Win statistics offer a new approach to the analysis of outcomes in clinical trials, allowing the combination of time-to-event and longitudinal measurements and taking into account the clinical importance of the components of composite outcomes, as well as their relative timing. We examined this approach in a post hoc analysis of two trials that compared dapagliflozin to placebo in patients with heart failure and reduced ejection fraction (DAPA-HF) and mildly reduced or preserved ejection fraction (DELIVER). The effect of dapagliflozin on a hierarchical composite kidney outcome was assessed, including the following: (1) all-cause mortality; (2) end-stage kidney disease; (3) a decline in estimated glomerular filtration rate (eGFR) of ≥57%; (4) a decline in eGFR of ≥50%; (5) a decline in eGFR of ≥40%; and (6) participant-level eGFR slope. For this outcome, the win ratio was 1.10 (95% confidence interval (CI) = 1.06–1.15) in the combined dataset, 1.08 (95% CI = 1.01–1.16) in the DAPA-HF trial and 1.12 (95% CI = 1.05–1.18) in the DELIVER trial; that is, dapagliflozin was superior to placebo in both trials. The benefits of treatment were consistent in participants with and without baseline kidney disease, and with and without type 2 diabetes. In heart failure trials, win statistics may provide the statistical power to evaluate the effect of treatments on kidney as well as cardiovascular outcomes.

获胜统计为临床试验结果分析提供了一种新方法，允许将事件发生时间和纵向测量相结合，并考虑复合结果组成部分的临床重要性及其相对时间。我们在两项试验的事后分析中检查了这种方法，这两项试验将达格列净与安慰剂在射血分数降低（DAPA-HF）和射血分数轻度降低或保留（DELIVER）心力衰竭患者中进行比较。评估了达格列净对分级复合肾脏结局的影响，包括以下内容：（1）全因死亡率； (2)终末期肾病； (3)估计肾小球滤过率(eGFR)下降≥57%； (4) eGFR下降≥50%； (5) eGFR下降≥40%； (6) 参与者水平的 eGFR 斜率。对于这一结果，合并数据集中的获胜率为 1.10（95% 置信区间 (CI) = 1.06–1.15），DAPA-HF 试验中的获胜率为 1.08（95% CI = 1.01–1.16），而 DAPA-HF 试验的获胜率为 1.12（95% CI = 1.06–1.15）。 1.05–1.18) 在 DELIVER 试验中；也就是说，达格列净在两项试验中均优于安慰剂。对于患有和不患有基线肾脏疾病、患有和不患有 2 型糖尿病的参与者来说，治疗的益处是一致的。在心力衰竭试验中，获胜统计数据可以提供统计能力来评估治疗对肾脏和心血管结局的影响。