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目的评估超过药物洗脱支架(DES)植入后延长双联抗血小板治疗对患者的影响。方法 2008年1月至2010年12月,根据DES植入后12个月的TIMI标准,246例一直接受双联抗血小板(DAPT)并无心肌梗死、卒中、再次冠状血管狭窄、支架内血栓形成、重大或轻微出血的患者被随机分为连续(延长DAPT组)或不连续(标准DAPT组)氯吡格雷组(75 mg/d)。主要终点事件是术后180 d时主要心血管不良事件,包括死亡、非致命心肌梗死、非致命卒中、靶血管重建或支架内血栓形成。结果延长DAPT组和标准DAPT组间在180 d的主要不良心血管事件发病率比较差异无统计学意义(分别为8.98%和10.13%,P=0.400)。较重大出血的发生率在延长DAPT组中为0.64%,而在标准DAPT组中为0.43%(P=0.523);轻微出血的发生率在延长DAPT组与标准DAPT组中分别为3.32%和2.87%(P=0.585)。结论超过12个月的延长DAPT并未改善患者预后,但是也未增加植入DES患者的出血风险。
Objectives To evaluate the effect of prolonging dual antiplatelet therapy on patients beyond implantation of drug-eluting stents (DES). Methods From January 2008 to December 2010, according to the TIMI criteria at 12 months after DES implantation, 246 patients had been treated with dual antiplatelet (DAPT) without myocardial infarction, stroke, coronary stenosis again, stent thrombosis Patients with major or minor bleeding were randomized to clopidogrel (75 mg / d) in continuous (extended DAPT) or discontinuous (standard DAPT) groups. The primary end point was the major cardiovascular adverse event 180 days after surgery, including death, non-fatal myocardial infarction, non-fatal stroke, target revascularization or stent thrombosis. Results There was no significant difference in the incidence of major adverse cardiovascular events between the DAPT group and the standard DAPT group at 180 days (8.98% vs 10.13%, P = 0.400, respectively). The incidence of major bleeding was 0.64% in the extended DAPT group and 0.43% in the standard DAPT group (P = 0.523). The incidence of minor bleeding was 3.32% and 2.87 in the extended DAPT group and the standard DAPT group % (P = 0.585). Conclusions Extended DAPT beyond 12 months did not improve patient outcomes, but did not increase the risk of bleeding in patients undergoing DES implantation.