替格瑞洛单药治疗与替格瑞洛联合阿司匹林用于慢性冠状动脉综合征且缺血风险高的患者：TWILIGHT试验的事后分析
Ticagrelor monotherapy versus ticagrelor plus aspirin in patients with chronic coronary syndrome and high ischaemic risk: a post hoc analysis of the TWILIGHT trial.
作者信息
Gitto Mauro, Baber Usman, Sartori Samantha, Vogel Birgit, Angiolillo Dominick J, Briguori Carlo, Cohen David J, Collier Timothy, Dudek Dariusz, Oliva Angelo, Escaned Javier, Feng Yihan, Gibson C Michael, Han Ya-Ling, Di Muro Francesca Maria, Shlofmitz Richard A, Huber Kurt, Steg Philippe Gabriel, Sharma Samin, Sardella Gennaro, Kastrati Adnan, Kaul Upendra, Kornowski Ran, Kunadian Vijay, Stefanini Giulio G, Mehta Shamir R, Dangas George, Mehran Roxana
机构信息
Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
IRCCS Humanitas Research Hospital, Rozzano, Italy.
出版信息
EuroIntervention. 2025 May 16;21(10):550-559. doi: 10.4244/EIJ-D-24-00973.
BACKGROUND
Short dual antiplatelet therapy (DAPT) followed by ticagrelor monotherapy may be a valuable therapeutic option for patients with chronic coronary syndrome (CCS) and high ischaemic risk (HIR) undergoing percutaneous coronary intervention (PCI).
AIMS
We aimed to compare ticagrelor monotherapy with ticagrelor-based DAPT in CCS patients with and without HIR undergoing PCI.
METHODS
The present analysis included the CCS cohort of the TWILIGHT trial, which randomised PCI patients to ticagrelor alone or in combination with aspirin for 12 months after 3 months of ticagrelor-based DAPT. Patients were stratified into HIR and non-HIR based on the 2019 European Society of Cardiology (ESC) CCS guidelines definition. Outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction or stroke, and Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding at 1 year.
RESULTS
Of the 2,503 CCS patients who underwent randomisation, the ESC definition classified 1,264 (50.5%) as HIR and 1,239 (49.5%) as non-HIR. HIR patients displayed a higher risk of MACCE (3.9% vs 2.3%; p=0.015) and similar rates of BARC Type 2-5 bleeding (5.1% vs 5.7%; p=0.455) as compared to non-HIR patients. Ticagrelor monotherapy and ticagrelor-based DAPT were associated with similar risks of MACCE (HIR: 4.0% vs 3.8%, hazard ratio [HR] 1.06, 95% confidence interval [CI]: 0.60-1.85; non-HIR: 2.1% vs 2.6%, HR 0.80, 95% CI: 0.38-1.66, p=0.553) and bleeding (HIR: 4.7% vs 5.7%, HR 0.82, 95% CI: 0.50-1.33; non-HIR: 4.9% vs 6.7%, HR 0.71, 95% CI: 0.44-1.14; p=0.684) in both the HIR and non-HIR groups.
CONCLUSIONS
In a post hoc analysis of the TWILIGHT trial that included CCS patients undergoing PCI, ticagrelor monotherapy after 3 months of DAPT appeared to be safe and was not associated with increased risks of ischaemic or bleeding events, regardless of baseline HIR status, compared with standard ticagrelor-based DAPT. These findings suggest the potential to expand guideline recommendations for ticagrelor monotherapy in CCS.
背景
对于接受经皮冠状动脉介入治疗（PCI）的慢性冠状动脉综合征（CCS）且缺血风险高（HIR）的患者，短期双联抗血小板治疗（DAPT）后继以替格瑞洛单药治疗可能是一种有价值的治疗选择。
目的
我们旨在比较接受PCI的有和没有HIR的CCS患者中，替格瑞洛单药治疗与基于替格瑞洛的DAPT的疗效。
方法
本分析纳入了TWILIGHT试验的CCS队列，该试验将PCI患者在接受3个月基于替格瑞洛的DAPT后，随机分为单独使用替格瑞洛或与阿司匹林联合使用12个月。根据2019年欧洲心脏病学会（ESC）CCS指南定义，将患者分为HIR和非HIR。感兴趣的结局是主要不良心脑血管事件（MACCE），即死亡、心肌梗死或中风的复合结局，以及1年时的出血学术研究联盟（BARC）2 - 5型出血。
结果
在2503例接受随机分组的CCS患者中，根据ESC定义，1264例（50.5%）为HIR，1239例（49.5%）为非HIR。与非HIR患者相比，HIR患者发生MACCE的风险更高（3.9%对2.3%；p = 0.015），而BARC 2 - 5型出血的发生率相似（5.1%对5.7%；p = 0.455）。在HIR和非HIR组中，替格瑞洛单药治疗和基于替格瑞洛的DAPT发生MACCE的风险相似（HIR：4.0%对3.8%，风险比[HR] 1.06，95%置信区间[CI]：0.60 - 1.85；非HIR：2.1%对2.6%，HR 0.80，95% CI：0.38 - 1.66，p = 0.553），出血风险也相似（HIR：4.7%对5.7%，HR 0.82，95% CI：0.50 - 1.33；非HIR：4.9%对6.7%，HR 0.71，95% CI：0.44 - 1.14；p = 0.684）。
结论
在一项对包括接受PCI的CCS患者的TWILIGHT试验的事后分析中，与标准的基于替格瑞洛的DAPT相比，DAPT 3个月后使用替格瑞洛单药治疗似乎是安全的，且与缺血或出血事件风险增加无关，无论基线HIR状态如何。这些发现提示了扩大CCS中替格瑞洛单药治疗指南推荐的可能性。
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