Sacubitril/valsartan versus ramipril for patients with acute myocardial infarction: win-ratio analysis of the PARADISE-MI trial.
Humans
Ramipril
/ therapeutic use
Stroke Volume
Angiotensin Receptor Antagonists
Neprilysin
Tetrazoles
/ therapeutic use
Heart Failure
Ventricular Function, Left
Aminobutyrates
/ therapeutic use
Valsartan
/ therapeutic use
Biphenyl Compounds
/ therapeutic use
Drug Combinations
Myocardial Infarction
/ drug therapy
Acute myocardial infarction
Angiotensin receptor-neprilysin inhibition
Sacubitril/valsartan
Win ratio
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
revised:
20
08
2022
received:
09
08
2022
accepted:
22
08
2022
pubmed:
3
9
2022
medline:
29
11
2022
entrez:
2
9
2022
Statut:
ppublish
Résumé
The win ratio can incorporate different types of outcomes and enhance statistical power, making it a useful method for analysing composite outcomes in cardiovascular trials. The application of this approach to the PARADISE-MI trial provides an additional perspective into understanding the effects of sacubitril/valsartan in patients with acute myocardial infarction. We conducted a post-hoc analysis of the PARADISE-MI trial, which randomly assigned patients with acute myocardial infarction complicated by a reduced left ventricular ejection fraction, pulmonary congestion, or both to receive either sacubitril/valsartan (97 mg of sacubitril and 103 mg of valsartan twice daily) or ramipril (5 mg twice daily) in addition to guideline-recommended therapy. The principal composite outcome was analysed in the hierarchical order of death due to cardiovascular causes, first hospitalization for heart failure, and first outpatient episode of symptomatic heart failure. We included events confirmed by the clinical events classification (CEC) committee as well as events identified by investigators that did not meet study definitions. Results were analysed by the unmatched win-ratio method. A win ratio that exceeds 1.00 reflects a better outcome. A total of 5661 patients underwent randomization; 2830 were assigned to receive sacubitril/valsartan and 2831 to receive ramipril. The hierarchical analysis of the principal composite outcome demonstrated a larger number of wins (1 265 767 [15.7%]) than losses (1 079 502 [13.4%]) in the sacubitril/valsartan group (win ratio of 1.17, 95% confidence interval [CI] 1.03-1.33; p = 0.015). Sensitivity analyses using alternative definitions of the composite outcome showed results similar to those of the principal analysis, except for analysis restricted to events that met CEC definitions (win ratio of 1.11, 95% CI 0.96-1.30; p = 0.16). In this post-hoc analysis of the PARADISE-MI trial using the win ratio and including investigator-identified events not having CEC confirmation, sacubitril/valsartan was superior to ramipril among high-risk survivors of acute myocardial infarction.
Substances chimiques
sacubitril
17ERJ0MKGI
Ramipril
L35JN3I7SJ
Angiotensin Receptor Antagonists
0
Neprilysin
EC 3.4.24.11
Tetrazoles
0
Aminobutyrates
0
Valsartan
80M03YXJ7I
Biphenyl Compounds
0
Drug Combinations
0
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1918-1927Informations de copyright
© 2022 European Society of Cardiology.
Références
Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003;289:2554-9.
Lubsen J, Kirwan BA. Combined endpoints: can we use them? Stat Med. 2002;21:2959-70.
Montori VM, Permanyer-Miralda G, Ferreira-Gonzalez I, Busse JW, Pacheco-Huergo V, Bryant D, et al. Validity of composite end points in clinical trials. BMJ. 2005;330:594-6.
Austin PC, Lee DS, Fine JP. Introduction to the analysis of survival data in the presence of competing risks. Circulation. 2016;133:601-9.
Ferreira-Gonzalez I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ. 2007;334:786.
Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012;33:176-82.
Redfors B, Gregson J, Crowley A, McAndrew T, Ben-Yehuda O, Stone GW, et al. The win ratio approach for composite endpoints: practical guidance based on previous experience. Eur Heart J. 2020;41:4391-9.
Jering KS, Claggett B, Pfeffer MA, Granger C, Køber L, Lewis EF, et al. Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI): design and baseline characteristics. Eur J Heart Fail. 2021;23:1040-8.
Pfeffer MA, Claggett B, Lewis EF, Granger CB, Køber L, Maggioni AP, et al.; PARADISE-MI Investigators and Committees. Angiotensin receptor-neprilysin inhibition in acute myocardial infarction. N Engl J Med. 2021;385:1845-55.
Pfeffer MA, Claggett B, Lewis EF, Granger CB, Køber L, Maggioni AP, et al. Impact of sacubitril/valsartan versus ramipril on total heart failure events in the PARADISE-MI trial. Circulation. 2022;145:87-9.
Pocock SJ, Stone GW. The primary outcome fails - what next? N Engl J Med. 2016;375:861-70.
Oakes D. On the win-ratio statistic in clinical trials with multiple types of event. Biometrika. 2016;103:742-5.
Ferreira JP, Jhund PS, Duarte K, Claggett BL, Solomon SD, Pocock S, et al. Use of the win ratio in cardiovascular trials. JACC Heart Fail. 2020;8:441-50.
The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997;336:525-33.
McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al.; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004.
Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, et al.; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003;348:1309-21.
Dong G, Qiu J, Wang D, Vandemeulebroecke M. The stratified win ratio. J Biopharm Stat. 2018;28:778-96.