Abstract: Despite the impressive benefits obtained following the introduction of the drug-eluting stent, safety concerns have been raised over their long-term safety with particular regard to stent thrombosis. Various mechanisms such as delayed endothelialization, local hypersensitivity and endothelial dysfunction owing to the durable polymer coating and/or the drug itself have been suggested as possible causes of this phenomenon. Therefore, to address these concerns, a newer-generation of drug-eluting stents has been developed and they are currently undergoing preclinical and clinical evaluation in order to increase both the safety and biocompatibility by optimizing the three major components of drug-eluting stents: the stent platform, the polymer and the drug. This article critically reviews the key clinical trials and the current status of these new coronary devices as well as preventing future perspectives for their continued development.
Abstract: This study sought to evaluate the long-term angiographic and clinical outcomes after the treatment of drug-eluting stent in-stent restenosis (DES-ISR) based on the angiographic pattern of restenosis.
Abstract: The aim of this study was to evaluate the incidence, predictors, management, and clinical outcomes in patients with grade III coronary perforation during percutaneous coronary intervention.
Abstract: Iatrogenic occlusive coronary dissection (IOCD) is a rare but high-risk complication of percutaneous coronary intervention (PCI) with limited data on options for management. The aim of this study was to describe a novel approach to the treatment of IOCD in order to gain access to the true coronary lumen. This technique may be feasible in cases in which conventional methods of PCI have failed.
Abstract: A 38-year-old-female presented to our unit for investigation of an incidental diagnosis of right ventricular dilatation. Transthoracic colour Doppler echocardiography demonstrated an anomalous flow into the inferior vena cava. The suspicion of partial anomalous venous drainage was supported by the finding of a scimitar sign on chest X-ray. Left and right heart catheterization demonstrated a significant left-to-right shunt (Qp/Qs = 2.22) with a step-up in oxygen saturation from the inferior vena cava (IVC) to lower right atrium. Selective angiography confirmed drainage of an anomalous pulmonary vein to the IVC-atrial junction. Scimitar syndrome is a rare vascular anomaly that can manifest in childhood with signs of right heart failure and/or recurrent pneumonia. When asymptomatic, this anomaly can be accidentally discovered in adulthood and should be suspected in cases of left-to-right shunt without evidence of obvious cardiac structural defects.
Abstract: Subintimal angioplasty (SAP) is frequently performed for the treatment of critical limb ischemia (CLI) and has been recognized as an effective technique for these patients. Nevertheless, this approach is limited by the lack of controlled re-entry into the true lumen of the target vessel. We describe a novel device for true lumen re-entry after subintimal recanalization of superficial femoral arteries (SFA). We report our experience with six patients treated between April 2009 and January 2010 with a novel system designed to facilitate true lumen re-entry. The device was advanced by ipsilateral antegrade approach through a 6-French sheath. Successful reaccess into the true lumen was obtained in five of six patients without complications. The patient in whom the reaccess to the true lumen was not possible underwent successful bypass surgery. At 30Â days follow-up, the SFA was patent in all patients according to echo-Doppler examination. Our preliminary experience indicates that this novel re-entry device increases the success rate of percutaneous revascularization of chronically occluded SFA.
Abstract: The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California).
Abstract: Rapid right ventricular pacing (RRVP) at rates above 200 beats/minute is used to suppress cardiac output during balloon aortic valvuloplasty (BAV) in transcatheter aortic valve replacement (TAVI) patients. A risk of inducing myocardial ischemia with RRVP remains, especially in patients with left ventricular dysfunction. Alternatively, a transient cardiac arrest can be achieved with administration of adenosine.
Abstract: Stent thrombosis (ST) and restenosis are concerns after percutaneous coronary intervention (PCI). Limited information exists concerning clinical and angiographic outcomes following multiple stent insertion. We therefore present the long-term outcome from drug-eluting stent (DES) insertion and correlate this with the Syntax score.
Abstract: In the field of interventional cardiology, transcatheter aortic valve implantation is the newest and most exciting development of recent years. With a growing evidence base for both prognostic and symptomatic benefit, more and more interventionalists are keen to learn the procedure. However, the concomitant risk associated with a technically challenging procedure in a high-risk patient population is significant, and complications can arise suddenly and often unexpectedly. It is essential that new, and even established, operators are meticulously aware of the potential for complications, are able to identify them at an early stage, and manage them quickly and effectively. We have significant experience with transcatheter aortic valve implantation, through the implantation of 260 devices, which brings first-hand experience of most major complications. This article provides insight into the potential for complications, offering advice on effective treatment, recognition, and ultimately, prevention. It also suggests a number of procedural and technical modifications, which might improve outcomes in the future.
Abstract: BACKGROUND: Dual antiplatelet therapy (DAT, i.e. aspirin+thienopyridine) has been shown to reduce the risk of stent thrombosis (ST) and myocardial infarction (MI) after coronary stent implantation. Data regarding alternative antiplatelet therapy in patients with allergy or intolerance to aspirin are lacking. METHODS: This study is a retrospective analysis of consecutive patients with adverse reactions to aspirin who received an alternative combination of DAT (indobufen, trapidil, or triflusal in association with a thienopyridine) after elective implantation of either drug-eluting (DES) or bare-metal stents (BMS). Endpoints analyzed were cardiac death, MI, ST and bleeding. RESULTS: A total of 127 patients undergoing stenting of 267 lesions (DES 84%, BMS 16%), were identified between June'99 and November'08. Reasons for not taking aspirin included gastrointestinal intolerance (53.5%), allergy (39.4%), non-gastrointestinal bleeding (5.5%) and others (1.6%). Aspirin was substituted with indobufen (64.6%), trapidil (26.8%), triflusal (6.3%), or a combination of indobufen+trapidil (2.4%). Median duration of DAT was 369days [IQR 273-1053] after DES and 46.5days [IQR 30-699] after BMS implantation. Only 3.1% of patients prematurely discontinued DAT. During a median follow-up of 1161days [IQR 781-1538], rates of cardiac death and MI were 3.1% and minor bleeding occurred in 1.5%. There was 1 very late definite ST occurring 2days after DAT discontinuation and no probable ST. CONCLUSIONS: In this cohort of patients with aspirin intolerance undergoing coronary stent implantation, the combination of a thienopyridine with indobufen, trapidil, or triflusal was associated with a low rate of cardiac death, ST and MI.
