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‘Ticagrelor alone vs. dual antiplatelet therapy from 1 month after drug-eluting coronary stenting among patients with STEMI’: a post hoc analysis of the randomized GLOBAL LEADERS trial
European Heart Journal - Acute Cardiovascular Care ( IF 3.9 ) Pub Date : 2021-05-06 , DOI: 10.1093/ehjacc/zuab033
Amr S Gamal 1, 2, 3 , Hironori Hara 1, 4 , Mariusz Tomaniak 5, 6 , Mattia Lunardi 1, 7 , Chao Gao 1, 8 , Masafumi Ono 1, 4 , Hideyuki Kawashima 1, 4 , Peter Jüni 9 , Pascal Vranckx 10 , Stephan Windecker 11 , Christian Hamm 12 , Philippe Gabriel Steg 13 , Yoshinobu Onuma 1 , Patrick W Serruys 1, 14
Affiliation  

Aim To evaluate the efficacy and safety of ticagrelor monotherapy beyond 1 month and up to 24 months vs. standard 12-month dual antiplatelet therapy (DAPT) with aspirin and ticagrelor followed by aspirin monotherapy among ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) in the GLOBAL LEADERS trial. Methods and results We performed a post hoc analysis of STEMI patients in the GLOBAL LEADERS trial comparing experimental ticagrelor monotherapy (1062 patients) with standard 12-month DAPT (1030 patients). We evaluated predefined primary and secondary endpoints in both treatment arms. Rates of net adverse clinical events (NACE), patient-oriented composite endpoints (POCE), and bleeding academic research consortium (BARC)-defined bleeding Type 3 or 5 were also evaluated. At 2 years, there were no significant differences in rates of primary endpoints in patients who had STEMI [0.89 (0.61–1.31)]. There were similar rates of NACE and POCE in both experimental and reference treatment groups at 2 years post-PCI [hazard ratio (HR) 0.96 (0.77–1.20) and 0.96 (0.77–1.21), respectively]. BARC 3 or 5 bleeding events were numerically less in experimental compared to reference treatment groups at 1 year [HR 0.55 (0.27–1.13)] and 2 years [0.61 (0.32–1.16)]. Conclusion Presentation with STEMI has not influenced the incidence of GLOBAL LEADERS defined primary endpoints. There were no significant differences in rates of NACE, POCE, and BARC bleeding between the two treatment groups up to 2 years of follow-up. Although these findings should be viewed as exploratory, they expand the evidence on potential safety of aspirin-free antiplatelet strategies after PCI in STEMI.

中文翻译:

“STEMI 患者药物洗脱冠状动脉支架术后 1 个月单独使用替格瑞洛与双重抗血小板治疗”:随机 GLOBAL LEADERS 试验的事后分析

目的 评估替格瑞洛单药治疗超过 1 个月至 24 个月与标准 12 个月阿司匹林和替格瑞洛双联抗血小板治疗(DAPT)继以阿司匹林单药治疗在 ST 段抬高型心肌梗死(STEMI)经皮治疗患者中的疗效和安全性全球领导者试验中的冠状动脉介入治疗(PCI)。方法和结果 我们对 GLOBAL LEADERS 试验中的 STEMI 患者进行了事后分析,比较了实验性替格瑞洛单药治疗(1062 名患者)与标准 12 个月 DAPT(1030 名患者)。我们评估了两个治疗组中预定义的主要和次要终点。还评估了净不良临床事件 (NACE)、以患者为导向的复合终点 (POCE) 和出血学术研究联盟 (BARC) 定义的 3 型或 5 型出血的发生率。2岁时,STEMI 患者的主要终点发生率没有显着差异 [0.89 (0.61–1.31)]。PCI 后 2 年,实验组和参考治疗组的 NACE 和 POCE 发生率相似[风险比 (HR) 分别为 0.96 (0.77-1.20) 和 0.96 (0.77-1.21)]。与参考治疗组相比,BARC 3 或 5 次出血事件在 1 年 [HR 0.55 (0.27–1.13)] 和 2 年 [0.61 (0.32–1.16)] 时在数值上较少。结论 STEMI 的表现不影响全球领导者定义的主要终点的发生率。在长达 2 年的随访中,两个治疗组的 NACE、POCE 和 BARC 出血率没有显着差异。尽管这些发现应该被视为探索性的,
更新日期:2021-05-06
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