接受复杂经皮冠状动脉介入治疗的患者在 1 个月双联抗血小板治疗后长期使用替格瑞洛单药治疗的影响：来自全球领导者试验的见解。

Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial.

机构信息

National Heart and Lung Institute, Imperial College London, Guy Scadding Building, Dovehouse St, Chelsea, London, UK.

Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands.

出版信息

Eur Heart J. 2019 Aug 14;40(31):2595-2604. doi: 10.1093/eurheartj/ehz453.

DOI:10.1093/eurheartj/ehz453

PMID:31397487

Abstract

AIMS

To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI).

METHODS AND RESULTS

In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011).

CONCLUSION

Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

摘要

目的

评估实验策略[1 个月双联抗血小板治疗（DAPT）后 23 个月替格瑞洛单药治疗]与参考方案（12 个月 DAPT 后 12 个月阿司匹林单药治疗）在复杂经皮冠状动脉介入治疗（PCI）后的影响。

方法和结果

在全球领导者试验的本次事后分析中，评估了复杂 PCI 患者的主要终点[全因死亡或新发 Q 波心肌梗死（MI）的复合终点]，复杂 PCI 包括以下至少一种特征：多血管 PCI、植入≥3 个支架、治疗≥3 个病变、分叉 PCI 中≥2 个支架或总支架长度>60mm。此外，还探讨了患者导向的复合终点（POCE）（全因死亡、任何卒中、任何 MI 或任何血运重建的复合终点）和净不良临床事件（NACE）[POCE 或出血学术研究联合会（BARC）3 型或 5 型出血的复合终点]。在这项分析中，纳入了 15450 名患者，其中 4570 名患者进行了复杂 PCI，他们发生缺血和出血事件的风险较高。在复杂 PCI 患者中，实验策略显著降低了主要终点[风险比（HR）：0.64，95%置信区间（CI）：0.48-0.85]和 POCE（HR：0.80，95% CI：0.69-0.93）的风险，但在非复杂 PCI 患者中没有降低（P 交互=0.015 和 0.017）。BARC 3 型或 5 型出血的风险相似（HR：0.97，95% CI：0.67-1.40），导致 NACE 显著降低（HR：0.80，95% CI：0.69-0.92；P 交互=0.011）。