Covariate adjusted reanalysis of the I-Preserve trial

Autor: João Pedro Ferreira, Pardeep S. Jhund, Michael R. Zile, Faiez Zannad, Peter E. Carson, Kevin Duarte, Pooja Dewan, John J.V. McMurray, Ana Lorenzo-Almorós, Michel Komajda, Mark C. Petrie, Robert S. McKelvie
Přispěvatelé: Centre d'investigation clinique plurithématique Pierre Drouin [Nancy] (CIC-P), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (INI-CRCT), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Cardiovascular & Renal Clinical Trialists - CRCT ), BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Department of Internal Medicine. Renal, Vascular and Diabetes Laboratory, Instituto de Investigaciones Sanitarias Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Cardiovascular Division, Department of Cardiology, Washington Veterans Affairs Medical Center, Washington, DC, Department of Medicine, Western University, London, ON, Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, South Carolina, JPF is supported by the French National Research Agency Fighting Heart Failure (ANR-15-RHU-0004), by the French PIA project 'Lorraine Université d’Excellence' GEENAGE (ANR-15-IDEX-04-LUE) programmes, and the Contrat de Plan Etat Région Lorraine and FEDER IT2MP, ANR-15-RHUS-0004,FIGHT-HF,Combattre l'insuffisance cardiaque(2015), ANR-15-IDEX-0004,LUE,Isite LUE(2015), BOZEC, Erwan, Combattre l'insuffisance cardiaque - - FIGHT-HF2015 - ANR-15-RHUS-0004 - RHUS - VALID, ISITE - Isite LUE - - LUE2015 - ANR-15-IDEX-0004 - IDEX - VALID
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
medicine.medical_specialty
030204 cardiovascular system & hematology
Treatment effects
Angiotensin Receptor Antagonists
03 medical and health sciences
0302 clinical medicine
[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system
Statistical significance
Internal medicine
medicine
Humans
030212 general & internal medicine
Myocardial infarction
Aged
Heart Failure
Covariate adjustment
Unstable angina
business.industry
Proportional hazards model
Hazard ratio
Stroke Volume
Irbesartan
General Medicine
Middle Aged
Prognosis
medicine.disease
Confidence interval
[SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system
Hospitalization
Heart failure with preserved ejection fraction
Heart failure
Cardiology
Female
Cardiology and Cardiovascular Medicine
business
Angiotensin II Type 1 Receptor Blockers
Zdroj: Clinical Research in Cardiology
Clinical Research in Cardiology, Springer Verlag, 2020, 109 (11), pp.1358-1365. ⟨10.1007/s00392-020-01632-x⟩
ISSN: 1861-0684
1861-0692
DOI: 10.1007/s00392-020-01632-x⟩
Popis: Background:\ud \ud The CHARM-Preserved trial suggested that the renin-angiotensin system (RAS) inhibitor candesartan might have been beneficial in heart failure with preserved ejection fraction (HFpEF); however, this hypothesis was not supported by the findings of I-Preserve with irbesartan.\ud \ud Aims:\ud \ud To re-analyse the results of I-Preserve, adjusting for imbalances in baseline variables that may have influenced the trial outcomes.\ud \ud Methods:\ud \ud Cox proportional hazards models with covariate adjustment for baseline variables, including age, sex, medical history, physiological and laboratory variables.\ud \ud Results:\ud \ud In I-Preserve, 763 (37.0%) participants in the placebo group and 742 (35.9%) in the irbesartan group experienced the primary composite outcome (death from any cause or hospitalization for heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). The prespecified analysis of this outcome, stratifying for the use of ACEi at baseline, gave a hazard ratio (HR) of 0.95 (95% confidence interval, 0.86–1.05); p = 0.35. Adjusting the effect of treatment for key prognostic baseline variables, gave a HR of 0.89 (0.80–0.99); p = 0.033. Similar findings were observed for the composite of cardiovascular death or HF hospitalization.\ud \ud Conclusion:\ud \ud Adjusting for imbalances in baseline variables that influence outcomes (or the response to therapy or both) can improve the power around the estimate of the effect of treatment and may alter its statistical significance. Along with the CHARM-Preserved results, these findings suggest that angiotensin-receptor blockers may have a modest effect in HFpEF.
Databáze: OpenAIRE
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