ST段抬高型心肌梗死的替卡格雷单药治疗:来自 TICO 和 T-PASS 试验的单个患者水平荟萃分析。

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Med Pub Date : 2024-08-10 DOI:10.1016/j.medj.2024.07.019
Yong-Joon Lee, Deok-Kyu Cho, Jun-Won Lee, Sanghoon Shin, Sung Woo Kwon, Yongsung Suh, Tae Soo Kang, Jong-Kwan Park, Jang-Whan Bae, Woong Cheol Kang, Seunghwan Kim, Seung-Jun Lee, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang, Kyeong Ho Yun, Myeong-Ki Hong
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引用次数: 0

摘要

背景:在评估短期双联抗血小板疗法(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:方法:从纳入接受药物洗脱支架(DES)植入术的 STEMI 患者的随机临床试验中汇集患者的个体数据,并比较短期(≤3 个月)DAPT 后替卡格雷单药治疗与基于替卡格雷的 12 个月 DAPT 在中央裁定的临床结果方面的差异。共同主要结果是1年的疗效结果(全因死亡、心肌梗死或中风的复合结果)和安全性结果(出血学术研究联合会3型或5型出血):汇总队列中有2253名STEMI患者。替卡格雷单药治疗组与基于替卡格雷的DAPT治疗组的主要疗效结局发生率没有差异(1.8%对2.0%;危险比[HR]=0.88;95%置信区间[CI]=0.49-1.61;P=0.684)。两组间心脏性死亡的发生率没有差异(0.6% 对 0.7%;HR = 0.89;95% CI = 0.32-2.46;P = 0.822)。替卡格雷单药治疗组的主要安全性结局发生率显著较低(2.3%对4.0%;HR = 0.56;95% CI = 0.35-0.92;P = 0.020)。在不同亚组的主要结果中,未观察到治疗效果的异质性:结论:在接受DES植入治疗的STEMI患者中,与基于替卡格雷的12个月DAPT相比,短期DAPT后替卡格雷单药治疗与较低的大出血相关,且不会增加缺血事件的风险。有必要开展进一步研究,将这些发现推广到非亚洲患者:本研究由Biotronik公司(瑞士比拉赫)资助。
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Ticagrelor monotherapy in ST-elevation myocardial infarction: An individual patient-level meta-analysis from TICO and T-PASS trials.

Background: 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).

Methods: 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.

Findings: 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.

Conclusions: 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.

Funding: This study was funded by Biotronik (Bülach, Switzerland).

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来源期刊
Med
Med MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
17.70
自引率
0.60%
发文量
102
期刊介绍: Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.
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