Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents

Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents
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DOI:
10.1016/j.jcin.2015.10.001
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发表时间:
2016-01-25
影响因子:
11.3
通讯作者:
Mauri, Laura
Mauri, Laura
中科院分区:
医学1区
文献类型:
--
作者:
Hermiller, James B.;Krucoff, Mitchell W.;Mauri, Laura

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本研究的目的是描述依维莫司洗脱支架(EES)治疗的受试者在支架植入后12至30个月内持续噻吩并吡啶加阿司匹林与单独阿司匹林治疗的结局。背景在DAPT(双重抗血小板治疗)研究中,冠状动脉支架植入后1年内持续噻吩并吡啶加阿司匹林可减少缺血事件。鉴于目前药物洗脱支架的支架血栓形成和心肌梗死(MI)发生率较低,我们研究了DAPT研究中EES治疗受试者的结局。噻吩并吡啶和阿司匹林治疗12个月后,合格受试者继续接受阿司匹林治疗,9,961例(4,703例接受EES治疗)随机接受18个月的噻吩并吡啶或安慰剂治疗。支架类型不是随机的,EES亚组分析是事后分析。结果在EES治疗的患者中,持续噻吩并吡啶减少了支架内血栓形成(0.3% vs. 0.7%,风险比[HR]:0.38,95%置信区间[CI]:0.15 - 0.97; p = 0.04)和MI(2.1% vs. 3.2%,HR:0.63,95% CI:0.44 - 0.91; p = 0.01),但未降低死亡、MI和卒中的复合终点(4.3% vs. 4.5%,HR:0.89,95% CI:0.67 - 1.18; p = 0.42),中度/重度出血增加(2.5% vs. 1.3%,HR:1.79,95% CI:1.15 - 2.80; p = 0.01)和死亡(2.2% vs. 1.1%,HR:1.80,95% CI:1.11 - 2.92; p = 0.02)。与出血无关的癌症死亡率增加(0.64%对0.17%; p = 0.01)。结论:与单独使用阿司匹林相比,持续使用噻吩并吡啶超过1年后,在EES治疗的受试者中,支架内血栓形成和MI显著减少,出血增加。(The双重抗血小板治疗研究[DAPT研究]); NCT 00977938)(J Am科尔Cardiol Intv 2016; 9:138-47)(C)美国心脏病学会基金会2016年。
OBJECTIVES The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)-treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting.BACKGROUND In the DAPT (Dual Antiplatelet Therapy) study, continued thienopyridine plus aspirin beyond 1 year after coronary stenting reduced ischemic events. Given low rates of stent thrombosis and myocardial infarction (MI) for current drug-eluting stents, we examined outcomes among EES-treated subjects in the DAPT study.METHODS The DAPT study enrolled 25,682 subjects (11,308 EES-treated) after coronary stenting. Following 12 months of treatment with thienopyridine and aspirin, eligible subjects continued treatment with aspirin and 9,961 (4,703 with EES) were randomized to 18 months of continued thienopyridine or placebo. Stent type was not randomized, and the EES subset analysis was post hoc.RESULTS Among EES-treated patients, continued thienopyridine reduced stent thrombosis (0.3% vs. 0.7%, hazard ratio [HR]: 0.38, 95% confidence interval [CI]: 0.15 to 0.97; p = 0.04) and MI (2.1% vs. 3.2%, HR: 0.63, 95% CI: 0.44 to 0.91; p = 0.01) versus placebo but did not reduce a composite of death, MI, and stroke (4.3% vs. 4.5%, HR: 0.89, 95% CI: 0.67 to 1.18; p = 0.42), and increased moderate/severe bleeding (2.5% vs. 1.3%, HR: 1.79, 95% CI: 1.15 to 2.80; p = 0.01), and death (2.2% vs. 1.1%, HR: 1.80, 95% CI: 1.11 to 2.92; p = 0.02). Death due to cancer and not related to bleeding was increased (0.64% vs. 0.17%; p = 0.01).CONCLUSIONS In EES-treated subjects, significant reductions in stent thrombosis and MI and an increase in bleeding were observed with continued thienopyridine beyond 1 year compared with aspirin alone. (The Dual Antiplatelet Therapy Study [DAPT Study]); NCT00977938) (J Am Coll Cardiol Intv 2016; 9: 138-47) (C) 2016 by the American College of Cardiology Foundation.