.23-0.57; 6.8% vs 16%, OR 0.36, 95% CI 0.22-0.59, respectively). CONCLUSIONS: In total coronary occlusions, stenting yields an important benefit over balloon angioplasty in reduction of MACE, repeated revascularizations, and angiographic restenosis and reocclusion. However, these events remain frequent. Moreover, the finding of an increased rate of periprocedural minor myocardial damage after stenting casts caution. New strategies aimed to reduce the need of repeated revascularizations and periprocedural MIs should be further investigated.
Abstract: OBJECTIVES: To measure circulating levels of oxidized-low-density lipoproteins (ox-LDL) in patients with stable and unstable angina and controls, and to investigate their correlation with the extent of coronary artery disease (CAD) and the presence of complex plaques at coronary angiography. METHODS AND RESULTS: Circulating ox-LDL were assessed, using ELISA, in patients with unstable angina (UA, n=26), stable angina (SA, n=29) and in controls (C, n=27). All patients underwent coronary angiography. The extent of CAD was evaluated using a quantitative score, while the presence of complex, vulnerable plaques was angiographically assessed. Ox-LDL were higher in UA patients than in SA patients and in C subjects, and in SA patients than in C subjects (C, 45.6+/-12.8 U/L; SA, 58.8+/-11.0 U/L; UA, 73.7+/-13.6 U/L; p<0.001). No correlation was found with the extent of atherosclerotic disease in the coronary tree. Patients with angiographic complex lesions showed significantly higher levels of ox-LDL (68.4+/-13.9 U/L versus 55.2+/-16.4 U/L, p<0.001). Multiple regression analysis showed that ox-LDL were independent predictors of the presence of complex plaques (p<0.023). CONCLUSIONS: Ox-LDL levels are higher in unstable patients and correlate with the presence of angiographically documented complex plaques. Ox-LDL might be markers of destabilization of CAD.
Abstract: AIMS: Coronary dissections left untreated after percutaneous coronary intervention are associated with unfavourable outcomes. However, their role after drug-eluting stent (DES) implantation is still undescribed. We assessed incidence, predictors, and outcomes of residual dissections in DES-treated lesions. METHODS AND RESULTS: Consecutive patients undergoing DES implantation were enrolled in four Italian centres, with baseline, procedural, and outcome data entered into a dedicated database. Residual dissections were classified according to the National Heart Lung and Blood Institute criteria. End-points of interest were in-hospital, 1-month, and 6-month major adverse cardiovascular events (MACE, i.e. death, myocardial infarction, or target vessel revascularization), and stent thrombosis (ST). Among the 2418 included patients (4630 lesions), a total of 77 (1.7%) final dissections occurred in 67 (2.8%) subjects. Dissections were more frequent in longer and complex lesions and in the left anterior descending, and were associated with increased rates of in-hospital (11.9 vs. 5.2%, P=0.017) and 1-month MACE (13.4 vs. 6.0%, P=0.013), with similar 6-month trends. Cumulative ST was also greater in patients with dissections (6.3 vs. 1.3%, P=0.011). Even non-obstructive dissections with thrombolysis in myocardial infarction 3 flow conferred a significantly worse prognosis. CONCLUSION: This study, reporting for the first time on incidence, predictors, and outcomes of residual dissections in DES-treated coronary lesions, demonstrates their adverse clinical impact and supports the pursuit of a strategy of sealing dissection flaps with other DES.