Abstract: To investigate the predictors of moderate-to-severe aortic regurgitation (AR≥2+) after CoreValve implantation and evaluate the feasibility and safety of postdilatation in reducing the degree of AR.
Abstract: Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates.
Abstract: To assess outcomes after transcatheter aortic valve implantation (TAVI) according to sex, with the two available valves and four recognised delivery approaches.
Abstract: Alternative percutaneous approaches to the management of symptomatic aortic stenosis in elderly and high-risk patients have become more attractive and raised profound interest in recent years. The superiority of transcatheter aortic valve implantation (TAVI) compared with medical therapy for patients deemed unsuitable for surgery has recently been established by the PARTNER trial, and preliminary randomized data in high-risk patients have confirmed that TAVI is non-inferior to surgical valve replacement in terms of safety and effectiveness. This finding will probably lead to an exponential increase in TAVI procedures over the next decade. In the clinical setting of the percutaneous approach, the choice of a specific valve is crucial to optimize the success rate and minimize the procedure-related complications and requires accurate preprocedural diagnostic assessment. According to the high comorbidities of candidates currently undergoing a TAVI procedure, a tailored diagnostic framework in the elderly population is highly recommended. The present review discusses the role of echocardiography in the setting of multimodality imaging before the TAVI procedure and throughout the entire process, from patient selection to procedural guidance and post-procedural follow-up, suggesting a practical algorithm necessary for the best clinical outcome.
Abstract: AIMS: Limited data are available on the long-term outcome following PCI with paclitaxel-eluting stent (PES) implantation in patients with unprotected left main coronary artery (LMCA). The objective of this study was to evaluate "real world" long-term outcome following paclitaxel-eluting stent (PES) implantation for unprotected LMCA disease in patients enrolled in the TRUE registry. METHODS AND RESULTS: From March 2003 to October 2004, 93 consecutive patients (81.7% male) underwent PCI for unprotected LMCA disease. Surveillance angiography was performed at 6.8+/-3.3 months follow-up. The target lesion involved the distal LMCA in 68 (73.1%) patients. Double stenting techniques were performed in 46 (67.6%) distal LMCA, of these 50% were stented using the Crush technique. Clinical follow-up was complete in all patients with 85.8% angiographic follow-up rate. In-segment restenosis occurred in 16 (20.3%) patients and was focal in 72.4% of cases and significantly higher in patients with distal LMCA (36.8% vs. 13.6%, p<0.04). At a median follow-up of 1,450 days (IQR 1281-1595), the overall incidence of MACE was 35.5% and the TLR rate was 25.8% and significantly higher in patients with bifurcation stenting (32.3% vs. 8%, p<0.02). The estimated cardiac survival rate at one and four years was 96.7% and 93.3%, respectively. Total mortality rate was 14.1% and cardiac was 6.5%. There was one (1.1%) definite stent thrombosis (ST) and one (1.1%) probable ST. CONCLUSIONS: Treatment of unprotected LMCA disease with PES, after four years follow-up, appears to be safe and effective with a low rate of cardiac mortality and overall risk of ST. The need for target lesion revascularisation in 25.8% of patients highlights the need for more effective PCI especially in patients with distal LMCA disease.
Abstract: OBJECTIVES: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. BACKGROUND: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. METHODS: Fifty-two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards-Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. RESULTS: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards-Sapien) or one (CoreValve). There were serious "on-table" complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure-iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. CONCLUSION: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites.
Abstract: PURPOSE: To evaluate clinical outcomes in patients undergoing carotid artery stenting (CAS) with routine use of a cerebral embolic protection device (EPD). METHODS: A retrospective cohort analysis was conducted of 490 consecutive patients (365 men; mean age 70.7+/-8.5 years) who underwent CAS with EPD between January 1999 and December 2007 at 2 institutions with large referral practices. There were 163 symptomatic patients with stenosis >or=50% and 327 asymptomatic patients with >or=80% diameter stenosis treated in 536 CAS procedures. Nearly a quarter (116, 23.7%) of the cohort had diabetes. High-risk surgical features were present in 141 (28.8%): 73 (14.9%) aged >or=80 years, 25 (5.1%) with significant heart disease, 23 (4.6%) with postsurgical restenosis, and 16 (3.2%) with contralateral carotid occlusion. An EPD was successfully placed in 512 (95.5%) patients. RESULTS: The incidence of any stroke within 30 days was 3.3% (16/490), of which the majority (13, 2.6%) were ipsilateral [5 (1.0%) major and 8 (1.6%) minor]. The incidence of major adverse events (MAE), i.e., any stroke, death or myocardial infarction, within 30 days was 3.7% (18/490); the incidence of 30-day any stroke/death was 3.7% (18/490), while the cumulative incidence of any stroke/death at 1 year was 6.1% (30/490). In symptomatic patients, the 30-day MAE rate was 6.7% (11/163) versus 2.1% (7/237) in the asymptomatic group (p = 0.02). A subgroup analysis based on surgical risk showed that the 30-day MAE rate was similar between high-risk and non-high-risk patients [4.9% (7/144) versus 3.2% (11/346); p = 0.5]. CONCLUSION: In this large real-world cohort, CAS with routine use of EPDs was technically feasible, clinically safe, and associated with a low rate of periprocedural and 1-year events; results were similar irrespective of surgical risk.
Abstract: Diabetes mellitus (DM) accounts for >25% of all percutaneous coronary interventions. In patients with DM, drug-eluting stent implantation is associated with a reduced risk of restenosis and target lesion revascularization. However, concern has been raised about the incidence of late and very late stent thrombosis and the increased mortality rate, mostly after thienopyridine withdrawal. We evaluated the long-term prognostic effect of thienopyridine discontinuation after drug-eluting stent implantation on the subsequent occurrence of stent thrombosis and all-cause death among a cohort of high-risk "de novo" diabetic patients. From May 2002 to December 2005, 542 consecutive patients with DM underwent drug-eluting stent implantation at 2 hospitals in Milan, Italy. For study purposes, only the 217 patients who had not previously undergone percutaneous or surgical revascularization were considered in the final analysis. The follow-up time was curtailed at 3.5 years. Detailed information about dual antiplatelet therapy (DAT) were collected for all patients included. Of the 217 patients, 15 died (6.9%); in 9 cases, the cause of death was cardiac (4.1%). The incidence of cumulative stent thrombosis was 4.6% (10 patients); 3 stent thromboses were early (1.38%), 5 late (2.3%), and only 2 were very late (0.9%). Of the 10 cases of stent thrombosis, 5 were definite and 5 were probable. Most (80%) of the stent thromboses occurred within the first 6 months during DAT. The median duration of DAT was 420 days (interquartile range 350 to 859). DAT discontinuation was the only independent predictor of the follow-up events (hazard ratio 20.42, 95% confidence interval 4.99 to 83.62). In conclusion, DM remains an independent adverse factor on clinical outcome. In this setting, prolonged DAT, even beyond that recommended in the guidelines, might be beneficial.
