AI Article Synopsis
- The PARAGON-HF study compared the effects of sacubitril-valsartan and valsartan on heart failure with preserved ejection fraction but initially found no significant benefits using traditional statistical methods.
- This new analysis applied a win ratio statistical model to reevaluate the outcomes from the PARAGON-HF study, focusing on various clinical measures, including hospitalizations and symptom scores.
- The results indicated that patients receiving sacubitril-valsartan experienced more clinical benefits than those on valsartan, regardless of their ejection fraction or sex, showing a significant advantage for the treatment.
Article Abstract
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.
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| http://dx.doi.org/10.1161/CIRCHEARTFAILURE.124.011860 | DOI Listing |
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