Extended Dual Antiplatelet Therapy for Multivessel Coronary Artery Disease.

Whether extending DAPT beyond 12 months in event-free patients with multivessel disease provides a benefit is uncertain.

在无事件发生的多支疾病患者中，将DAPT延长至超过12个月是否有益尚不确定。

Methods

We conducted an open-label, randomized trial at 97 centers in China.

我们在中国的97个中心进行了一项开放标签、随机试验。

Patients 18 to 75 years of age with multivessel coronary artery disease who had no major ischemic or bleeding events while receiving DAPT for 12 months after implantation of a drug-eluting stent were randomly assigned in a 1:1 ratio to receive an additional 12 months of DAPT (clopidogrel plus aspirin) or aspirin monotherapy.

在植入药物洗脱支架后，接受12个月双重抗血小板治疗（DAPT）期间没有发生重大缺血或出血事件的18至75岁多血管冠状动脉疾病患者，以1:1的比例随机分配，额外接受12个月的DAPT（氯吡格雷加阿司匹林）或阿司匹林单药治疗。

The primary efficacy end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

主要疗效终点是心血管原因死亡、非致命性心肌梗死或非致命性中风的复合终点。

The primary safety end point was clinically relevant or major bleeding (i.e., a bleeding event of Bleeding Academic Research Consortium [BARC] type ≥2; BARC types range from 0 to 5, with higher values indicating greater severity of bleeding).

主要安全性终点是临床相关或主要出血事件（即，出血事件为出血学术研究联盟[BARC]类型≥2；BARC类型从0到5，数值越高表示出血严重程度越大）。

Results

A total of 8250 patients were randomly assigned to receive extended DAPT (4125 patients) or aspirin monotherapy (4125 patients).

共有8250名患者被随机分配接受延长双联抗血小板治疗（DAPT）（4125名患者）或阿司匹林单药治疗（4125名患者）。

The median follow-up was 34.3 months.

中位随访时间为34.3个月。

A primary efficacy end-point event occurred in 222 patients in the DAPT group and in 266 patients in the aspirin-monotherapy group (36-month Kaplan-Meier cumulative incidence, 5.8% vs. 6.8%; hazard ratio, 0.82; 95% confidence interval[CI], 0.69 to 0.98; P = 0.03).

在DAPT组中有222名患者和在阿司匹林单药治疗组中有266名患者发生了主要疗效终点事件（36个月Kaplan-Meier累积发生率，5.8%对比6.8%；风险比，0.82；95%置信区间[CI]，0.69至0.98；P = 0.03）。

Clinically relevant or major bleeding occurred in 51 patients in the DAPT group and in 57 patients in the aspirin-monotherapy group (36-month Kaplan-Meier cumulative incidence, 1.4% vs. 1.5%; hazard ratio, 0.89; 95% CI, 0.61 to 1.30; P = 0.54).

在DAPT组中有51名患者和在阿司匹林单药治疗组中有57名患者发生了临床相关或主要出血事件（36个月Kaplan-Meier累积发生率，1.4%对比1.5%；风险比，0.89；95%置信区间[CI]，0.61至1.30；P = 0.54）。

Conclusions

Among patients with multivessel coronary artery disease who were in stable condition 12 months after implantation of a drug-eluting stent, extending DAPT with clopidogrel and aspirin for an additional 12 months led to a lower risk of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke than continuing aspirin alone, without an increased risk of bleeding.

在植入药物洗脱支架后12个月病情稳定的多支冠状动脉疾病患者中，将氯吡格雷和阿司匹林的双联抗血小板治疗（DAPT）延长12个月，与仅继续使用阿司匹林相比，心血管原因死亡、非致命性心肌梗死或非致命性中风的风险较低，且没有增加出血风险。

(Funded by the National Natural Science Foundation of China and others; DAPT-MVD ClinicalTrials.gov number, NCT04624854.).

(该研究由国家自然科学基金等资助；DAPT-MVD临床试验注册号为NCT04624854。)