Abstract: OBJECTIVES: To analyze the effectiveness of the transradial approach in reducing bleeding rates following urgent percutaneous coronary intervention (PCI) in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors (GPIs). BACKGROUND: PCI and use of GPIs are recommended in acute coronary syndromes, but are strong predictors of severe hemorrhagic complications, which, in turn, are associated with reduced survival. The transradial approach represents a simple and effective solution to reduce vascular access site bleedings, particularly with GPIs. METHODS: All consecutive patients undergoing urgent transradial PCI under GPI treatment were enrolled in the registry. No patients were excluded. In addition, we performed a case-matched comparison of the transradial versus transfemoral approach using propensity analysis to adjust for known risk factors for bleeding. The primary end point was the rate of bleedings, graded according to the Thrombolysis in Myocardial Infarction (TIMI) classification. RESULTS: Five hundred thirty-one consecutive patients were prospectively enrolled in the registry. TIMI major, minor, and minimal bleedings were 0.2%, 1.7%, and 6.4%, respectively. Transfusion rate was 0.8%. After propensity-matched analysis, the transradial approach was associated with significantly lower rates of all types of bleedings, while the transfemoral approach was the strongest predictor of TIMI major/minor bleedings (odds ratio 6.67; 95% confidence interval 1.72-25; P = 0.006). CONCLUSIONS: The transradial approach dramatically reduces access site bleedings, including TIMI major and minor bleedings, and transfusion rate, while preserving procedural success and clinical outcome. The transradial approach is an attractive solution to reduce bleeding complications in patients treated with GPIs.
Abstract: AIMS: In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES). METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38). CONCLUSION: Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.
Abstract: A patient with an acute coronary syndrome underwent coronary angiography, which showed only a moderate stenosis in the mid portion of the left anterior descending artery. Intravascular ultrasound was performed for a better assessment of the lesion, and surprisingly, it showed a myocardial bridge over the narrowed segment, which was unapparent at angiography. In fact, the systolic compression of the artery was very limited, and no 'step down-step up' course was recognized. Given the absence of significant atherosclerosis in the intramyocardial and adjacent segments, and considering the poor results reported for stenting of tunnelled coronary arteries, we decided to treat the patient medically. At 6-month follow-up, the patient is asymptomatic and has no inducible ischemia.In conclusion, this case shows how intravascular ultrasound can be useful in patients with an unclear angiographic diagnosis for a better patient management.
Abstract: OBJECTIVES: The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). BACKGROUND: Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. METHODS: We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. RESULTS: At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). CONCLUSIONS: In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.
Abstract: Glycoprotein (GP) IIb/IIIa receptor inhibitors before primary angioplasty in patients with ST-elevation acute myocardial infarction (STEMI) are recommended by current guidelines. Thus, an increasing number of patients receive these drugs before coronary angiography, particularly if a between-hospital transfer is needed. However, when coronary anatomy is unsuitable for angioplasty, emergency coronary artery bypass grafting (CABG) under GP IIb/IIIa inhibitor treatment may be needed, with a potential increase in bleeding risk. Abciximab has a long duration of action, because of its high-affinity binding to GP IIb/IIIa receptors. Initial retrospective studies reported a higher incidence of major bleeding during emergency CABG after abciximab administration, leading to the recommendation of delaying surgery >12 h. However, data from the prospective trials on abciximab do not confirm the increase in bleeding risk, and current evidence shows that emergency surgery can be performed safely soon after abciximab cessation. Monitoring of activated clotting time during surgery and platelet transfusion in case of postoperative relevant bleeding are the only measures needed. No data are available on emergency surgery in patients with STEMI treated with eptifibatide or tirofiban. However, their short-lasting effects and the results of trials on non-ST-elevation acute coronary syndromes suggest that they could even reduce postoperative bleeding by preventing platelet consumption during cardiopulmonary bypass. In conclusion, the early administration of GP IIb/IIIa inhibitors, in particular of abciximab, in patients with STEMI in whom primary angioplasty is planned should not be discouraged because of the potential bleeding risk in case of emergency CABG.
Abstract: BACKGROUND: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously "rinses" the vessel with turbulent flow and aspirates thrombus. METHODS: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was >or=50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous electrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). RESULTS: Mean symptom-to-PCI time was 4.7 +/- 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush >or=2 in 78%. Rates of STR >or= 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. CONCLUSIONS: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit.
Abstract: BACKGROUND: Distal unprotected left main coronary artery (ULMCA) stenosis represents a technical challenge for interventional cardiologists. In this study, we compared 2-year clinical outcomes of different stenting strategies in patients with distal ULMCA stenosis treated with drug-eluting stents. METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study on patients with ULMCA stenosis treated with percutaneous coronary intervention. In this study, we selected patients with distal ULMCA stenosis treated with drug-eluting stents. Seven hundred seventy-three patients were eligible for this study: 456 were treated with 1 stent (group 1) and 317 with 2 stents (group 2). The primary end point of the study was the incidence of major adverse cardiac events (MACEs), defined as the occurrence of mortality, myocardial infarction, and target lesion revascularization. During a 2-year follow-up, risk-adjusted survival free from MACE was significantly higher in patients in group 1 than in patients in group 2. The propensity-adjusted hazard ratio for the risk of 2-year MACE in patients in group 1 versus group 2 was 0.53 (95% CI, 0.37 to 0.76). The propensity-adjusted hazard ratio for the risk of 2-year cardiac mortality and myocardial infarction in patients in group 1 versus group 2 was 0.38 (95% CI, 0.17 to 0.85). CONCLUSIONS: Compared with the 2-stent technique, the 1-stent technique is associated with a better 2-year MACE-free survival. The stenting strategy is a prognostic factor that should be taken into account when deciding the optimal revascularization treatment.