Abstract: BACKGROUND: Concerns about the long-term safety of drug-eluting stents (DES) in saphenous vein grafts has become an area of controversy and uncertainty. METHODS AND RESULTS: In this retrospective registry, we compared the outcomes in 127 patients (143 lesions) treated with DES from April 2002 to June 2006 (DES group) with 131 patients (160 lesions) treated with bare-metal stents in the preceding 36 months (bare-metal stent group). End points analyzed were cumulative death, myocardial infarction, and target vessel revascularization at 2 years after stent implantation. The DES group was significantly (P<0.05) more complex with a greater frequency of diabetes (33.1%versus 15.3%), older grafts (11.6+/-5.3 years versus 9.6+/-5.2 years), restenotic lesions (23.8% versus 4.4%), total occlusions (7.7% versus 1.2%), and smaller grafts (3.16+/-0.66 mm versus 3.44+/-0.76 mm) treated with longer stents (34.1+/-25.1 mm versus 22.7+/-11.6 mm). At 2 years, there was no statistical difference in death (8.7% versus 7.8%), myocardial infarction (6.3% versus 9.4%), or target vessel revascularization (19.7% versus 24.2%) between DES and bare-metal stents, respectively. A propensity analysis to adjust for baseline differences suggested that there was no observed association between DES and increased mortality (hazard ratio, 0.72; 95% CI, 0.21 to 2.44; P=0.60) but possibly an association with a reduction in target vessel revascularization (hazard ratio, 0.31; 95% CI, 0.14 to 0.66; P=0.002). CONCLUSIONS: Despite being implanted in patients and lesions more complex than the bare-metal stent group, there was no observed association between DES implantation in saphenous vein grafts and an increase in late mortality. DES may maintain their efficacy in reducing revascularization rates in diseased saphenous vein grafts over a 2-year follow-up period.
Abstract: Poor long-term outcomes after percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) of saphenous vein grafts (SVGs) have been reported. However, limited data are available evaluating the use of modern techniques in this group. The aim of the present study was to assess the efficacy and long-term outcomes of PCI in SVG CTO with the routine use of embolic protection devices and drug-eluting stents. A retrospective cohort analysis was conducted of all consecutive patients undergoing PCI to SVG CTO from May 2002 to July 2009 at 2 centers. The indication for PCI was the presence of angina or silent ischemia with evidence of inducible ischemia after functional testing in the territory supplied by the SVG, despite optimal medical therapy. We identified 34 patients with SVG CTO. Of the 34 patients, 23 (68%) underwent successful SVG recanalization with stent implantation. An embolic protection device was used in 78% and 95% of stents implanted were drug-eluting stents. No in-hospital major adverse cardiac events occurred in the successful PCI group; one myocardial infarction occurred in the unsuccessful group. At follow-up (median 18.0 months, interquartile range 10.4 to 48.3), 1 case of myocardial infarction had occurred in the successful group. The in-stent restenosis rate was 68% (n = 13), of which 77% were focal, with target vessel revascularization in 61%. In conclusion, despite the relatively low procedural success rates, the clinical outcomes after successful PCI to SVG CTO with modern techniques were favorable. The repeat revascularization rates were high; however, graft patency was achievable in most after reintervention.
Abstract: Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion.
Abstract: OBJECTIVES: We sought to evaluate at 5 years the occurrence of cardiac death; cardiac death, and/or myocardial infarction (MI); cardiac death, MI, and/or stroke; target vessel revascularization; and major adverse cardiac and cerebrovascular events following percutaneous coronary intervention (PCI) with drug-eluting stent (DES) versus coronary artery bypass graft (CABG) in unprotected left main coronary artery lesions. BACKGROUND: Preliminary results at 1 year showed comparable occurrence of major adverse cardiac and cerebrovascular events in our center between PCI and CABG. METHODS: All consecutive patients with an unprotected left main coronary artery stenosis electively treated with DES implantation versus CABG in our center, between March 2002 and July 2004, were analyzed. A propensity analysis was performed to adjust for baseline differences between the 2 cohorts. RESULTS: We included 249 patients in the study: 107 were treated with PCI and DES implantation and 142 with CABG. At 5-year clinical follow-up, no difference was found between PCI and CABG in the occurrence of cardiac death (adjusted odds ratio [OR]: 0.502; 95% confidence interval [CI]: 0.162 to 1.461; p = 0.24). The PCI group showed a trend toward a lower occurrence of the composite end point of cardiac death and MI (adjusted OR: 0.408; 95% CI: 0.146 to 1.061; p = 0.06). Percutaneous coronary intervention was associated with a lower rate of the composite end point of death, MI, and/or stroke (OR: 0.399; 95% CI: 0.151 to 0.989; p = 0.04). Indeed, CABG was correlated with lower target vessel revascularization (adjusted OR: 4.411; 95% CI: 1.825 to 11.371; p = 0.0004). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular events (adjusted OR: 1.578; 95% CI: 0.825 to 3.054; p = 0.18). CONCLUSIONS: At 5-year clinical follow-up, there was still no difference in the occurrence of major adverse cardiac and cerebrovascular events between elective PCI with DES implantation and CABG in unprotected left main coronary artery lesions in this single-center experience. There was an advantage of PCI in the composite end point of death, MI, and/or stroke, whereas a benefit in the need for reintervention was still found in CABG.
Abstract: Previous data showed that recanalization of chronic total occlusions (CTO) with the subintimal tracking and reentry (STAR) technique is feasible. However, this technique is challenging and requires skilled operators to be performed. The aim of this study was to evaluate procedural and clinical outcomes of patients undergoing a contrast-guided STAR procedure.