Abstract: BACKGROUND: ECG-gated image acquisition of intravascular ultrasound (IVUS) has been shown to provide more accurate measurements at different phases of the cardiac cycle. OBJECTIVE: We sought to explore the ability dynamic assessment of ECG-gated 3-D IVUS to identify deformable regions of coronary plaques, by testing the hypothesis that at a given pressure and region, a faster displacement of the intima would correspond to high strain (soft tissue) regions assessed by palpography. METHODS: ECG-gated 3-D IVUS and palpograms were acquired using 30 and 20 MHz IVUS imaging catheters respectively. Frames with high and/or low strain spots identified by palpography were randomly selected and the spots were assigned to a respective quadrant within the cross section. A color-blinded side-by-side view was performed to enable the co-localization of the same region. Subsequently, the pressure driven displacement of the intima was established for each quadrant and a binary score (significant displacement or no displacement) was decided. RESULTS: One hundred and twenty-four quadrants were studied and the prevalence of highly deformable quadrants was low (n=7, 5.6% of the total). The sensitivity, specificity, positive predictive value and negative predictive value of 3-D ECG-gated IVUS to detect deformable quadrants as assessed by palpography were 42.9, 87.2, 16.7, and 96.2% respectively. CONCLUSION: In this pilot in vivo study, the intimal displacement velocity in the radial direction assessed by gray-scale 3-D ECG-gated IVUS failed to correlate with highly deformable regions. However, these preliminary findings suggest that the absence of significant displacement of the intima might be accurate to predict the absence of deformable tissue.
Abstract: OBJECTIVES: To compare long term outcomes of the crush versus the T technique in bifurcation lesions. DESIGN: 182 consecutive patients were identified who underwent percutaneous coronary interventions for bifurcation lesions with drug eluting stents between April 2002 and January 2004. Two techniques were used according to the operator's discretion: crush (group C, n = 121) or T (group T, n = 61). RESULTS: In-hospital outcome differed significantly between the two groups. Angiographic follow up was available for 142 (78%) patients. Groups C and T did not differ significantly regarding late loss (0.42 (0.39) mm v 0.34 (0.35) mm, p = 0.52) and rate of restenosis (16.2% v 13.0%, p = 0.80) in both the main and the side branch without final kissing balloon post-dilatation. However, when final kissing balloon post-dilatation was performed, group C had significantly lower late lumen loss (0.23 (0.21) mm v 0.37 (0.33) mm, p = 0.02) and restenosis rate (8.6% v 26.5%, p = 0.04) in the side branch. At one year's clinical follow up, group C compared with group T had lower rates of target lesion revascularisation (14.0% v 31.1%, p = 0.01) and target vessel revascularisation (16.5% v 32.8%, p = 0.02). CONCLUSIONS: In non-selected bifurcation lesions treated with drug eluting stents, the restenosis rate remains relatively high in the side branch. Compared with the T stenting technique, crush stenting with kissing balloon post-dilatation is associated with a reduced rate of restenosis in the side branch.
Abstract: Thienopyridines and aspirin are beneficial in patients undergoing bare-metal stent implantation, and aspirin and clopidogrel treatment have also been proved effective after drug-eluting stent (DES) implantation. However, despite the common substitution of clopidogrel with ticlopidine because of cost or patient intolerance, there are no data on the comparison of ticlopidine vs. clopidogrel after DES implantation. We hereby compare ticlopidine vs. clopidogrel after paclitaxel-eluting stent implantation in subjects enrolled in the prospective multicenter Taxus in Real-life Usage Evaluation (TRUE) Study. Across the 505 analyzed patients (112 treated with ticlopidine and 393 with clopidogrel), similar rates of early and mid-term (7 months) adverse thrombotic events were found with either antiplatelet regimen, with the notable exception of 2 cases of late stent thrombosis in patients who had prematurely withdrawn ticlopidine treatment just 3 months after the procedure. These findings thus support the overall safety and effectiveness of ticlopidine after DES implantation, and also confirm the increased risk of late thrombosis when premature withdrawal of thienopyridines occurs.
