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Analysis of the PARAGON-HF Study Results Using Win Ratio
Minjae Yoon1, Wonse Kim2,3, Woong Kook2
1Cardiovascular 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.).
Circulation. Heart Failure
|August 28, 2024
Summary
The win ratio analysis of the PARAGON-HF trial revealed that sacubitril-valsartan offers significant clinical benefits for patients with heart failure with preserved ejection fraction, irrespective of sex or ejection fraction levels.
Area of Science:
- Cardiology
- Clinical Trials
- Heart Failure Research
Background:
- The PARAGON-HF trial initially showed no significant reduction in cardiovascular death or HF hospitalizations with sacubitril-valsartan versus valsartan using conventional statistics.
- Win ratio statistics offer a novel approach to analyze clinical trial data by incorporating multiple outcome aspects into a single endpoint.
Purpose of the Study:
- To re-evaluate the PARAGON-HF trial data using win ratio statistics to assess the clinical benefits of sacubitril-valsartan in heart failure with preserved ejection fraction (HFpEF).
Main Methods:
- The study analyzed data from 4822 patients with HFpEF randomized in the PARAGON-HF trial.
- A win ratio statistical model was applied to a hierarchical composite outcome including cardiovascular death, HF hospitalizations, renal outcomes, and symptom scores.
Main Results:
- Sacubitril-valsartan demonstrated a statistically significant clinical benefit compared to valsartan (win ratio: 1.13; P=0.005).
- This benefit was consistent across subgroups, including patients with left ventricular ejection fraction above or below the median (57%) and across sexes.
Conclusions:
- The win ratio approach reveals significant clinical advantages of sacubitril-valsartan in patients with HFpEF.
- These benefits are evident regardless of the patient's left ventricular ejection fraction or sex, highlighting the drug's broad applicability.
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