采用优势比分析 PARAGON-HF 研究结果。
Analysis of the PARAGON-HF Study Results Using Win Ratio.
机构信息
Cardiovascular Center, Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea (M.Y., J.J.P.).
Department of Mathematical Sciences and RIMS, Seoul National University, Republic of Korea (W. Kim, W. Kook).
出版信息
Circ Heart Fail. 2024 Sep;17(9):e011860. doi: 10.1161/CIRCHEARTFAILURE.124.011860. Epub 2024 Aug 28.
BACKGROUND
The PARAGON-HF study (Prospective Comparison of ARNI With ARB Global Outcomes in Heart Failure With Preserved Ejection Fraction) investigated the effect of sacubitril-valsartan in heart failure (HF) with preserved ejection fraction. The results, which were analyzed using conventional statistical methods, did not find a significant reduction in the primary composite end point of cardiovascular death and total hospitalization for HF. Recent clinical trials used win ratio statistics that enable the incorporation of multiple outcome aspects into the primary end point and can detect positive outcomes with fewer patients. In this study, we assessed the effect of sacubitril-valsartan on outcomes using the win ratio to analyze results from patients included in the PARAGON-HF study.
METHODS
In the PARAGON-HF study, 4822 patients with HF with preserved ejection fraction were randomized either to sacubitril-valsartan or valsartan groups. In the present study, the primary outcome was a hierarchical composite of time to cardiovascular death, total number of hospitalization for HF, time to first hospitalization for HF, time to renal composite outcome, and change in the Kansas City Cardiomyopathy Questionnaire total symptom score at 8 months analyzed using a win ratio statistical model.
RESULTS
Using this approach, we found that a greater number of patients who received sacubitril-valsartan experienced clinical benefits compared with those who received valsartan (win ratio, 1.13 [95% CI, 1.04-1.23]; =0.005). This clinical advantage was evident in patients regardless of whether the left ventricular ejection fraction was above or below the median, that is, the left ventricular ejection fraction of 57%, and regardless of sex (=0.76 for the left ventricular ejection fraction and 0.73 for sex).
CONCLUSIONS
Employing the innovative win ratio approach, sacubitril-valsartan demonstrated significant clinical benefits among patients with HF with preserved ejection fraction. Notably, this benefit was observed irrespective of left ventricular ejection fraction and sex.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920711.
背景
PARAGON-HF 研究（心力衰竭伴射血分数保留的 ARNI 与 ARB 全球结果的前瞻性比较）研究了沙库巴曲缬沙坦在射血分数保留的心衰（HF）中的作用。这些结果是使用常规统计方法分析的，并没有发现主要复合终点（心血管死亡和 HF 总住院的综合结果）有显著降低。最近的临床试验使用赢值比统计方法，该方法可以将多个结果方面纳入主要终点，并可以用更少的患者检测到阳性结果。在这项研究中，我们使用赢值比分析方法评估了沙库巴曲缬沙坦对 PARAGON-HF 研究中纳入的患者的治疗效果。
方法
在 PARAGON-HF 研究中，4822 例射血分数保留的心衰患者被随机分为沙库巴曲缬沙坦组或缬沙坦组。本研究的主要终点是使用赢值比统计模型分析 8 个月时心血管死亡时间、HF 总住院次数、首次 HF 住院时间、肾脏复合终点时间以及堪萨斯城心肌病问卷总症状评分变化的分层复合终点。
结果
采用这种方法，我们发现接受沙库巴曲缬沙坦治疗的患者比接受缬沙坦治疗的患者有更多的临床获益（赢值比，1.13[95%置信区间，1.04-1.23]；=0.005）。这种临床优势在左心室射血分数高于或低于中位数（即 57%的左心室射血分数）以及无论性别（左心室射血分数的=0.76 和性别=0.73）的患者中均有显现。
结论
采用创新的赢值比方法，沙库巴曲缬沙坦在心衰伴射血分数保留的患者中显示出显著的临床获益。值得注意的是，这种获益与左心室射血分数和性别无关。
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