Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial
Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial
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DOI：
10.4244/eij-d-21-00870
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发表时间：
2022-08-01
期刊：
影响因子：
6.2
通讯作者：
Serruys, Patrick W.
中科院分区：
文献类型：
--
作者：
Ono, Masafumi;Hara, Hironori;Serruys, Patrick W.
背景：经皮冠状动脉介入治疗（PCI）后第二年的最佳抗血小板策略仍不明确。
目的：我们旨在比较替格瑞洛单药治疗与阿司匹林单药治疗在PCI术后1年及之后的临床结果。
方法：这项对开放性、全方位、随机的全球领导者（GLOBAL LEADERS）试验的事后亚组分析，比较了1个月双重抗血小板治疗（DAPT）后23个月的替格瑞洛单药治疗与12个月DAPT后12个月的阿司匹林单药治疗，仅纳入在12个月时无缺血和出血事件且坚持所分配的抗血小板治疗的患者。比较了接受替格瑞洛或阿司匹林单药治疗的患者在第二年（12 - 24个月）缺血事件（全因死亡、任何心肌梗死或任何卒中）和出血事件（出血学术研究联合会[BARC] 3型或5型出血）的发生率。
结果：本分析纳入了全球领导者试验中15991名患者中的11121名（替格瑞洛单药治疗n = 5308，阿司匹林单药治疗n = 5813）。在第二年，与阿司匹林单药治疗相比，替格瑞洛单药治疗的缺血复合终点更低（1.9%对2.6%；对数秩检验p = 0.014，调整后的风险比[HR]为0.74，95%置信区间[CI]：0.58 - 0.96；p = 0.022），这主要是由于心肌梗死风险降低所致。相比之下，替格瑞洛单药治疗的BARC 3型或5型出血在数值上更高（0.5%对0.3%；对数秩检验p = 0.051，调整后的HR为1.89，95%CI：1.03 - 3.45；p = 0.005）。
结论：在PCI术后第一年结束时无事件且坚持规定方案的患者，与PCI术后第二年的阿司匹林单药治疗相比，缺血事件风险降低。
Background: The optimal antiplatelet strategy in the second year after percutaneous coronary intervention (PCI) remains unclear.Aims: We aimed to compare ticagrelor monotherapy with aspirin monotherapy on clinical outcomes be and 1 year post-PCI.Methods: This post hoc subanalysis of the open-label, all-corners, randomised GLOBAL LEADERS trial, which con pared 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) with 12-month aspirin monotherapy following 12-month DAPT, only included patients who, at 12 months, were free from ischaemic and bleeding events and were adherent to their assigned antiplatelet therapy. The incidences of ischaemic events (all-cause death, any myocardial infarction, or any stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) during the second year (12-24 months) were compared between patients receiving either ticagrelor or aspirin monotherapy.Results: The present analysis included 11,121 (ticagrelor monotherapy n=5,308, and aspirin monotherapy n=5,813) of the 15,991 patients enrolled in GLOBAL LEADERS. During the second year, the ischaemic composite endpoint was lower with ticagrelor monotherapy compared to aspirin monotherapy (1.9% vs 2.6%: log-rank p=0.014, adjusted hazard ratio [BR] 0.74, 95% confidence interval [CI]: 0.58-0.96; p=0.022), which was primarily driven by a reduced risk of myocardial infarction. In contrast, BARC type 3 or 5 bleeding was numerically higher with ticagrelor monotherapy (0.5% vs 0.3%: log-rank - 0.051, adjusted HR 1.89, 95% CI: 1.03-3.45; p=0.005).Conclusions: Patients free from events at the end of the first year post-PCI and who adhered to their prescribed regimen had a reduced risk of ischaemic events compared to aspirin monotherapy in the second year post-PCI.