急性冠脉综合征中第二代药物洗脱支架后 DAPT 的最佳持续时间。
Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome.
机构信息
Division of Cardiology, Chungju Medical Center, Chungju, South Korea.
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.
出版信息
PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.
BACKGROUND
We evaluated optimal duration of dual antiplatelet therapy (DAPT) after second-generation drug-eluting stent (DES) implantation in acute coronary syndrome (ACS).
MATERIAL AND METHODS
From 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.
RESULTS
Demographic 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).
CONCLUSIONS
Short-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 REGISTRATION
EXCELLENT (ClinicalTrials.gov, NCT00698607), RESET (ClinicalTrials.gov, NCT01145079), IVUS-XPL (ClinicalTrials.gov, NCT01308281).
背景
我们评估了急性冠脉综合征（ACS）患者接受第二代药物洗脱支架（DES）植入后双联抗血小板治疗（DAPT）的最佳持续时间。
材料与方法
从三项随机临床试验（EXCELLENT、IVUS-XPL、RESET）的汇总分析中，选择了 2216 例接受第二代 DES 植入的 ACS 患者。每项研究均将患者随机分配至短疗程 DAPT 组（n=1119；≤6 个月）或标准疗程 DAPT 组（n=1097；≥12 个月）。三分之二的患者为男性，平均年龄为 63 岁。平均 DAPT 持续时间分别为 164±76 天和 359±68 天。主要终点为植入后 12 个月内心脏死亡、心肌梗死、支架血栓形成、卒中和主要出血的复合终点，按意向治疗人群进行分析。
结果
两组之间的人口统计学特征平衡。平均 DAPT 持续时间分别为 164 天和 359 天。短疗程 DAPT 组和标准疗程 DAPT 组各有 22 例和 21 例发生主要终点事件（2.0%比 1.9%；风险比[HR]1.03；95%置信区间[CI]0.56-1.86；p=0.94）。6 个月后的 landmark 分析，短疗程 DAPT 和标准疗程 DAPT 的主要终点无显著差异（1.0%比 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，ACS 患者接受第二代 DES 植入后，短疗程 DAPT（≤6 个月）在 12 个月时的净不良心血管和临床事件发生率相似。
临床试验注册
EXCELLENT（ClinicalTrials.gov，NCT00698607），RESET（ClinicalTrials.gov，NCT01145079），IVUS-XPL（ClinicalTrials.gov，NCT01308281）。
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