Abstract: Late luminal loss after percutaneous coronary intervention, although not normally distributed, has been shown to be monotonically correlated with the probability of binary angiographic restenosis after drug-eluting stent implantation. A recently proposed method has been shown to predict the restenosis rate after sirolimus-eluting stent and paclitaxel-eluting stent implantation using a power transformation of the value of late loss obtained after implantation of the 2 stent types. We used the same method to compute and compare restenosis rates from late loss values observed in the "head-to-head" randomized sirolimus-eluting stent versus paclitaxel-eluting stent comparisons available thus far. Our results showed that the model proposed has a poor overall ability to predict the real incidence and relative risk of restenosis because the use of late loss as an end point tended to overestimate the difference in restenosis, and the derived effect estimate of 1 stent compared with that of the other seemed to be overemphasized with respect to the real risk. We thus believe that further investigations are needed to appraise the real clinical effect of late loss and its reliability as an end point in direct comparative drug-eluting stent trials before its use can be recommended as a clinical surrogate.
Abstract: OBJECTIVE: To appraise multiple systematic reviews on the same clinical topic, focusing on predictors and correlates of quality of reporting of meta-analysis (QUOROM) scores. DESIGN: Case study. SETTING: Reviews providing at least individual quantitative estimates on role of acetylcysteine in the prevention of contrast associated nephropathy. DATA SOURCES: PubMed, the database of abstracts of reviews of effects, and the Cochrane database of systematic reviews (updated March 2005). MAIN OUTCOME MEASURES: Funding, compliance with the QUOROM checklist, scores on the Oxman and Guyatt quality index, and authors' recommendations. RESULTS: 10 systematic reviews, published August 2003 to March 2005, were included. Nine pooled events despite heterogeneity and five recommended routine use of acetylcysteine, whereas the remaining studies called for further research. Compliance with the 18 items on the QUOROM checklist was relatively high (median 16, range 11 to 17), although shorter manuscripts had significantly lower scores (R = 0.73; P = 0.016). Reviewers who reported previous not for profit funding were more likely to score higher on the Oxman and Guyatt quality index. No association was found between QUOROM and Oxman and Guyatt scores (R = -0.06; P = 0.86), mainly because of greater emphasis of the Oxman and Guyatt scores on the appraisal of bias in selection and validity assessment (inadequate in five reviews). CONCLUSIONS: Multiple systematic reviews on the same clinical topic varied in quality of reporting and recommendations. Longer manuscripts and previous not for profit funding were associated with higher quality.
Abstract: AIMS: Drug-eluting stents (DES) have been recently investigated, with favorable data for many devices, but comparative data are lacking. We thus performed an adjusted indirect comparison metaanalysis of DES. METHODS: Randomized trials comparing DES vs. bare-metal stents (BMS) were systematically searched, and random effect odds ratios (OR) were computed for target lesion revascularization (TLR) and binary in-stent restenosis rate (BRR) at 6-12 months. We then generated interaction OR for the comparison of different DES. RESULTS: We pooled data from 17 studies (allocating 3048 patients to BMS and 3392 to nine different DES). Indirect head-to-head comparison of sirolimus-eluting Cypher (N=1007) vs. polymeric paclitaxel-eluting Taxus (N=959) showed nonsignificant differences in TLR [OR=0.8 (0.5-1.4), p=0.45] but significant reductions in BRR favoring Cypher [OR=0.3 (0.1-0.6), p<0.001]. Everolimus-eluting stents appeared noninferior to Cypher or Taxus (p>0.50 for both TLR and BRR). Actinomycin-, mycophenolate-, and apolymeric paclitaxel-eluting stents (PES) all proved significantly worse than Cypher or Taxus for TLR or BRR. CONCLUSION: Notwithstanding its inherent limitations, the present metaanalysis confirms the effectiveness of both Cypher and Taxus, supports the promising role of everolimus-eluting stents, and suggests the significant inferiority of most other devices. These post hoc findings, albeit intriguing, await prospective confirmation.
