Baber Usman, Cao Davide, Collier Timothy, Sartori Samantha, Dangas George, Angiolillo Dominick J, Vogel Birgit, Kunadian Vijay, Briguori Carlo, Cohen David J, Dudek Dariusz, Gibson C Michael, Gil Robert, Huber Kurt, Kaul Upendra, Kornowski Ran, Krucoff Mitchell W, Mehta Shamir, Moliterno David J, Ohman E Magnus, Escaned Javier, Sardella Gennaro, Sharma Samin K, Shlofmitz Richard, Weisz Giora, Witzenbichler Bernhard, Steg P Gabriel, Pocock Stuart, Mehran Roxana
Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, NY 10029, USA.
Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):66-74. doi: 10.1093/ehjcvp/pvae080.
In standard time-to-first event analysis, early aspirin discontinuation followed by ticagrelor monotherapy has been shown to reduce bleeding without increasing ischaemic complications compared with ticagrelor plus aspirin after percutaneous coronary intervention (PCI). We evaluated whether these treatment effects are preserved when recurrent events are considered.
In this TWILIGHT trial post-hoc analysis, we assessed the effects of ticagrelor monotherapy on the total number of events that occurred over the 12-month follow-up among 7119 high-risk patients randomized to aspirin or placebo in addition to ticagrelor at 3 months post-PCI if event-free and adherent to treatment. There were 391 patients with at least one Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (primary endpoint). Of those, 28 (7.2%) had a recurrent event. The total number of BARC 2, 3, or 5 bleeding events was 148 in the ticagrelor monotherapy arm compared with 278 with ticagrelor plus aspirin arm (P < 0.001). Among 272 patients with at least one key secondary ischaemic endpoint (all-cause death, myocardial infarction, or stroke), 37 (13.6%) sustained a recurrent event. Total ischaemic events were similar (155 vs. 159) in the two groups.
Among selected high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy followed by ticagrelor with or without aspirin, recurrent bleeding was less common than recurrent ischaemic events over 12 months. Analysis of total events indicates that ticagrelor monotherapy continues to be more effective than ticagrelor plus aspirin in reducing bleeding without a signal of ischaemic harm.
在标准的首次事件发生时间分析中，与经皮冠状动脉介入治疗（PCI）后替格瑞洛加阿司匹林相比，早期停用阿司匹林继以替格瑞洛单药治疗已显示可减少出血且不增加缺血性并发症。我们评估了在考虑复发事件时这些治疗效果是否依然存在。
在这项TWILIGHT试验的事后分析中，我们评估了替格瑞洛单药治疗对7119例高危患者在PCI术后3个月时随机接受阿司匹林或安慰剂加替格瑞洛治疗（如果无事件且坚持治疗）的12个月随访期间发生的事件总数的影响。有391例患者至少发生1次出血学术研究联盟（BARC）2、3或5型出血（主要终点）。其中，28例（7.2%）发生了复发事件。替格瑞洛单药治疗组的BARC 2、3或5型出血事件总数为148例，而替格瑞洛加阿司匹林组为278例（P<0.001）。在272例至少发生1次关键次要缺血性终点（全因死亡、心肌梗死或卒中）的患者中，37例（13.6%）发生了复发事件。两组的总缺血事件相似（155例对159例）。
在接受PCI并完成3个月双联抗血小板治疗后接受替格瑞洛联合或不联合阿司匹林治疗的选定高危患者中，12个月内复发性出血比复发性缺血事件少见。对总事件的分析表明，替格瑞洛单药治疗在减少出血方面继续比替格瑞洛加阿司匹林更有效，且无缺血性损害信号。
