Division of Cardiology, Chungju Medical Center, Chungju, South Korea.
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.
PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.
We evaluated optimal duration of dual antiplatelet therapy (DAPT) after second-generation drug-eluting stent (DES) implantation in acute coronary syndrome (ACS).
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.
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).
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).
EXCELLENT (ClinicalTrials.gov, NCT00698607), RESET (ClinicalTrials.gov, NCT01145079), IVUS-XPL (ClinicalTrials.gov, NCT01308281).
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。
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。
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）。
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。
EXCELLENT（ClinicalTrials.gov，NCT00698607），RESET（ClinicalTrials.gov，NCT01145079），IVUS-XPL（ClinicalTrials.gov，NCT01308281）。
