Context: Compared with bare metal stents, sirolimus-elut-ing and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but thei...Context: Compared with bare metal stents, sirolimus-elut-ing and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective: To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design: Prospective, randomized comparative trial(the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting: Ninety hospitals in Europe, Latin America, and Asia. Patients: A total of 1386 patients(mean age, 62.6 years; 73.1% men; 28.0% with diabetes)with angina pectoris and 1 or 2 de novo lesions(2.25-3.00 mm in diameter) in native coronary arteries. Intervention: Patients were randomly assigned in a 1 ∶ 1 ratio to receive a sirolimus-eluting stent(n=701) or a paclitaxel-eluting stent(n=685). Main Outcome Measures: The primary end point was in-lesion binary restenosis(presence of a more than 50% luminal diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results: In-lesion binary restenosis at 8 months occurred in 86 patients(9.6% ) with a sirolimus-eluting stent vs 95(11.1% ) with a paclitaxel-eluting stent(relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P=.31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean(SD) in-stent late loss was 0.09(0.43) mm vs 0.31(0.44) mm(difference,-0.22 mm; 95% CI,-0.26 to-0.18 mm; P<.001), mean(SD) in-stent diameter stenosis was 23.1% (16.6% ) vs 26.7% (15.8% )(difference,-3.60% ; 95% CI,-5.12% to-2.08% ; P< .001), and the number of major adverse cardiac events at 1 year was 73(10.7%展开更多
美国心脏病学会(ACC)、美国心脏协会(AHA)、心血管造影和介入学会(society for cardiovascular angiography and interventions,SCAI)2021年12月联合发布了新版冠状动脉(简称冠脉)血运重建指南。新指南结合近年来冠脉血运重建的循证医...美国心脏病学会(ACC)、美国心脏协会(AHA)、心血管造影和介入学会(society for cardiovascular angiography and interventions,SCAI)2021年12月联合发布了新版冠状动脉(简称冠脉)血运重建指南。新指南结合近年来冠脉血运重建的循证医学证据和临床诊疗实践,对稳定性缺血性心脏病、非ST段抬高型急性冠脉综合征和ST段抬高型心肌梗死的血运重建策略进行更新,涵盖了冠脉疾病的药物、介入以及外科治疗等综合管理策略,从病变评估到方案选择、从治疗到康复等方面进行了阐述。本文就新指南亮点进行了解读,旨在为临床实践提供参考。展开更多
文摘Context: Compared with bare metal stents, sirolimus-elut-ing and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective: To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design: Prospective, randomized comparative trial(the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting: Ninety hospitals in Europe, Latin America, and Asia. Patients: A total of 1386 patients(mean age, 62.6 years; 73.1% men; 28.0% with diabetes)with angina pectoris and 1 or 2 de novo lesions(2.25-3.00 mm in diameter) in native coronary arteries. Intervention: Patients were randomly assigned in a 1 ∶ 1 ratio to receive a sirolimus-eluting stent(n=701) or a paclitaxel-eluting stent(n=685). Main Outcome Measures: The primary end point was in-lesion binary restenosis(presence of a more than 50% luminal diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results: In-lesion binary restenosis at 8 months occurred in 86 patients(9.6% ) with a sirolimus-eluting stent vs 95(11.1% ) with a paclitaxel-eluting stent(relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P=.31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean(SD) in-stent late loss was 0.09(0.43) mm vs 0.31(0.44) mm(difference,-0.22 mm; 95% CI,-0.26 to-0.18 mm; P<.001), mean(SD) in-stent diameter stenosis was 23.1% (16.6% ) vs 26.7% (15.8% )(difference,-3.60% ; 95% CI,-5.12% to-2.08% ; P< .001), and the number of major adverse cardiac events at 1 year was 73(10.7%
文摘美国心脏病学会(ACC)、美国心脏协会(AHA)、心血管造影和介入学会(society for cardiovascular angiography and interventions,SCAI)2021年12月联合发布了新版冠状动脉(简称冠脉)血运重建指南。新指南结合近年来冠脉血运重建的循证医学证据和临床诊疗实践,对稳定性缺血性心脏病、非ST段抬高型急性冠脉综合征和ST段抬高型心肌梗死的血运重建策略进行更新,涵盖了冠脉疾病的药物、介入以及外科治疗等综合管理策略,从病变评估到方案选择、从治疗到康复等方面进行了阐述。本文就新指南亮点进行了解读,旨在为临床实践提供参考。