Abstract: BACKGROUND: Although recent data support an early invasive management in acute coronary syndromes (ACS), overall evidence appears conflicting. We performed a metaregression to explore the impact of intracoronary stenting and aggressive antiplatelet treatment on the risk/benefit ratio of an early invasive approach. METHODS: We searched several databases up to March 2004 for randomized trials comparing an early invasive versus delayed invasive or conservative management in ACS. Random-effects odds ratios were computed for death and/or myocardial infarction at the longest follow-up. Log (odds ratios) were tested for interaction with stenting and aggressive antiplatelet treatment (ie, glycoprotein IIb/IIIa inhibitors or thienopyridines in addition to aspirin). RESULTS: Ten trials (9990 patients, median follow-up 12 months) were pooled. Overall, an early invasive management was associated with significantly reduced rates of death or myocardial infarction (P = .01). Metaregression analysis showed that the 2 most significant predictors of the benefits of an early invasive strategy in patients with ACS on event-free survival were the use, in subjects managed invasively, of aggressive antiplatelet treatment (P = .005) and stenting (P = .011). Moreover, both stenting and aggressive antiplatelet treatment were significantly associated with reduced mortality (respectively, P = .014 and P = .009) and correlated to each other (r = 0.76, P = .010). CONCLUSIONS: This study shows that the benefits of an early invasive approach in patients with ACS are significantly associated with concomitant aggressive antiplatelet treatment and stenting. These findings thus suggest the overall superiority of an early invasive approach in ACS, as long as state-of-the-art therapies are implemented.
Abstract: AIMS: To compare, by meta-analytical techniques, the clinical impact of bare-metal stenting vs. balloon angioplasty for the treatment of lesions in small coronary arteries. METHODS AND RESULTS: We included trials with random allocation and prospective comparison of angioplasty vs. stenting, reference vessel diameter<3 mm, and follow-up>or=6 months. Random effect odds ratios (OR) for death, myocardial infarction (MI), repeat revascularization (RR), and major adverse cardiac events (MACEs) were computed. In a pre-specified subgroup analysis, we compared stenting with optimal (post-procedural stenosis<20%) and suboptimal (>20%) angioplasty. Thirteen studies (4383 patients) were selected. No differences were found in terms of death and MI, while MACEs, mainly driven by RR, were significantly less common after stenting (17.6%) than after angioplasty (22.7%), OR 0.71 (0.57-0.90). Heterogeneity among trials was present. When considering only optimal angioplasty, MACE rates were homogeneously similar, 17.9 vs. 21.1%, OR 0.86 (0.66-1.11). If angioplasty were suboptimal, MACEs were significantly more common after angioplasty (24%) than after stenting (17.3%), OR 0.62 (0.44-0.88). CONCLUSION: Stenting is superior to balloon angioplasty for the treatment of small vessels, in particular after suboptimal angioplasty. However, MACE and RR rates remain high after stenting, and the advantage of stent over angioplasty is moderate. An optimal balloon angioplasty strategy (with provisional stenting) may achieve results not inferior to routine stenting.
Abstract: The aim of this study was to assess the short- and mid-term clinical impact of intravascular ultrasound guidance in 58 patients referred for elective percutaneous treatment of unprotected left main coronary artery disease with drug-eluting stents. The use of intravascular ultrasound, used in 41% of the procedures, was not associated with additional clinical benefit with respect to angiographic-assisted stent deployment.
Abstract: We compared the clinical efficacy of paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs) in a contemporary cohort of patients who had complex lesions. We collected data on 9-month outcomes in 529 patients (281 in the PES group and 248 in the SES group) whose de novo lesions were treated with drug-eluting stents. The end point was per-patient in-hospital and follow-up major adverse cardiac events, which were defined as a composite of death, myocardial infarction, and target vessel revascularization, including target lesion revascularization. There were no in-hospital deaths or repeat revascularizations; however, 5.7% of the PES group and 2% of the SES group developed a myocardial infarction (p = 0.04). At a median follow-up of 10.6 months, the rate of major adverse cardiac events was similar between groups (18.1% vs 21%, adjusted hazard ratio 0.85, 95% confidence interval 0.57 to 1.25), without any difference in the occurrence of death or myocardial infarction. Diabetes and total stent length were independent predictors of major adverse cardiac events. Propensity analysis confirmed the similarity between devices (hazard ratio 0.87, 95% confidence interval 0.62 to 1.25). Most restenoses were focal and only 2 patients required surgical revascularization. In conclusion, implantation of drug-eluting stents in complex lesions was associated with favorable results and most patients remained free from surgical revascularization at follow-up. Overall, the 2 available stent platforms had similar performance characteristics.
