Circ Heart Fail. 2024;17(9):e011860.
Analysis of the PARAGON-HF Study Results Using Win Ratio.
제1저자 윤민재, 김원세 · 교신저자 박진주, 국웅
소속 (4)
- 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).
- MetaEyes, Seoul, Republic of Korea (W. Kim).
- Cardiology Department, University of California San Diego, La Jolla (B.G.).
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]; P=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 (Pinteraction=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.
Keywords
heart failuresacubitril and valsartan sodium hydrate drug combinationtherapeuticstreatment outcomes
Comment · 정정
Conflict of interest statement
None.
그 밖의 정보
- 출판 형태
- Journal Article, Randomized Controlled Trial, Multicenter Study
- 저널
- Circulation. Heart failure · eISSN 1941-3297
- 전자 출판
- 2024-08-28
- MeSH
- Humans · Valsartan* / therapeutic use · Heart Failure* / drug therapy / physiopathology / mortality · Aminobutyrates* / therapeutic use · Male · Female · Biphenyl Compounds* / therapeutic use · Aged · Stroke Volume* / physiology · Drug Combinations* · Middle Aged · Angiotensin Receptor Antagonists* / therapeutic use · Treatment Outcome · Prospective Studies · Tetrazoles / therapeutic use · Hospitalization / statistics & numerical data · Ventricular Function, Left / drug effects / physiology · Time Factors
- Substances
- Valsartan · Aminobutyrates · sacubitril and valsartan sodium hydrate drug combination · Biphenyl Compounds · Drug Combinations · Angiotensin Receptor Antagonists · Tetrazoles
- 데이터
- ClinicalTrials.gov: NCT01920711