替格瑞洛联合或不联合阿司匹林用于中国经皮冠状动脉介入治疗患者：TWILIGHT China 亚组研究。
Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy.
机构信息
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China (Y.H., G.W., Yi Li, L.B.).
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (B.E.C., R.G., S. Sartori, Z.Z., G.D., S. Sharma, U.B., R.M.).
出版信息
Circ Cardiovasc Interv. 2022 Apr;15(4):e009495. doi: 10.1161/CIRCINTERVENTIONS.120.009495. Epub 2022 Mar 23.
BACKGROUND
The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts.
METHODS
The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.
RESULTS
Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31-0.99]; =0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33-1.46]; =0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points.
CONCLUSIONS
Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT02270242.
背景
与非东亚患者相比，东亚经皮冠状动脉介入治疗（PCI）后双联抗血小板治疗的风险/获益权衡可能有所不同。
方法
双盲、安慰剂对照、随机 TWILIGHT 试验（替格瑞洛联合阿司匹林或单独用于高危 PCI 患者）纳入了接受高危 PCI 的患者。在替格瑞洛联合阿司匹林治疗 3 个月后，无事件且依从性良好的患者继续服用替格瑞洛，并随机分配接受阿司匹林或安慰剂治疗 1 年。主要终点为出血学术研究联合会（BARC）2、3 或 5 型出血；关键次要终点为任何原因导致的死亡、非致死性心肌梗死或非致死性卒中的首次发生。
结果
在 TWILIGHT 试验中，9006 名患者入选，7119 名患者随机分组，其中 1169 名（13.0%）患者在这项预设亚研究中入组了 27 家中国研究中心，其中 1028 名（14.4%）患者在 3 个月后随机分组。在随机分组至 1 年时，替格瑞洛+阿司匹林组的主要终点发生率为 6.2%，替格瑞洛+安慰剂组为 3.5%（风险比，0.56 [95%CI，0.31-0.99]；=0.048）。替格瑞洛+阿司匹林组的关键次要终点发生率为 3.4%，替格瑞洛+安慰剂组为 2.4%（风险比，0.70 [95%CI，0.33-1.46]；=0.34）。随机治疗分配与随机分组区域（中国与世界其他地区）之间无交互作用，主要或关键次要终点均如此。
结论
与替格瑞洛+阿司匹林相比，替格瑞洛单药治疗可显著降低中国高危 PCI 患者的临床相关出血，而不增加缺血事件。
登记
网址：https://www.
临床试验
gov；独特识别码：NCT02270242。
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