Abstract: Although predictors of acute intraprocedural stent thrombosis (IPST) in the drug-eluting stent era have been proposed, external validation is lacking. We thus analyzed the occurrence of IPST in the RECIPE study and found that, among 1,320 patients who underwent drug-eluting stent implantation, IPST occurred in 6 (0.5%), with in-hospital major adverse events in 4 (67%). IPST was predicted by number and total length of implanted stents, baseline minimal lumen diameter, and, in a pooled analysis that incorporated values from the present study and a previous study, use of elective glycoprotein IIb/IIIa inhibitors. Such results may provide useful information to guide prevention of this complication.
Abstract: The percutaneous treatment of patients with obstructive atherosclerotic disease in degenerated coronary saphenous vein bypass grafts still remains one of the great challenges in interventional cardiology. In this review, we discuss the actual evidence-based knowledge for the percutaneous management of this lesion subset, focusing in particular on the devices that are actually considered the "gold standard" for this treatment: bare metal stents and distal protection devices. We also comment on the negative results of the randomized trials regarding the promising polytetrafluoroethylene-covered stent-grafts. We finally offer insights into the currently available evidence for the use of drug-eluting stents in saphenous vein grafts. These devices are potentially the principal promise for the long-term successful sealing of vein graft disease; however, clear and definitive data coming from controlled trials are requested.
Abstract: OBJECTIVES: The purpose of this study was to investigate the effect of circulating levels of oxidized low-density lipoprotein (ox-LDL) on nuclear factor-kappa B (NF-kB) activation in peripheral blood mononuclear cells (PBMC) of patients with unstable angina (UA) or stable angina (SA) and control subjects. BACKGROUND: Nuclear factor-kB might be involved in atherosclerosis, as is suggested by the presence of activated NF-kB in human atherosclerotic lesions. METHODS: Levels of plasma ox-LDL and circulating NF-kB in PBMC (and in separated lymphocytes and monocytes) were measured in 27 control subjects and 29 SA and 27 UA patients. In in vitro studies, the effect of ox-LDL and of the sera derived from a subgroup of UA patients and control subjects on monocytic NF-kB activation was also evaluated. RESULTS: The UA and SA patients had higher levels of circulating ox-LDL and NF-kB in PBMC than control subjects (p < 0.001). The increase in circulating NF-kB was mainly due to the activation of monocytes. In the in vitro studies, ox-LDL dose-dependently increased the activation of NF-kB in monocytes, but not in lymphocytes derived from healthy volunteers. This increase was related to the expression of lectin-like ox-LDL receptor-1 on monocytes. The incubation of monocytes with the sera derived from the UA patients induced a significant increase in NF-kB activation compared with the sera derived from the control subjects. CONCLUSIONS: The data suggest that the activation of NF-kB in monocytes of UA patients is, at least in part, induced by circulating molecules such as ox-LDL, which has been found to be particularly elevated in UA patients.
Abstract: Intravascular ultrasound (IVUS) has provided in the last 2 decades major insights into the pathophysiology of coronary artery disease, and the mechanisms of action of percutaneous revascularization devices, helping the widespread adoption of coronary stents. The introduction of drug-eluting stents (DES) has recently lead to a revolution in the field of interventional cardiology, by virtually eliminating restenosis in selected low-risk lesions and significantly reducing both restenosis and repeat revascularizations in higher risk lesions. At the moment, the role of IVUS in the DES era is not well defined. Clinical studies utilizing IVUS in DES implantation used this technology mainly to evaluate the endpoint of intimal hyperplasia and to study the problem of incomplete apposition. On a theoretical basis, a method able to better evaluate optimal placement of a local drug delivery system should have a high rationale. Despite this sound preamble, no specific investigation has been conducted to evaluate the clinical need and possible advantage of routine IVUS for DES implantation and uncertainty is still present. A major hindrance lays in the low incidence of restenosis in most randomized trials enrolling few selected lesions per patient, as this fact enlarges the number of patients who need to be treated to demonstrate a benefit and casts doubts on the cost effectiveness of a more expensive and time consuming approach. The situation is bound to change when more complex patients and lesions are being treated, a setting associated with a higher event rate even when DES are used. While waiting for a prospective study addressing such issue, we can only rely on indirect evidence to justify and support the usage of IVUS in complex clinical settings with implantation of DES.