Abstract: Investigation of the correlation between bifurcation angles and outcomes is limited with discordant results. The aim of this study is to investigate left main (LM) and non-left main (N-LM) bifurcation angles and their modification after percutaneous coronary intervention (PCI). Measurement of all three angles adds to our understanding of bifurcation anatomy and the resultant effect of different stenting techniques.
Abstract: OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of unrestricted everolimus-eluting stent (EES) implantation in a contemporary cohort of real-world patients. BACKGROUND: The randomized SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials have evaluated the performance of EES, resulting in their approval by the Food and Drug Administration, but data regarding unselected usage, including off-label indications are lacking. METHODS: Consecutive patients treated with EES (either PROMUS, Boston Scientific Corp., Natick, Massachusetts, or XIENCE-V, Abbott Vascular Devices, Santa Clara, California) between October 2006 and February 2008 were analyzed. End points were cardiac death, myocardial infarction (MI), ischemic-driven target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac events (MACE) (a composite of cardiac death, MI, TLR) during follow-up. RESULTS: We identified 345 patients (573 lesions) treated with EES. The majority of patients (71.9%) were treated for > or =1 off-label or untested indication. Clinical follow-up was completed in 99%. At a median follow-up of 378 days (interquartile range 334 to 473), MACE occurred in 36 (10.6%) patients, TLR in 27 (7.9%), MI in 7 (2.1%), and cardiac death in 7 (2.1%). Definite and probable ST was observed in 3 (0.9%) cases. Off-label EES implantation was not associated with a statistically significant increased risk of MACE (12.2% vs. 6.3%, p = 0.17), TLR (9.3% vs. 4.2%, p = 0.18), or ST (0.8% vs. 1.1%, p = 1.0). On multivariable analysis, previous bypass surgery (p = 0.002) and diabetes (p = 0.03) were associated with MACE. CONCLUSIONS: In unrestricted daily practice, EES were implanted predominantly for off-label indications and associated with a relative low rate of MACE and TLR.
Abstract: To characterize in-stent restenosis after the implantation of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), tacrolimus-eluting stents (TES), and zotarolimus-eluting stents (ZES), 25 patients treated with drug-eluting stents (DES; 9 PES, 10 SES, 4 TES, and 2 ZES) and 19 with bare-metal stents (BMS) underwent directional coronary atherectomy for in-stent restenosis 4 to 36 months after implantation. Restenosis after DES implantation was more frequently focal and associated with smaller specimens compared to that after BMS implantation. Light and confocal microscopy were used. Histologic features were similar in DES and BMS. In-stent restenotic lesions were composed mainly of neointima containing proteoglycan-rich smooth muscle cells and fibrolipidic regions. Small inflammatory infiltrates were observed, mostly in patients with unstable angina; CD18- and/or CD3(+) cells were detected in patients with BMS and DES. Different smooth muscle cell phenotypes were observed: synthetic was more frequent with BMS and PES, intermediate with ZES, contractile or intermediate with SES, and contractile with TES. The mean proliferation index was low and comparable among stent types; cyclins B1 and D1 were expressed in all DES. In conclusion, intra-DES and intra-BMS restenotic tissue was composed mainly of smooth muscle cells with different phenotypes, proliferating at a low rate. The different smooth muscle cell phenotypes within the stent types might suggest different mechanisms of restenosis.
Abstract: Little is known about arrhythmogenic right ventricular cardiomyopathy (ARVC) in Africa. The objective of this study was to delineate the clinical characteristics, survival, and genetics of ARVC in South Africa. Information on clinical presentation, electrocardiographic and cardiac imaging findings, histology, and outcome of cases with suspected ARVC was collected using the standardised form of the ARVC Registry of South Africa. Genomic DNA was screened for mutations in plakophylin-2 (PKP2) gene. Survival and its predictors were analyzed using the Kaplan-Meier and Cox proportional hazards regression methods, respectively. Fifty unrelated cases who met the diagnostic criteria for ARVC were enrolled between January 2004 and April 2009. Clinical presentation was similar to that reported in other studies. Annual mortality rate was 2.82%, five-year cumulative mortality rate 10%, and mean age at death 36.9 +/- 14.7 years. Overall survival was similar to the general South African population (P = 0.25). Independent risk factors for death were syncope (Hazard Ratio [HR] 10.73, 95% Confidence Interval [CI] 1.88-61.18, P = 0.008) and sustained ventricular tachycardia (HR = 22.97, 95%CI 2.33-226.18, P = 0.007). Seven PKP2 gene mutations were found in 9/36 (25%) unrelated participants, five being novel. The novel C1162T mutation occurred in four white South Africans sharing a common haplotype, suggesting a founder effect. Compound heterozygotes exhibited a severe phenotype signifying an allele dose effect. ARVC is associated with early mortality that is no different to the general South Africa population whose lifespan is shortened by HIV/AIDS. PKP2 gene mutations are common, have an allele dose effect, and a novel founder effect in white South Africans.
Abstract: BACKGROUND: Limited long-term data exist on patients who have undergone drug-eluting stenting of very long lesions (requiring >or=60 mm of continuous stent) in native coronary arteries ("full-metal jacket"). METHODS AND RESULTS: We examined consecutive procedures taking place between March 2002 and 2007 at 2 high-volume centers in Milan, Italy. Exclusion criteria were percutaneous coronary intervention for restenosis, percutaneous coronary intervention to a bypass graft, or percutaneous coronary intervention for acute ST-elevation myocardial infarction (MI). We identified 658 full-metal jacket lesions in 617 patients. Average age of the cohort was 62.0+/-10.6; 32.8% were diabetic, 51.5% had a previous MI, and 33.4% had undergone a previous percutaneous transluminal coronary angioplasty. Mean ejection fraction was 52.1+/-10.4%. The lesion was a chronic total occlusion in 33.0%. Median duration of clinical follow-up was 39 months (interquartile range, 28 to 50). Six-month follow-up was achieved in 97% of patients; 2-year follow-up was achieved in 91%. All-cause mortality rate was 7.3%; cardiac death rate was 3.6%. Non-procedure-related MI rates were 3.5%. Target lesion revascularization rates were 23.4%. There were 17 cases of Academic Research Consortium-defined definite or probable stent thrombosis (2.6%): 5 acute, 2 subacute, 6 late, and 4 very late. Ten of the 17 cases occurred while the patient was receiving dual antiplatelet therapy; 4 of the 17 after premature termination of 1 or both antiplatelets, and 3 of the 17 occurred while the patient was receiving single-antiplatelet therapy, after having completed the prescribed course of dual antiplatelet therapy. CONCLUSIONS: When very long lesions (>or=60 mm) were treated using overlapping drug-eluting stents, 23.4% required a further procedure for restenosis at 3-year follow-up. However, MI, stent thrombosis, and cardiac mortality rates were relatively low.
