Objective: To compare the efficacy and safety of prolonged dual antiplatelet therapy (DAPT>1 year) in patients with stable coronary artery disease (CAD) and diabetes who were event-free at 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) in a large and contemporary PCI registry. Methods: A total of 1 661 eligible patients were selected from the Fuwai PCI Registry, of which 1 193 received DAPT>1 year and 468 received DAPT ≤1 year. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE) and Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding, MACCE was defined as a composite of all-cause death, myocardial infarction or stroke. Multivariate Cox regression analysis and inverse probability of treatment weighting (IPTW) Cox regression analysis were performed. Results: After a median follow-up of 2.5 years, patients who received DAPT>1 year were associated with lower risks of MACCE (1.4% vs. 3.2%; hazard ratio (HR) 0.412, 95% confidence interval (CI) 0.205-0.827) compared with DAPT ≤1 year, which was primarily caused by the lower all-cause mortality (0.1% vs. 2.6%; HR 0.031, 95%CI 0.004-0.236). Risks of cardiac death (0.1% vs. 1.5%; HR 0.051, 95%CI 0.006-0.416) and definite/probable ST (0.3% vs. 1.1%; HR 0.218, 95%CI 0.052-0.917) were also lower in patients received DAPT>1 year than those received DAPT ≤ 1 year. No difference was found between the two groups in terms of BARC type 2, 3, or 5 bleeding (5.3% vs. 4.1%; HR 1.088, 95%CI 0.650-1.821). Conclusions: In patients with stable CAD and diabetes who were event-free at 1 year after PCI with DES, prolonged DAPT (>1 year) provides a substantial reduction in ischemic cardiovascular events, including MACCE, all-cause mortality, cardiac mortality, and definite/probable ST, without increasing the clinically relevant bleeding risk compared with ≤ 1-year DAPT. Further well-designed, large-scale randomized trials are needed to verify the beneficial effect of prolonged DAPT in this population.
目的： 探讨稳定性冠心病合并糖尿病患者中，延长双联抗血小板治疗（dual antiplatelet therapy，DAPT）对置入药物洗脱支架（drug-eluting stent，DES）后心血管事件和出血事件的影响。 方法： 本研究为单中心、观察性研究，入选中国医学科学院阜外医院收治的稳定性冠心病合并糖尿病置入DES，且1年内无心血管事件和临床相关出血事件发生的患者1 661例。根据患者1年后是否继续接受DAPT（阿司匹林+氯吡格雷），将患者分为DAPT>1年组（n=1 193）和DAPT ≤1年组（n=468），并进行远期随访。主要终点为主要不良心脑血管事件（major adverse cardiac and cerebrovascular event，MACCE）和出血学术研究会（Bleeding Academic Research Consortium，BARC）定义的2、3或5型出血。 结果： 中位随访时间为2.5年。相对于DAPT≤1年组，DAPT>1年组MACCE风险更低（1.4%比3.2%；HR 0.412，95%CI 0.205~0.827），这一结果主要由DAPT>1年组全因死亡率更低所致（0.1%比2.6%；HR 0.031，95%CI 0.004~0.236）。此外，DAPT>1年组2.5年的心原性死亡（0.1%比1.5%；HR 0.051，95%CI 0.006~0.416）和明确的/很可能的支架内血栓（0.3%比1.1%；HR 0.218，95%CI 0.052~0.917）风险也更低，而两组间的BARC 2、3或5型出血风险（5.3%比4.1%；HR 1.088，95%CI 0.650~1.821）差异无统计学意义。Cox多因素回归分析和逆概率加权法回归分析也得到了类似的结果。 结论： 在稳定性冠心病合并糖尿病患者中，置入DES后阿司匹林联合氯吡格雷的DAPT持续1年以上可减少患者的缺血事件风险，而不增加临床相关出血风险。但研究结果需大样本量的随机对照研究来证实。.