Abstract: A 19 year old pregnant woman presented to the coronary care unit with an acute anterior myocardial infarction. She was treated with primary percutaneous transluminal coronary angioplasty of the proximal left anterior descending coronary artery. Ultrasound examination showed patent foramen ovale (PFO) and atrial septal aneurysm. The patient was a heterozygote carrier of factor V Leiden. Despite the lack of a clear clue, it was considered that the pathophysiological cause of this infarction was a paradoxical embolus in the left coronary artery. Pregnancy and factor V Leiden carriership are associated with increased risk of venous thromboembolism and the association between PFO and atrial septal aneurysm is a strong risk factor for systemic embolisation.
Abstract: AIM: Clopidogrel is an established alternative to ticlopidine in addition to aspirin after coronary stenting because of its hematologic safety, but its efficacy in comparison to ticlopidine is debated. We thus systematically reviewed randomized trials comparing clopidogrel vs ticlopidine after coronary stenting. METHODS: Medline (1/1986-10/2003), BioMed Central, Central, Current Contents, LILACS and mRCT were searched. Fixed-effect relative risks (RR [95% CI]) were computed, and the primary end-point was death. Heterogeneity tests and subgroup analyses were performed according to loading vs non-loading clopidogrel scheme. RESULTS: Five trials were retrieved (2 962 patients, average follow-up 7.4 months). In 3 studies both clopidogrel and ticlopidine were started with a loading dose, in 1 trial clopidogrel was administered without loading, and in 1 trial clopidogrel could be administered with or without loading. Overall analysis (p for heterogeneity=0.12) showed a non-significant trend toward increased mortality in patients treated with clopidogrel (38/1 649 [2.3%]) vs ticlopidine (22/1 313 [1.7%], RR=1.64 [0.94-2.86], p=0.080). After stratification, clopidogrel with loading was associated with non-significantly lower mortality rates than ticlopidine (9/959 [0.9%] vs 13/798 [1.6%], RR=0.68 [0.29-1.63], p=0.39). Instead, clopidogrel without any loading yielded a highly significantly 3-fold increased risk of death than ticlopidine (29/690 [4.2%] vs 9/515 [1.7%], RR=2.9 [1.45-6.1], p=0.0029). Similar results were obtained for the rate of death or non-fatal myocardial infarction. CONCLUSION: This meta-analysis suggests that clopidogrel treatment including a loading regimen is equivalent or may even be superior to ticlopidine after coronary stenting. However, current evidence shows conversely that clopidogrel therapy in the absence of a loading dose is associated with a significantly higher risk of death or myocardial infarction.