Abstract: The use of intravascular ultrasound (IVUS) to improve acute angiographic results was already shown in the prestent era. Various studies demonstrated the efficacy of IVUS in balloon sizing and estimating the extent of positive remodeling. With the introduction of drug-eluting stents (DES) the rate of restenosis has been significantly reduced but a new concern, the risk of stent thrombosis, has emerged. The association of stent underexpansion with stent thrombosis was observed for bare metal stents (BMS) and DES. Until now, the criteria for IVUS optimization used in different studies have relied on distal reference or on mean reference vessel for stent or postdilatation balloon sizing. Furthermore, an important recent innovation not available in previous studies is the use of noncompliant balloons to perform high pressure post-dilatation. Universal and easily applicable IVUS criteria for optimization of stent implantation as well as randomized studies on IVUS-guided DES implantation are necessary to minimize stent malapposition and underexpansion, which in turn can positively influence the rates of stent restenosis and thrombosis.
Abstract: ABSTRACT: BACKGROUND: Dual anti-platelet therapy with aspirin and a thienopyridine (DAT) is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Low response to clopidogrel therapy (LR) occurs, but laboratory tests have a controversial role in the identification of this condition. METHODS: We studied LR in patients with stable angina undergoing elective PCI, all on DAT for at least 7 days, by comparing: 1) Flow-cytometry (FC) to measure platelet membrane expression of P-selectin (CD62P) and PAC-1 binding following double stimulation with ADP and collagen type I either in the presence or absence of prostaglandin (PG) E1; 2) VerifyNow-P2Y12 test, in which results are reported as absolute P2Y12-Reaction-Units (PRU) or % of inhibition (% inhibition). RESULTS: Thirty controls and 52 patients were analyzed. The median percentage of platelets exhibiting CD62P expression and PAC-1 binding by FC evaluation after stimulation in the presence of PG E1 was 25.4% (IQR: 21.4-33.1%) and 3.5% (1.7-9.4%), respectively. Only 6 patients receiving DAT (11.5%) had both values above the 1st quartile of controls, and were defined as LR. Evaluation of the same patients with the VerifyNow-P2Y12test revealed that the area under the receiver-operating-characteristic (ROC) curve was 0.94 (95% CI: 0.84-0.98, p < 0.0001) for % inhibition and 0.85 (0.72-0.93, p < 0.005) for PRU. Cut-off values of [less than or equal to] 15% inhibition or > 213 PRU gave the maximum accuracy for the detection of patients defined as having LR by FC. CONCLUSIONS: In conclusion our findings show that a cut-off value of [less than or equal to] 15% inhibition in the VerifyNow-P2Y12test may provide the best accuracy for the identification of patients with LR.
Abstract: OBJECTIVES: Preliminary Investigation to the Angiographic Versus IVUS Optimization Trial is a single center prospective observational intravascular ultrasound (IVUS) guided stent implantation study assessing new criteria for optimal drug eluting stent (DES) deployment. BACKGROUND: IVUS assessment of DES often reveals underexpansion and malapposition. Optimal stent deployment is currently poorly defined and previous criteria may not be suitable in long and complex lesions. METHODS: Optimization was defined as achieving >/or 70% of the cross-sectional area (CSA) of the postdilation balloon. This criterion was applied in 113 complex lesions. The size of this balloon was calculated according to vessel media-to-media diameters at various sites inside the stented segment. The IVUS guided treated lesions were matched according to diabetes, vessel type, reference vessel diameter, minimum lumen diameter (MLD), and lesion length with a group of angiographic treated lesions to compare final MLD achieved. RESULTS: Mean minimum stent CSA according to the postdilation balloon utilized was 4.62 mm(2), 6.26 mm(2), 7.87 mm(2), and 9.87 mm(2) for 2.5 mm, 3.0 mm, 3.5 mm, and 4 mm balloons, respectively. Final MLD (mm) was significantly larger in the IVUS compared to the angiographic-guided group (3.09 +/- 0.50 vs. 2.67 +/- 0.54; P < 0.0001). There were no procedural complications related to IVUS use. CONCLUSIONS: We propose new IVUS criteria based on vessel remodeling that results in an increment in the final MLD, compared to angiographic guidance, which is much larger than any previously published study. This criterion seems to be safely achievable. A proposed randomized study (angiographic vs. IVUS optimization trial) has been launched to test these concepts.
Abstract: BACKGROUND: Patients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high-risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in MI patients has not been extensively studied. METHODS: In this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST-elevation MI [STEMI] and 39 non-ST-elevation MI [NSTEMI]) from 2002 to 2006. RESULTS: The mean age was 70 +/- 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 +/- 8. Angiographic success was achieved in all patients. Overall in-hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 +/- 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07-17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90-0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62-30.21), P = 0.009) were significantly associated with increased mortality. CONCLUSIONS: Patients with MI and ULMCA disease represent a very high-risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long-term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients.
Abstract: BACKGROUND: Sirolimus-eluting stents have been reported to be effective in the treatment of coronary bifurcations. Still, it has not been fully clarified which strategy would provide the best results with true bifurcation lesions. METHODS AND RESULTS: The CACTUS trial (Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents) is a prospective, randomized, multicenter study comparing 2 different techniques of stenting, with mandatory final kissing-balloon inflation, in true bifurcations: (1) elective "crush" stenting and (2) stenting of only the main branch, with provisional side-branch T-stenting. From August 2004 to June 2007, 350 patients were enrolled in 12 European centers. The primary angiographic end point was the in-segment restenosis rate, and the primary clinical end point was the occurrence of major adverse cardiac events (cardiac death, myocardial infarction, or target-vessel revascularization) at 6 months. At 6 months, angiographic restenosis rates were not different between the crush group (4.6% and 13.2% in the main branch and side branch, respectively) and the provisional stenting group (6.7% and 14.7% in the main branch and side branch, respectively; P=NS). Additional stenting on the side branch in the provisional stenting group was required in 31% of lesions. Rates of major adverse cardiac events were also similar in the 2 groups (15.8% in the crush group versus 15% in the provisional stenting group, P=NS). CONCLUSIONS: In most bifurcations with a significant stenosis in both branches, a provisional strategy of stenting the main branch only is effective, with the need to implant a second stent on the side branch occurring in approximately one third of cases. The implantation of 2 stents does not appear to be associated with a higher incidence of adverse events at 6 months.
