Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Can J Cardiol. 2024 Nov;40(11):2171-2179. doi: 10.1016/j.cjca.2024.07.002. Epub 2024 Jul 14.
Win ratio (WR) is a newer analytic approach for trials with composite end points that accounts for the relative importance of individual components. Our objective was to compare the results of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial analyzed using WR with those obtained using conventional statistical approaches.
We used an unmatched WR analysis for first and total (first plus recurrent) events to examine effects of rivaroxaban with aspirin and rivaroxaban alone vs aspirin alone on primary efficacy (cardiovascular death, stroke, myocardial infarction), safety (modified International Society on Thrombosis and Haemostasis major bleeding), and net clinical benefit (primary efficacy plus fatal or critical organ bleeding) end points. We compared the WR results with those obtained using the Cox proportional hazards regression model for first events and Anderson-Gill method for total events. We calculated the win difference to estimate absolute treatment effects.
The WR approach produced results consistent with those obtained using conventional statistical methods for the primary composite end point (first event: WR, 1.32 [95% confidence interval (CI), 1.14-1.52]; 1/Cox hazard ratio, 1.32 [95% CI, 1.16-1.52]; total [first plus recurrent] events: WR, 1.32 [95% CI, 1.14-1.52]; 1/Anderson-Gill hazard ratio, 1.32 [95% CI, 1.16-1.54]) as well as for main safety and net clinical benefit end points. The absolute benefits of the combination of rivaroxaban and aspirin compared with aspirin alone calculated using the win difference were greatest in those with multiple high-risk features.
Reanalysis of the COMPASS trial results using WR produced results that were consistent with those obtained using conventional statistical approaches.
NCT01776424.
胜率（WR）是一种分析复合终点试验的新方法，可考虑各组成部分的相对重要性。我们的目的是比较使用胜率（WR）分析和传统统计学方法分析心血管结局的抗凝策略（COMPASS）试验的结果。
我们使用未配对的 WR 分析首次和总（首次加复发）事件，以评估利伐沙班联合阿司匹林与阿司匹林单独使用对主要疗效（心血管死亡、中风、心肌梗死）、安全性（改良国际血栓与止血协会大出血）和净临床获益（主要疗效加致死性或关键器官出血）终点的影响。我们将 WR 结果与首次事件 Cox 比例风险回归模型和总事件 Anderson-Gill 方法的结果进行比较。我们计算了赢差来估计绝对治疗效果。
WR 方法得到的主要复合终点（首次事件：WR，1.32[95%置信区间（CI），1.14-1.52]；Cox 危险比，1.32[95% CI，1.16-1.52]；总[首次加复发]事件：WR，1.32[95% CI，1.14-1.52]；Anderson-Gill 危险比，1.32[95% CI，1.16-1.54]）和主要安全性及净临床获益终点的结果与传统统计学方法一致。使用赢差计算的利伐沙班联合阿司匹林与阿司匹林单独使用相比的绝对获益在具有多种高危特征的患者中最大。
使用 WR 重新分析 COMPASS 试验结果得到的结果与传统统计学方法一致。
NCT01776424。
