全球领导者试验中患者及结局的地区差异

Regional variation in patients and outcomes in the GLOBAL LEADERS trial.

作者信息

Gao Chao, Takahashi Kuniaki, Garg Scot, Hara Hironori, Wang Rutao, Kawashima Hideyuki, Ono Masafumi, Montalescot Gilles, Haude Michael, Slagboom Ton, Vranckx Pascal, Valgimigli Marco, Windecker Stephan, Hamm Christian, Steg Philippe Gabriel, Storey Robert, van Geuns Robert-Jan, Tao Ling, Onuma Yoshinobu, Serruys Patrick W

机构信息

Department of Cardiology, Xijing hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland Galway, Galway, Ireland.

Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

出版信息

Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.

DOI:10.1016/j.ijcard.2020.09.039

PMID:32941872

Abstract

BACKGROUND

Despite the overall neutral results of the GLOBAL-LEADERS trial, results from a prespecified subgroup analysis showed that patients from Western Europe had a significantly lower rate of the primary endpoint when treated with ticagrelor monotherapy. Therefore, we aimed to examine the regional disparities in patients' baseline characteristics and their response to ticagrelor monotherapy.

METHODS

Patients' baseline characteristics and the treatment effects of ticagrelor combined with aspirin for 1 month, followed by ticagrelor monotherapy for 23-months versus 12-months of standard dual antiplatelet therapy (DAPT) were compared according to participating countries. The primary endpoint was a composite endpoint of all-cause death or new Q-wave myocardial infarction at two years.

RESULTS

Significant variances in patients' baseline characteristics were found between participating countries. The primary endpoint varied significantly according to the country (P = 0.027). Patients from France (1.6% versus 5.2%, HR: 0.31, 95%CI: 0.13-0.73) and The Netherlands (2.4% versus 4.8%, HR, 0.50, 95%CI: 0.26-0.94) had lower rates of the primary endpoint when allocated to ticagrelor monotherapy, compared with the standard DAPT regimen. Of the 26 baseline and post-randomization factors explored, variance in the rate of complex PCI between countries was identified as the top contributor to this regional interaction.

CONCLUSIONS

Patients' baseline characteristics varied between participating countries in the GLOBAL-LEADERS trial. There is a significant regional variance in the treatment effect of ticagrelor monotherapy, which could partly be explained by the differences in complex PCI being performed.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov (NCT01813435).

摘要

背景

尽管GLOBAL-LEADERS试验的总体结果呈中性，但一项预先设定的亚组分析结果显示，接受替格瑞洛单药治疗时，西欧患者的主要终点发生率显著较低。因此，我们旨在研究患者基线特征及其对替格瑞洛单药治疗反应的地区差异。

方法

根据参与国家，比较患者的基线特征以及替格瑞洛联合阿司匹林治疗1个月后，再接受23个月替格瑞洛单药治疗与接受12个月标准双联抗血小板治疗（DAPT）的治疗效果。主要终点是两年时全因死亡或新发Q波心肌梗死的复合终点。

结果

参与国家之间患者的基线特征存在显著差异。主要终点根据国家不同有显著差异（P = 0.027）。与标准DAPT方案相比，分配至替格瑞洛单药治疗的法国患者（1.6%对5.2%，HR：0.31，95%CI：0.13 - 0.73）和荷兰患者（2.4%对4.8%，HR：0.50，95%CI：0.26 - 0.94）的主要终点发生率较低。在探索的26个基线和随机分组后因素中，各国复杂PCI发生率的差异被确定为这种地区性相互作用的主要因素。