Abstract: Percutaneous coronary intervention (PCI) is not associated with reduction in risk of death or myocardial infarction in patients who have chronic stable angina with normal left ventricular function and moderate coronary artery disease. A substudy of the COURAGE trial has shown that both PCI plus optimal medical therapy (OMT) and OMT alone result in marked improvements in quality of life and angina, but that PCI can substantially benefit patients with more-severe and more-frequent angina. A number of caveats to this study exist, including the extent to which the findings can be applied to the general patient population and the large proportion of patients who had mild angina or were asymptomatic--it is difficult to make these patients feel better. In addition, the remarkable commitment of both healthcare providers and patients in this study would be hard to achieve in clinical practice. Nevertheless, for patients with mild or no angina and no significant ischemia on stress testing, the COURAGE trial reassures us that OMT alone can be efficacious in reducing angina and/or improving quality of life.
Abstract: A 43-year-old woman presented with exertional dyspnea. On investigation, she was found to have ischemic left ventricular dysfunction on the basis of an anomalous left coronary artery originating from the pulmonary artery. She underwent successful surgical correction of this congenital anomaly that usually presents in childhood.
Abstract: Based on the results of numerous randomised trials, the provisional approach of implanting one stent on the main branch has become the default approach to most bifurcation lesions. However, bifurcation intervention still remains technically challenging. Dedicated bifurcation stents have been designed to specifically treat coronary bifurcations with the aim of dealing with some of the shortcomings of the conventional percutaneous approach to bifurcation intervention. Most of the devices are aimed at facilitating the provisional approach. They are an exciting and innovative technology that may further simplify the management and current approach to bifurcation treatment. Currently, 11 devices are available that have either completed or are currently undergoing First-In-Man trials. The development of more drug-eluting platforms and larger studies with control groups demonstrating their clinical applicability, efficacy and safety are required before they are widely incorporated into daily practice.
Abstract: BACKGROUND: The aim of the study was to compare the outcomes of sirolimus-eluting (SES) and paclitaxel-eluting (PES) stent implantation in coronary bifurcations treated with either a 1-stent or 2-stent strategy. METHODS: The study used a retrospective cohort analysis of consecutive de novo bifurcations, excluding left main, treated with SES or PES between April 2003 and June 2005. RESULTS: We identified 170 bifurcations in 161 patients treated with SES and 119 bifurcations in 112 patients treated with PES. During a median follow-up of 1,061 days (interquartile range 814-1,314), 43 patients (26.7%) in the SES group and 28 (25.0%) in the PES group had a major adverse cardiac event (P = .78). The angiographic restenosis rate per bifurcation was 20.9% and 25.9%, respectively (P = .41). There was no difference overall in the occurrence of target lesion revascularization (TLR) per bifurcation, 22 with SES (12.9%) and 18 with PES (15.1%), P = .61. The TLR rate was similar for SES and PES in bifurcations treated with 1 stent (6.7% vs 11.4%, P = .40) and in bifurcations treated with both branch stenting (20.0% vs 20.4%, P =1.0). CONCLUSIONS: In this cohort, the long-term clinical outcomes appear similar overall between SES and PES in the treatment of coronary bifurcations irrespective of whether a 1-stent or 2-stent strategy was used.
Abstract: Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.
Abstract: With the introduction of drug-eluting stents (DES) the problem of restenosis after percutaneous stent implantation was partially resolved. In the first generation of DES a stainless steel platform was coated with a durable polymer eluting and controlling the release of an active restenotic drug. The impairment of re-endothelization after DES implantation, one of the causes of late stent thrombosis, was to some extent attributed to the properties of the durable polymer and/or drug that it eluted. The introduction of biodegradable platforms and biocompatible polymers may potentially address this issue. Modern technologies are being applied to improve the characteristics of biodegradable stents and find new active pharmacological agents or combinations of standard antirestenotic and antithrombotic drugs that can be eluted from the stents, in order to improve their safety profile and clinical utility.
Abstract: The treatment of hemorrhagic complications of percutaneous interventions with protamine is an accepted practice. Concerns exist about the increased thrombo-genicity of drug-eluting stents. We report two cases of acute stent thrombosis following drug-eluting stent implantation related to protamine administration.
Abstract: Objectives: To assess the utilization of microinjection of contrast for the recanalization of chronic total occlusions (CTO). Background: Microchannels in CTOs have been considered important conduits for CTO crossing, utilizing dedicated guidewires. We postulated that microinjection of contrast immediately distal to the proximal cap of the CTO could identify and enlarge these microvessels, creating a passage for crossing the CTO with a floppy guidewire. Methods: A total of 32 patients with a CTO were treated with this technique. Following few millimetres penetration of the proximal fibrous cap of the occlusion with a dedicated CTO guidewire, the over-the-wire balloon was advanced into the proximal portion of the occlusion, and 50-100 mug of nitroglycerine followed by 1 ml of contrast was gently injected into the occluded segment. Technical success of the microchannel technique was defined as the ability to visualize the distal true lumen with microinjection of contrast and thereafter cross the CTO with a floppy guidewire in the absence of any dissection. Results: Overall, technical success of the microchannel technique was obtained in 20 (63%) with angiographic success in 19. In 12 (37%) cases there was a technical failure because of dissection, and we obtained recanalization of the artery in 7 of these 12 cases with another technique. There was only one case of periprocedural myocardial infarction in an unsuccessful procedure and no major adverse cardiac events or subacute stent thromboses were observed. Conclusions: Microinjection of contrast immediately distal to the proximal fibrous cap of a CTO may be an additional technique to facilitate recanalization of CTO. (c) 2008 Wiley-Liss, Inc.
Abstract: In this case report, we describe the use of coronary techniques and devices in the treatment of a complex popliteal artery bifurcation. In particular, we demonstrate that the Venture wire control catheter is a useful tool not only in coronary lesions but also in wiring angulated peripheral lesions.
