Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome

BackgroundWe evaluated optimal duration of dual antiplatelet therapy (DAPT) after second-generation drug-eluting stent (DES) implantation in acute coronary syndrome (ACS).Material and methodsFrom pooled analysis of three randomized clinical trials (EXCELLENT, IVUS-XPL, RESET), a total of 2,216 patient with ACS undergoing second-generation DES implantation were selected. Each study randomized patients to a short-duration DAPT arm (n = 1119; ≤6 months) or a standard-duration DAPT arm (n = 1097; ≥12 months). Two-thirds of patients were male, and their mean age was 63 years. Mean DAPT durations were 164 ±76 and 359 ±68 days, respectively. The primary endpoint was composite of cardiac death, myocardial infarction, stent thrombosis, stroke or major bleeding during the first 12 months after implantation, analyzed according to the intention-to-treat population.ResultsDemographic characteristics were balanced between groups. Mean DAPT duration was 164 and 359 days, respectively. Primary endpoint occurred in 22 patients with short-DAPT and 21 patients with standard-DAPT (2.0% versus 1.9%; hazard ratio [HR] 1.03; 95% confidence interval [CI] 0.56–1.86; p = 0.94). Landmark analysis after six-months, no significant difference in primary endpoint between short and standard duration DAPT (1.0% versus 0.8%; HR 1.22; 95% CI 0.51–2.95; p = 0.66).ConclusionsShort-duration DAPT (≤6 months) demonstrated a similar incidence of net adverse cardiovascular and clinical events at 12 months after second-generation DES in ACS compared with standard duration DAPT (≥12 months).Clinical trial registrationEXCELLENT (ClinicalTrials.gov, NCT00698607), RESET (ClinicalTrials.gov, NCT01145079), IVUS-XPL (ClinicalTrials.gov, NCT01308281)

背景 本研究旨在评估急性冠脉综合征（acute coronary syndrome, ACS）患者接受第二代药物洗脱支架（drug-eluting stent, DES）植入术后，双联抗血小板治疗（dual antiplatelet therapy, DAPT）的最优疗程。

材料与方法 本研究对三项随机临床试验（EXCELLENT、IVUS-XPL、RESET）进行合并分析，共纳入2216例接受第二代DES植入术的ACS患者。所有研究均将受试者随机分为短疗程DAPT组（n=1119；疗程≤6个月）与标准疗程DAPT组（n=1097；疗程≥12个月）。受试者中三分之二为男性，平均年龄63岁。两组患者的平均DAPT疗程分别为164±76天与359±68天。本研究的主要终点为植入术后前12个月内发生心脏死亡、心肌梗死、支架血栓形成、卒中或大出血的复合终点，采用意向性治疗（intention-to-treat, ITT）人群进行分析。

结果 两组患者的人口学特征均衡可比。两组平均DAPT疗程分别为164天与359天。短疗程DAPT组与标准疗程DAPT组分别有22例与21例患者发生主要终点事件（2.0% vs 1.9%；风险比[hazard ratio, HR] 1.03；95%置信区间[confidence interval, CI] 0.56–1.86；P=0.94）。6个月后行地标分析显示，短疗程与标准疗程DAPT组的主要终点事件发生率无显著差异（1.0% vs 0.8%；HR 1.22；95% CI 0.51–2.95；P=0.66）。

结论 与标准疗程DAPT（≥12个月）相比，短疗程DAPT（≤6个月）应用于ACS患者第二代DES植入术后，术后12个月时的净不良心血管与临床事件发生率相当。

临床试验注册 EXCELLENT（ClinicalTrials.gov, NCT00698607）、RESET（ClinicalTrials.gov, NCT01145079）、IVUS-XPL（ClinicalTrials.gov, NCT01308281）