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Randomized Controlled Trial
. 2024 Mar;12(3):552-563.
doi: 10.1016/j.jchf.2023.11.018. Epub 2024 Jan 31.

Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction

Marianna Adamo  1 , Marco Metra  2 , Brian L Claggett  3 , Zi Michael Miao  3 , Rafael Diaz  4 , G Michael Felker  5 , John J V McMurray  6 , Scott D Solomon  3 , Tor Biering-Sørensen  7 , Punag H Divanji  8 , Stephen B Heitner  8 , Stuart Kupfer  8 , Fady I Malik  8 , John R Teerlink  9 ; GALACTIC-HF Investigators and Patients
Affiliations
Free article
Randomized Controlled Trial

Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction

Marianna Adamo et al. JACC Heart Fail. 2024 Mar.
Free article

Abstract

Background: Tricuspid regurgitation (TR) is common and is associated with poor outcomes in patients with heart failure (HF). However, data with adjudicated events from fully characterized patients with heart failure with reduced ejection fraction (HFrEF) are lacking.

Objectives: This study sought to explore the association between mild or moderate/severe TR and clinical outcomes of patients with HFrEF.

Methods: GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) was a double-blind, placebo-controlled randomized trial comparing omecamtiv mecarbil vs placebo in patients with symptomatic HFrEF.

Results: Among the 8,232 patients analyzed in the GALACTIC-HF trial, 8,180 (99%) had data regarding baseline TR (none: n = 6,476 [79%], mild: n = 919 [11%], and moderate/severe: n = 785 [10%]). The primary composite outcome of a first HF event or cardiovascular death occurred in 2,368 (36.6%) patients with no TR, 353 (38.4%) patients with mild TR, and 389 (49.6%) patients with moderate/severe TR. Moderate/severe TR was independently associated with a higher relative risk of the primary composite outcome compared with either no TR (adjusted HR: 1.12 [95% CI: 1.01-1.26]; P = 0.046) or no/mild TR (adjusted HR: 1.14 [95% CI: 1.02-1.27]; P = 0.025) driven predominantly by HF events. The association between moderate/severe TR and clinical outcomes was more pronounced in outpatients with worse renal function, higher left ventricular ejection fraction, and lower N-terminal pro-B-type natriuretic peptide and bilirubin levels. The beneficial treatment effect of omecamtiv mecarbil vs placebo on clinical outcomes was not modified by TR.

Conclusions: In symptomatic patients with HFrEF, baseline moderate/severe TR was independently associated with cardiovascular death or HF events driven predominantly by HF events. The beneficial treatment effect of omecamtiv mecarbil on the primary outcome was not modified by TR.

Keywords: heart failure; outcomes; tricuspid regurgitation.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Adamo has received specker honoraria from Abbott Vascular. Dr Metra has received consulting fees from Abbott Vascular, Actelion, Amgen, AstraZeneca, Bayer, Edwards Therapeutics, Livanova, Servier, Vifor Pharma, and WindTree Therapeutics. Dr Claggett has received consulting fees from Amgen and Myokardia. Dr Diaz has received research grants and/or consulting fees from Amgen, Cytokinetics, and Servier. Dr Felker has received grant funding to his institution from Amgen, Bayer, Cytokinetics, Merck, and Myokardia; has received consulting fees personally from Abbott, American Regent, Amgen, AstraZeneca, Becton Dickinson, Boehringer Ingelheim, Bristol Myers Squibb, Cardionomic, Cytokinetics, Medtronic, Novartis, and Sequana; and has served on the Board of Directors for the Heart Failure Society of America. Dr McMurray has received consulting fees paid to his institution from Alnylam, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardialysis, Cardurion, Dal-Cor, GlaxoSmithKline, Ionis, KBP Biosciences, Merck, Novartis, Pfizer, and Theracos. Dr Solomon has received grants from Celladon, Eidos, Ionis, Lone Star Heart, Mesoblast, National Institutes of Health/National Heart, Lung, and Blood Institute, and Sanofi Pasteur; has received grants and personal fees from Alnylam, Amgen, AstraZeneca, Bayer, Bellerophon, Bristol Myers Squibb, Cytokinetics, Gilead, GlaxoSmithKline, MyoKardia, Novartis, and Theracos; and has received personal fees from Akros, AoBiome, Arena, Cardiac Dimensions, Cardior, Cardurion, Corvia, Daiichi-Sankyo, Dinaqor, Ironwood, Janssen, Merck, Moderna, Quantum Genomics, Roche, Takeda, and Tenaya. Dr Teerlink has received research grants and/or consulting fees from Abbott Laboratories, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Medtronic, Merck, Novartis, Servier, and Windtree Therapeutics; has received support for attending meetings and/or travel from Abbott Laboratories, Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, EBR Systems, LivaNova, Medtronic, Servier, and WindTree Therapeutics; and has served as Treasurer to Heart Failure Society of America. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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