Abstract: Aims To evaluate the occurrence of late and very late stent thrombosis (ST) following elective drug-eluting stent (DES) implantation in unprotected left main coronary artery (LMCA) stenosis in a large multicentre registry. Methods and results All 731 consecutive patients who had sirolimus- or paclitaxel-eluting stent electively implanted in de novo lesions on unprotected LMCA in five centres were included. ST was defined according to Academic Research Consortium definitions. Four (0.5%) patients had a definite ST: three early (two acute and one subacute) and one late ST, no cases of very late definite ST were recorded. All patients survived from the event. Three patients had a probable ST. Therefore, 7/731 (0.95%) patients had a definite or a probable ST and all were on dual antiplatelet therapy at the time of the event. Possible (eight late and 12 very late) ST occurred in 20 (2.7%) patients. At 29.5 +/- 13.7 months follow-up, a total of 45 (6.2%) patients had died; 31 (4.2%) of cardiac death. Ninety five (12.9%) patients had a target-vessel and 76 (10.4%) a target-lesion revascularization. Angiographic follow-up was performed in 548 patients (75%): restenosis occurred in 77 (14.1%) patients. Conclusion Elective treatment of LMCA stenosis with DES appears safe with a 0.9% incidence of definite and probable ST at 29.5 +/- 13.7 months.
Abstract: OBJECTIVES: To assess the procedural and clinical outcomes from a modified subintimal tracking and re-entry (STAR) procedure performed using contrast guidance. BACKGROUND: Previous data showed that recanalizing a chronic total occlusion (CTO) with the STAR technique was possible. However, this technique was considered difficult and therefore has only been adopted by a limited number of experienced operators. METHODS: Patients (n = 68) with a CTO of a native coronary artery treated by a single operator with this technique were included. RESULTS: The right coronary artery was involved in 79.4%, the morphology was blunt in 77.9%, and CTO length was longer than 20 mm in 67.6%. Angiographic success rate was 80.9% with a 70.6% rate of complete recanalization. Stent implantation was performed in 82.3% of cases, with drug-eluting stents (DES) implanted in the majority (92.7%). Procedural complications occurred in 10.3% of cases. There were no episodes of myocardial infarction during follow-up, with 1 case (1.5%) of cardiac death. There were no cases of definite or probable stent thrombosis, and there was 1 (1.5%) possible stent thrombosis. The overall rate of in-segment binary restenosis was 44.7%, and target lesion revascularization (TLR) was performed in 25% of lesions. The rate of TLR in lesions treated with DES was 29.4% and in those treated with bare-metal stents was 50%. CONCLUSION: The contrast-guided STAR technique appears to be feasible and relatively safe. However, this procedure is limited by a high rate of restenosis even with DES, and a second procedure may be necessary to obtain a definitive result.
Abstract: The percutaneous treatment of coronary bifurcations has moved past an important milestone in that the 1- versus 2-stent debate appears to have been resolved. The provisional approach of implanting one stent on the main branch should be the default approach in most bifurcations lesions. Selection of the most appropriate strategy for an individual bifurcation is important. Some bifurcations require 1 stent, whereas others require the stenting of both branches. Irrespective of whether a 1- or 2-stent strategy is chosen, the results after bifurcation percutaneous coronary intervention (PCI) have dramatically improved. Dedicated bifurcation stents are an exciting new technology that may further simplify the management of bifurcation PCI and change some of these concepts.
Abstract: OBJECTIVES: The purpose of this study was to evaluate the safety of dual antiplatelet therapy in patients in whom long-term anticoagulation (AC) with warfarin is recommended. BACKGROUND: The optimal antithrombotic strategy after percutaneous coronary intervention (PCI) for patients receiving AC is unclear. METHODS: Consecutive patients who underwent stent implantation and were discharged on triple therapy (defined as the combination of aspirin and thienopyridines and AC) were analyzed. RESULTS: Of the 127 patients with 224 lesions, 86.6% were men, with a mean age of 69.9 +/- 8.8 years. Drug-eluting stents (DES) were positioned in 71 (55.9%), and bare-metal stents (BMS) were positioned in 56 (44.1%) patients. Atrial fibrillation (AF) was the main indication (59.1%) for AC treatment. The mean triple therapy duration was 5.6 +/- 4.6 months, and clinical follow-up was 21.0 +/- 19.8 months. During the triple therapy period, 6 patients (4.7%) developed major bleeding complications; 67% occurred within the first month. No significant differences between DES and BMS were observed in the incidence of major (5.6% vs. 3.6%, respectively, p = 1.0) and minor (1.4% vs. 3.6%, respectively, p = 0.57) bleeding and mortality (5.6% vs. 1.8%, respectively, p = 0.39). A significant difference was observed in favor of DES in target vessel revascularization (14.1% vs. 26.8%, p = 0.041). CONCLUSIONS: While receiving triple therapy, major bleeding occurred in 4.7% of patients; one-half of the events were lethal, and most occurred within the first month.
Abstract: Prolonged periods of dual antiplatelet therapy (DAT), i.e., aspirin plus a thienopyridine, are currently recommended to prevent late drug-eluting stent (DES) thrombosis. The aim of our study was to determine the risk and predictors of bleeding and compliance associated with such prolongation of DAT. In this observational study we examined 2,355 consecutive patients undergoing successful DES implantation at 4 hospitals in Italy from June 2002 to December 2004. Bleeding events occurring on DAT and warfarin or in the first 30 days after stent implantation were excluded. Median duration of DAT was 209 days (interquartile range 178 to 444) and only 158 patients (6.7%) prematurely discontinued DAT. The overall bleeding rate was 1.9% (45), with major bleeding in 19 (0.8%) and minor bleeding in 26 (1.1%). Independent predictors of bleeding were DAT (hazard ratio 19.8, 95% confidence interval [CI] 3.69 to 106.34, p <0.001) and age >65 years (hazard ratio 2.15, 95% CI 1.16 to 4.00, p = 0.02). In patients on DAT, the incidence rate (30 days to 18 months) of any bleeding event was 2.57 per 100 person-years (95% CI 1.85 to 3.48) and major bleeding was 1.10 per 100 person-years (95% CI 0.65 to 1.74). In conclusion, DAT after DES implantation is well tolerated and associated with a very low risk of major bleeding.
