Lee Yong-Joon, Cho Deok-Kyu, Lee Jun-Won, Shin Sanghoon, Kwon Sung Woo, Suh Yongsung, Kang Tae Soo, Park Jong-Kwan, Bae Jang-Whan, Kang Woong Cheol, Kim Seunghwan, Lee Seung-Jun, Hong Sung-Jin, Ahn Chul-Min, Kim Jung-Sun, Kim Byeong-Keuk, Ko Young-Guk, Choi Donghoon, Jang Yangsoo, Yun Kyeong Ho, Hong Myeong-Ki
Department of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Korea.
Med. 2024 Dec 13;5(12):1466-1474.e2. doi: 10.1016/j.medj.2024.07.019. Epub 2024 Aug 16.
Patients with ST-elevation myocardial infarction (STEMI) tend to be excluded or under-represented in randomized clinical trials evaluating the effects of potent P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy (DAPT).
Individual patient data were pooled from randomized clinical trials that included STEMI patients undergoing drug-eluting stent (DES) implantation and compared ticagrelor monotherapy after short-term (≤3 months) DAPT versus ticagrelor-based 12-month DAPT in terms of centrally adjudicated clinical outcomes. The co-primary outcomes were efficacy outcome (composite of all-cause death, myocardial infarction, or stroke) and safety outcome (Bleeding Academic Research Consortium type 3 or 5 bleeding) at 1 year.
The pooled cohort contained 2,253 patients with STEMI. The incidence of the primary efficacy outcome did not differ between the ticagrelor monotherapy group and the ticagrelor-based DAPT group (1.8% versus 2.0%; hazard ratio [HR] = 0.88; 95% confidence interval [CI] = 0.49-1.61; p = 0.684). There was no difference in cardiac death between the groups (0.6% versus 0.7%; HR = 0.89; 95% CI = 0.32-2.46; p = 0.822). The incidence of the primary safety outcome was significantly lower in the ticagrelor monotherapy group (2.3% versus 4.0%; HR = 0.56; 95% CI = 0.35-0.92; p = 0.020). No heterogeneity of treatment effects was observed for the primary outcomes across subgroups.
In patients with STEMI treated with DES implantation, ticagrelor monotherapy after short-term DAPT was associated with lower major bleeding without an increase in the risk of ischemic events compared with ticagrelor-based 12-month DAPT. Further research is necessary to extend these findings to non-Asian patients.
This study was funded by Biotronik (Bülach, Switzerland).
在评估短期双联抗血小板治疗(DAPT)后强效P2Y12抑制剂单药治疗效果的随机临床试验中,ST段抬高型心肌梗死(STEMI)患者往往被排除在外或代表性不足。
汇总来自随机临床试验的个体患者数据,这些试验纳入了接受药物洗脱支架(DES)植入的STEMI患者,并比较了短期(≤3个月)DAPT后替格瑞洛单药治疗与基于替格瑞洛的12个月DAPT在中心判定的临床结局方面的差异。共同主要结局为1年时的疗效结局(全因死亡、心肌梗死或卒中的复合结局)和安全性结局(出血学术研究联盟3型或5型出血)。
汇总队列包含2253例STEMI患者。替格瑞洛单药治疗组和基于替格瑞洛的DAPT组的主要疗效结局发生率无差异(1.8%对2.0%;风险比[HR]=0.88;95%置信区间[CI]=0.49 - 1.61;p=0.684)。两组间心源性死亡无差异(0.6%对0.7%;HR=0.89;95% CI=0.32 - 2.46;p=0.822)。替格瑞洛单药治疗组的主要安全性结局发生率显著更低(2.3%对4.0%;HR=0.56;95% CI=0.35 - 0.92;p=0.020)。各亚组的主要结局未观察到治疗效果的异质性。
在接受DES植入治疗的STEMI患者中,与基于替格瑞洛的12个月DAPT相比,短期DAPT后替格瑞洛单药治疗与更低的大出血发生率相关,且缺血事件风险未增加。有必要进一步开展研究,将这些发现扩展至非亚洲患者。
本研究由百多力公司(瑞士比拉赫)资助。