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药物洗脱支架植入术后,无论患者有无急性冠脉综合征,给予3个月、6个月或12个月双联抗血小板治疗:六项随机试验和11473例患者的个体患者数据成对和网状荟萃分析

Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients.

作者信息

Palmerini Tullio, Della Riva Diego, Benedetto Umberto, Bacchi Reggiani Letizia, Feres Fausto, Abizaid Alexandre, Gilard Martine, Morice Marie-Claude, Valgimigli Marco, Hong Myeong-Ki, Kim Byeong-Keuk, Jang Yangsoo, Kim Hyo-Soo, Park Kyung Woo, Colombo Antonio, Chieffo Alaide, Sangiorgi Diego, Biondi-Zoccai Giuseppe, Généreux Philippe, Angelini Gianni D, Pufulete Maria, White Jonathon, Bhatt Deepak L, Stone Gregg W

机构信息

Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Italy.

Bristol Heart Institute, University of Bristol School of Clinical Sciences, Bristol, Bristol, UK.

出版信息

Eur Heart J. 2017 Apr 7;38(14):1034-1043. doi: 10.1093/eurheartj/ehw627.

Abstract

AIM

We sought to determine whether the optimal dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) placement varies according to clinical presentation.

METHODS AND RESULTS

We performed an individual patient data pairwise and network meta-analysis comparing short-term (≤6-months) versus long-term (1-year) DAPT as well as 3-month vs. 6-month vs 1-year DAPT. The primary study outcome was the 1-year composite risk of myocardial infarction (MI) or definite/probable stent thrombosis (ST). Six trials were included in which DAPT after DES consisted of aspirin and clopidogrel. Among 11 473 randomized patients 6714 (58.5%) had stable CAD and 4758 (41.5%) presented with acute coronary syndrome (ACS), the majority of whom (67.0%) had unstable angina. In ACS patients, ≤6-month DAPT was associated with non-significantly higher 1-year rates of MI or ST compared with 1-year DAPT (Hazard Ratio (HR) 1.48, 95% Confidence interval (CI) 0.98-2.22; P = 0.059), whereas in stable patients rates of MI and ST were similar between the two DAPT strategies (HR 0.93, 95%CI 0.65-1.35; P = 0.71; Pinteraction = 0.09). By network meta-analysis, 3-month DAPT, but not 6-month DAPT, was associated with higher rates of MI or ST in ACS, whereas no significant differences were apparent in stable patients. Short DAPT was associated with lower rates of major bleeding compared with 1-year DAPT, irrespective of clinical presentation. All-cause mortality was not significantly different with short vs. long DAPT in both patients with stable CAD and ACS.

CONCLUSIONS

Optimal DAPT duration after DES differs according to clinical presentation. In the present meta-analysis, despite the fact that most enrolled ACS patients were relatively low risk, 3-month DAPT was associated with increased ischaemic risk, whereas 3-month DAPT appeared safe in stable CAD. Prolonged DAPT increases bleeding regardless of clinical presentation. Further study is required to identify the optimal duration of DAPT after DES in individual patients based on their relative ischaemic and bleeding risks.

摘要

目的

我们试图确定药物洗脱支架(DES)置入术后的最佳双联抗血小板治疗(DAPT)持续时间是否因临床表现而异。

方法与结果

我们进行了一项个体患者数据的成对和网络荟萃分析,比较短期(≤6个月)与长期(1年)DAPT以及3个月、6个月与1年DAPT。主要研究结局是心肌梗死(MI)或明确/可能的支架血栓形成(ST)的1年复合风险。纳入了6项试验,其中DES术后的DAPT由阿司匹林和氯吡格雷组成。在11473例随机分组的患者中,6714例(58.5%)患有稳定型冠心病,4758例(41.5%)表现为急性冠状动脉综合征(ACS),其中大多数(67.0%)为不稳定型心绞痛。在ACS患者中,与1年DAPT相比,≤6个月DAPT的1年MI或ST发生率略高,但无统计学意义(风险比(HR)1.48,95%置信区间(CI)0.98 - 2.22;P = 0.059),而在稳定型患者中,两种DAPT策略的MI和ST发生率相似(HR 0.93,95%CI 0.65 - 1.35;P = 0.71;P交互作用 = 0.09)。通过网络荟萃分析,3个月DAPT而非6个月DAPT与ACS患者中更高的MI或ST发生率相关,而在稳定型患者中无明显差异。与1年DAPT相比,短期DAPT的大出血发生率较低,与临床表现无关。稳定型冠心病和ACS患者中,短期与长期DAPT的全因死亡率无显著差异。

结论

DES置入术后的最佳DAPT持续时间因临床表现而异。在本荟萃分析中,尽管大多数纳入的ACS患者风险相对较低,但3个月DAPT与缺血风险增加相关,而3个月DAPT在稳定型冠心病中似乎是安全的。无论临床表现如何,延长DAPT都会增加出血风险。需要进一步研究以根据个体患者的相对缺血和出血风险确定DES置入术后DAPT的最佳持续时间。

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