Abstract: OBJECTIVES: We sought to compare, through a meta-analytic process, the transradial and transfemoral approaches for coronary procedures in terms of clinical and procedural outcomes. BACKGROUND: The radial approach has been increasingly used as an alternative to femoral access. Several trials have compared these two approaches, with inconclusive results. METHODS: The MEDLINE, CENTRAL, and conference proceedings from major cardiologic associations were searched. Random-effect odds ratios (ORs) for failure of the procedure (crossover to different entry site or impossibility to perform the planned procedure), entry site complications (major hematoma, vascular surgery, or arteriovenous fistula), and major adverse cardiovascular events (MACE), defined as death, myocardial infarction, emergency revascularization, or stroke, were computed. RESULTS: Twelve randomized trials (n = 3,224) were included in the analysis. The risk of MACE was similar for the radial versus femoral approach (OR 0.92, 95% confidence interval [CI] 0.57 to 1.48; p = 0.7). Instead, radial access was associated with a significantly lower rate of entry site complications (OR 0.20, 95% CI 0.09 to 0.42; p < 0.0001), even if at the price of a higher rate of procedural failure (OR 3.30, 95% CI 1.63 to 6.71; p < 0.001). CONCLUSIONS: The radial approach for coronary procedures appears as a safe alternative to femoral access. Moreover, radial access virtually eliminates local vascular complications, thanks to a time-sparing hemostasis technique. However, gaining radial access requires higher technical skills, thus yielding an overall lower success rate. Nonetheless, a clear ongoing trend toward equalization of the two procedures, in terms of procedural success, is evident through the years, probably due to technologic progress of materials and increased operator experience.
Abstract: Vasopressin is currently recommended in the management of patients with cardiac arrest, but its efficacy is still incompletely established. We systematically reviewed randomized trials comparing vasopressin to control treatment in the management of cardiac arrest in humans and animals. Two human and 33 animal studies were retrieved. At pooled analysis vasopressin appeared equivalent to adrenaline (epinephrine) in the management of human cardiac arrest (N=240), with, respectively 63 (78/124) vs 59% (68/116) ROSC (P=0.43), and 16 (20/124) vs 14% (16/116) survival to hospital discharge (P=0.52). In animal trials (N=669) vasopressin appeared instead significantly superior to both placebo (ROSC, respectively 93 [98/105] vs 19% [14/72], P<0.001) or adrenaline (ROSC, respectively 84 [225/268] vs 52% [117/224], P<0.001). In conclusion, vasopressin is superior to both placebo or adrenaline in animal models of cardiopulmonary resuscitation. Evidence in humans is still limited and confidence intervals estimates too wide to reliably confirm or disprove results obtained in experimental animal settings.
Abstract: BACKGROUND: Coronary angioplasty and coronary artery bypass grafting (CABG) are both major techniques for the management of coronary artery disease, but CABG is associated with a lower incidence of repeat revascularization. Recent studies comparing angioplasty with stenting vs CABG have yielded conflicting results, with some suggesting improved survival with stenting, and others the opposite. We thus undertook a systematic overview of the randomized trials comparing stenting vs CABG in coronary artery disease. METHODS: MEDLINE (January 1986-February 2003), ISI Current Contents, the Cochrane Controlled Trial Register, LILACS and the American Heart Association, American College of Cardiology, European Society of Cardiology, and Transcatheter Cardiovascular Therapeutics conference proceedings were among the databases we searched. Abstraction was performed in a non-blinded manner on pre-specified forms. The random-effect odds ratios for death, myocardial infarction, stroke, repeat revascularization, and symptomatic angina were computed for the longest available follow-up. RESULTS: Nine randomized trials (3283 patients, representing only 6% of all screened subjects) with an average follow-up of 28 months were included in the analysis, while four studies were excluded because they were still unpublished, ongoing, or with non-systematic stenting. No study used drug-eluting stents. The odds ratios for stenting vs CABG were 0.82 (95% confidence interval-CI 0.57-1.18, p = 0.3) for the occurrence of death, non-fatal myocardial infarction or stroke, 4.6 (95% CI 3.5-5.9, p < 0.00001) for repeat revascularization, and 2.3 (95% CI 1.8-2.8, p < 0.00001) for symptomatic angina. Heterogeneity tests were not statistically significant. The results of sensitivity analysis were similar even after stratification for single vessel, off-pump, single center or high-quality studies. CONCLUSIONS: Overall and event-free survival after conventional stenting for coronary artery disease are similar to those after CABG, but surgery is still associated with a significantly lower incidence of repeat revascularization and symptoms. The role of next-generation drug-eluting stents in widening the indications for stenting and overcoming restenosis will need to be assessed in future observational and randomized studies comparing stenting vs CABG.