Abstract: OBJECTIVE: To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. DESIGN: Collaborative network meta-analysis. DATA SOURCES: Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. REVIEW METHODS: Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. RESULTS: 35 trials in 3852 people with diabetes and 10,947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. CONCLUSION: In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes.
Abstract: Data are limited about the relative efficacy of drug-eluting stents (DESs) versus bare-metal stents (BMSs) for the treatment of unprotected left main coronary artery (ULMCA) stenosis. The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centers of patients with ULMCA stenosis treated using percutaneous coronary intervention (PCI). From January 2002 to December 2006, of 1,453 patients identified with ULMCA stenosis treated with PCI, 1,111 were treated with DESs and 342 were treated with BMSs. During a 2-year follow-up, risk-adjusted survival free from cardiac death was significantly higher in patients treated with DESs than in those treated with BMSs. The propensity-adjusted hazard ratio for risk of 2-year cardiac mortality after DES versus BMS implantation was 0.49 (95% confidence interval 0.32 to 0.77). The benefit of DESs in reducing cardiac mortality was obtained in the period from 3 to 6 months and maintained up to 2 years. In conclusion, for patients with ULMCA stenosis undergoing PCI, DES implantation was associated with higher adjusted rates of 2-year survival free from cardiac death. The benefit of DESs in reducing cardiac mortality was obtained in the period in which clinical manifestations of restenosis usually peak.
Abstract: OBJECTIVES: The goal of this work was to verify whether the superiority of the sirolimus-eluting stent (SES) in inhibiting neointimal hyperplasia could be demonstrated in complex coronary lesions. BACKGROUND: Both the SES (Cypher, Cordis, Miami Lakes, Florida) and the paclitaxel-eluting stent (PES) (Taxus, Boston Scientific, Natick, Massachusetts) have shown a marked reduction in neointimal hyperplasia compared with bare-metal stents. Intravascular ultrasound (IVUS) is the best method to assess arterial response to stent deployment, but few IVUS data are available comparing complex lesions treated with SES or PES. METHODS: We prospectively randomized patients with complex lesions to SES or PES implantation. Intravascular ultrasound and quantitative angiography were performed post-procedure and at 9 months. Mean neointimal hyperplasia area (NIHA), percent of NIHA (NIHA%), mean peristent plaque area (PSPA), and percent of PSPA (PSPA%) were calculated. The primary end point was NIHA% at follow-up. Secondary end points included change in PSPA% and angiographic late luminal loss at follow-up. RESULTS: Of the 100 patients enrolled, 42 receiving the SES and 43 receiving the PES had adequate IVUS assessment. Vessel, plaque, and lumen areas were comparable at follow-up, but NIHA% was significantly lower with SES than PES (7.4 +/- 4.2% vs. 15.4 +/- 8.1%; p < 0.001). A significant reduction in PSPA% was observed with SES (-4 +/- 10% vs. 0 +/- 8%; p = 0.01). Late loss was significantly lower with SES (0.16 +/- 0.19 mm vs. 0.32 +/- 0.33 mm; p = 0.003). CONCLUSIONS: The SES shows a significantly higher inhibition of neointimal hyperplasia compared with PES in complex lesions. However, both stents have excellent IVUS and angiographic results at 9 months. A significant reduction in peri-stent plaque is observed only with SES.
Abstract: BACKGROUND: Primary angioplasty is the best treatment of acute myocardial infarction but fails to achieve adequate myocardial reperfusion in 25% to 30% of patients, despite TIMI grade 3 flow. Drug treatment aimed at reducing the no-reflow phenomenon may improve myocardial salvage, thus preventing left ventricular remodeling. Our aim was to evaluate the impact of abciximab and adenosine on immediate angiographic results and on 6-month left ventricular remodeling. METHODS: Ninety consecutive patients undergoing primary angioplasty with coronary stenting were randomized in a sequential alternating fashion to standard abciximab treatment (ABCX) group, intracoronary adenosine distal to the occlusion (ADO) group, or neither (CTRL) group. All patients underwent a clinical and echocardiographic follow-up at 1 and 6 months. The primary end point was the prevalence of 6-month left ventricular remodeling. RESULTS: Baseline clinical, echocardiographic, and angiographic characteristics were similar. Mean final corrected TIMI frame count was 17 +/- 9, 16 +/- 12, and 23 +/- 11 frames in ABCX, ADO, and CTRL patients, respectively (P = .002). Angiographic no-reflow was observed in 7%, 13%, and 17% of ABCX, ADO, and CTRL patients, respectively (P > .20). At 6 months, left ventricular remodeling occurred in 7%, 30%, and 30% of ABCX, ADO, and CTRL patients, respectively (P = .045), with a percent increase in end-diastolic volume of 5% +/- 13%, 15% +/- 15%, and 12% +/- 18% (P = .04). CONCLUSIONS: During primary angioplasty, abciximab enhances myocardial reperfusion, translating into a reduced incidence of 6-month left ventricular remodeling. In contrast, adenosine administration improves angiographic results but does not prevent left ventricular remodeling.
