糖尿病患者药物洗脱支架植入术后延长双联抗血小板治疗：一项全国性回顾性队列研究。
Prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with diabetes mellitus: A nationwide retrospective cohort study.
作者信息
Lee Seung-Jun, Choi Dong-Woo, Kim Choongki, Suh Yongsung, Hong Sung-Jin, Ahn Chul-Min, Kim Jung-Sun, Kim Byeong-Keuk, Ko Young-Guk, Choi Donghoon, Park Eun-Cheol, Jang Yangsoo, Nam Chung-Mo, Hong Myeong-Ki
机构信息
Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, South Korea.
出版信息
Front Cardiovasc Med. 2022 Aug 11;9:954704. doi: 10.3389/fcvm.2022.954704. eCollection 2022.
BACKGROUND
Optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) who have undergone drug-eluting stent (DES) implantation is not clearly established. This study sought to impact of DAPT duration on real-world clinical outcome in patients with or without DM.
METHODS
Using a nationwide cohort database, we investigate the association between DAPT duration and clinical outcome between 1 and 3 years after percutaneous coronary intervention (PCI). Primary outcome was all-cause death. Secondary outcomes were cardiovascular death, myocardial infarction, and composite bleeding events. After weighting, 90,100 DES-treated patients were included; 29,544 patients with DM and 60,556 without DM; 31,233 patients with standard DAPT (6-12 months) and 58,867 with prolonged DAPT (12-24 months).
RESULTS
The incidence of all-cause death was significantly lower in patients with prolonged DAPT [8.3% vs. 10.5% in those with standard DAPT, hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.72-0.84] in diabetic patients and non-diabetic patients (4.5% vs. 5.0% in those with standard DAPT, HR 0.89, 95% CI 0.83-0.96). The incidence of composite bleeding events was 5.7% vs. 5.4%, respectively, (HR 1.07, 95% CI 0.96-1.18) in diabetic patients and 5.6% vs. 5.0%, respectively, in non-diabetic patients (HR 1.13, 95% CI 1.05-1.21). There was a significant interaction between the presence of DM and DAPT duration for all-cause death (p for interaction, p = 0.01) that further favored prolonged DAPT in diabetic patients. However, there was no significant interaction between the presence of DM and DAPT duration for composite bleeding events (p = 0.38).
CONCLUSIONS
This study showed that prolonged rather than standard DAPT might be clinically beneficial in diabetic patients with DES implantation.
TRIAL REGISTRATION
ClinicalTrial.gov (NCT04715594).
背景
糖尿病（DM）患者植入药物洗脱支架（DES）后双联抗血小板治疗（DAPT）的最佳持续时间尚未明确确定。本研究旨在探讨DAPT持续时间对有或无DM患者实际临床结局的影响。
方法
利用全国性队列数据库，我们调查了经皮冠状动脉介入治疗（PCI）后1至3年DAPT持续时间与临床结局之间的关联。主要结局是全因死亡。次要结局是心血管死亡、心肌梗死和复合出血事件。加权后，纳入了90100例接受DES治疗的患者；29544例DM患者和60556例非DM患者；31233例接受标准DAPT（6 - 12个月）的患者和58867例接受延长DAPT（12 - 24个月）的患者。
结果
在糖尿病患者和非糖尿病患者中，延长DAPT组的全因死亡发生率均显著低于标准DAPT组（糖尿病患者中分别为8.3%和10.5%，风险比（HR）0.78，95%置信区间（CI）0.72 - 0.84；非糖尿病患者中分别为4.5%和5.0%，HR 0.89，95% CI 0.83 - 0.96）。糖尿病患者复合出血事件的发生率分别为5.7%和5.4%（HR 1.07，95% CI 0.96 - 1.18），非糖尿病患者分别为5.6%和5.0%（HR 1.13，95% CI 1.05 - 1.21）。在全因死亡方面，DM的存在与DAPT持续时间之间存在显著交互作用（交互作用p值，p = 0.01），这进一步表明延长DAPT对糖尿病患者更有利。然而，在复合出血事件方面，DM的存在与DAPT持续时间之间没有显著交互作用（p = 0.38）。
结论
本研究表明，对于植入DES的糖尿病患者，延长而非标准DAPT可能在临床上有益。
试验注册
ClinicalTrial.gov（NCT04715594）。
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