Abstract: This study reports long-term follow-up of the on- and off-label implantation of drug-eluting stents (DESs) in a retrospective study of 1,044 patients. Off-label implantation of DESs was performed for left main coronary artery lesions, bifurcation lesions, bare metal stent restenosis, ostial disease, chronic total occlusions, saphenous vein graft lesions, internal mammary artery graft lesions, left ventricular ejection fraction <30%, and acute myocardial infarction. End points examined were procedural complications, in-hospital myocardial infarction, and acute stent thrombosis; end points examined at follow-up were subacute stent thrombosis, late stent thrombosis, target vessel revascularization, myocardial infarction, death, and major adverse clinical events (MACEs; a composite of death, myocardial infarction, and target vessel revascularization). The study included 364 patients who received a DES on an on-label basis and 680 patients who received a DES on an off-label basis. Patient characteristics were not significantly different between the 2 groups, and there was no difference in procedural complications or acute stent thrombosis (on-label, 0%; off-label, 0.3%; p=0.55). There were no significant differences in subacute stent thrombosis (0% vs 0.6%, p=0.3), late stent thrombosis (1.4% vs 1.2%, p=0.78), death at follow-up (4.9% vs 4.1%, p=0.53), or myocardial infarction (1.9% vs 2.4%, p=0.83). Off-label DES implantation was associated with higher rates of target vessel revascularization (13.2% vs 24.1%, p=0.0001) and MACEs (17.6% vs 28.2%, p=0.0001). Multivariate analysis showed associations between target vessel revascularization and MACEs (respective p values) with bare metal stent restenosis (p=0.001 and p=0.001), diabetes mellitus (p=0.002 and p=0.001), and previous coronary artery bypass grafting (p=0.04 and p=0.01), but not off-label DES implantation (p=1.36 and p=1.16). In conclusion, DES use in the off-label situations studied was safe and was not associated with increased stent thrombosis, myocardial infarction, or death. Multivariate analysis showed that off-label DES implantation was not a risk factor for target vessel revascularization or MACEs.
Abstract: Recanalization of chronic total occlusions (CTO) remains one of the most technically challenging areas in interventional cardiology. We report a case of retrograde recanalization of a chronically occluded mid-right coronary artery into a right internal mammary graft via a septal collateral. This retrograde approach provides another option for CTO recanalization when the anterograde approach has failed.
Abstract: BACKGROUND: The need for prolonged aspirin and thienopyridine therapy and the risk of stent thrombosis (ST) remain as drawbacks associated with drug-eluting stents. METHODS AND RESULTS: A prospective observational cohort study was conducted between June 2002 and January 2004 on 3021 patients consecutively and successfully treated in 5389 lesions with drug-eluting stents. Detailed patient information was collected on antiplatelet therapy. We analyzed the incidence of ST throughout the 18-month follow-up period and its relationship with thienopyridine therapy. ST occurred in 58 patients (1.9%) at 18 months. Forty-two patients (1.4%) experienced the event within 6 months of stent implantation. Acute myocardial infarction (fatal or nonfatal) occurred in 46 patients (79%) and death in 23 patients (39%) with ST. The median interval from discontinuation of thienopyridine therapy to ST was 13.5 days (interquartile range 5.2 to 25.7 days) for the first 6 months and 90 days (interquartile range 30 to 365 days) between 6 and 18 months. On multivariable analysis, the strongest predictor for ST within 6 months of stenting was discontinuation of thienopyridine therapy (hazard ratio, 13.74; 95% CI, 4.04 to 46.68; P<0.001). Thienopyridine discontinuation after 6 months did not predict the occurrence of ST (hazard ratio, 0.94; 95% CI, 0.30 to 2.98; P=0.92). CONCLUSIONS: Discontinuation of thienopyridine therapy was the major determinant of ST within the first 6 months, but insufficient information is available to determine whether there is benefit in continuing a thienopyridine beyond 6 months.
Abstract: BACKGROUND: The need for prolonged aspirin and thienopyridine therapy and the risk of stent thrombosis (ST) remain as drawbacks associated with drug-eluting stents. METHODS AND RESULTS: A prospective observational cohort study was conducted between June 2002 and January 2004 on 3021 patients consecutively and successfully treated in 5389 lesions with drug-eluting stents. Detailed patient information was collected on antiplatelet therapy. We analyzed the incidence of ST throughout the 18-month follow-up period and its relationship with thienopyridine therapy. ST occurred in 58 patients (1.9%) at 18 months. Forty-two patients (1.4%) experienced the event within 6 months of stent implantation. Acute myocardial infarction (fatal or nonfatal) occurred in 46 patients (79%) and death in 23 patients (39%) with ST. The median interval from discontinuation of thienopyridine therapy to ST was 13.5 days (interquartile range 5.2 to 25.7 days) for the first 6 months and 90 days (interquartile range 30 to 365 days) between 6 and 18 months. On multivariable analysis, the strongest predictor for ST within 6 months of stenting was discontinuation of thienopyridine therapy (hazard ratio, 13.74; 95% CI, 4.04 to 46.68; P<0.001). Thienopyridine discontinuation after 6 months did not predict the occurrence of ST (hazard ratio, 0.94; 95% CI, 0.30 to 2.98; P=0.92). CONCLUSIONS: Discontinuation of thienopyridine therapy was the major determinant of ST within the first 6 months, but insufficient information is available to determine whether there is benefit in continuing a thienopyridine beyond 6 months.
Abstract: Microsporidia are intracellular protozoa that are emerging as significant opportunistic infections in AIDS patients. Although there are numerous published reports of intestinal and disseminated infections in patients with AIDS, there have been only two previous reports in transplantation medicine, both on intestinal microsporidiosis. We report here the first documented case of extra-intestinal microsporidiosis in a transplant recipient. A 39-year-old renal transplant recipient presented with a pyrexia and deteriorating graft function. Light microscopic examination of a renal allograft biopsy revealed numerous microsporidian spores within the renal tubular epithelium. Transmission electron microscopy confirmed the presence of an Encephalitozoon infection and was highly suggestive of Encephalitozoon intestinalis. Therapy with albendazole was extremely effective and resulted in recovery of renal function. Although a rare cause of renal allograft dysfunction, microsporidiosis is curable. It may be underdiagnosed, and should be considered in the differential diagnosis of transplant recipients presenting with opportunistic infections.
