From the Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (T.K.P., Y.B.S., J.-Y.H., J.H.Y., S.-H.C., J.-H.C., S.H.L., H.-C.G.); Department of Biostatistics and Clinical Epidemiology, Samsung Medical Center, Seoul, Republic of Korea (J.A., K.C.C.); and Department of Mathematical and Statistical Sciences, University of Alberta, Edmonton, Alberta, Canada (K.C.C.).
Circ Cardiovasc Interv. 2016 Jan;9(1):e002816. doi: 10.1161/CIRCINTERVENTIONS.115.002816.
The use of dual-antiplatelet therapy (DAPT) exceeding 12 months may increase a bleeding risk despite a lower risk of ischemic events. There is no study to compare clinical outcomes in patients treated with a single-antiplatelet drug after DAPT in the era of drug-eluting stents (DES). We sought to investigate the efficacy and safety of clopidogrel versus aspirin monotherapy after 12-month DAPT after DES implantation using an institutional registry.
This observational study was conducted on consecutive patients receiving DES between January 2003 and December 2010. A total of 3243 patients receiving 12-month DAPT after DES implantation without adverse clinical outcomes were divided into 2 groups based on prescribed antiplatelet status: aspirin (n=2472) and clopidogrel (n=771). Clinical, angiographic, and procedural characteristics revealed more comorbidities and more complex lesions in the clopidogrel group than in the aspirin group. At 36 months after initiation of antiplatelet monotherapy, clopidogrel was associated with a reduction in risk for a composite of cardiac death, myocardial infarction, or stroke (aspirin versus clopidogrel; 3.8% versus 2.6%; hazard ratio, 0.54; 95% confidence interval, 0.32-0.92; P=0.02). The risk of cardiac death was lower with clopidogrel monotherapy than with aspirin monotherapy (1.4% versus 0.5%; hazard ratio, 0.31; 95% confidence interval, 0.11-0.93; P=0.04). Thrombolysis in myocardial infarction major bleeding occurred similarly between both groups (0.9% versus 1.3%; hazard ratio, 1.03; 95% confidence interval, 0.46-2.32; P=0.95).
After 12-month DAPT, clopidogrel monotherapy, when compared with aspirin monotherapy, might be associated with a reduced risk of recurrent ischemic events in patients receiving DES.
尽管缺血事件风险降低,但双联抗血小板治疗(DAPT)超过 12 个月可能会增加出血风险。在药物洗脱支架(DES)时代,尚无研究比较 DAPT 后使用单一抗血小板药物治疗的患者的临床结局。我们旨在通过机构注册研究,调查 DES 植入后 12 个月 DAPT 后氯吡格雷与阿司匹林单药治疗的疗效和安全性。
这项观察性研究纳入了 2003 年 1 月至 2010 年 12 月期间接受 DES 的连续患者。总共纳入 3243 例 DES 植入后接受 12 个月 DAPT 且无不良临床结局的患者,根据处方抗血小板状态将其分为 2 组:阿司匹林组(n=2472)和氯吡格雷组(n=771)。临床、血管造影和手术特征显示氯吡格雷组比阿司匹林组合并症更多且病变更复杂。抗血小板单药治疗开始后 36 个月时,氯吡格雷与心脏死亡、心肌梗死或卒中的复合终点风险降低相关(阿司匹林与氯吡格雷;3.8%比 2.6%;风险比,0.54;95%置信区间,0.32-0.92;P=0.02)。氯吡格雷单药治疗的心脏死亡风险低于阿司匹林单药治疗(1.4%比 0.5%;风险比,0.31;95%置信区间,0.11-0.93;P=0.04)。两组之间心肌梗死溶栓治疗大出血的发生率相似(0.9%比 1.3%;风险比,1.03;95%置信区间,0.46-2.32;P=0.95)。
在接受 DES 的患者中,与阿司匹林单药治疗相比,DAPT 后 12 个月氯吡格雷单药治疗可能与降低复发性缺血事件风险相关。