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

Marianna Adamo; Marco Metra; Brian L Claggett; Zi Michael Miao; Rafael Diaz; G Michael Felker; John J V McMurray; Scott D Solomon; Tor Biering-Sørensen; Punag H Divanji; Stephen B Heitner; Stuart Kupfer; Fady I Malik; John R Teerlink; GALACTIC-HF Investigators and Patients

doi:10.1016/j.jchf.2023.11.018

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

Marianna Adamo, Marco Metra, Brian L Claggett, Zi Michael Miao, Rafael Diaz, G Michael Felker, John J V McMurray, Scott D Solomon, Tor Biering-Sørensen, Punag H Divanji, Stephen B Heitner, Stuart Kupfer, Fady I Malik, John R Teerlink, GALACTIC-HF Investigators and Patients

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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.

Originalsprog	Engelsk
Tidsskrift	JACC. Heart failure
Vol/bind	12
Udgave nummer	3
Sider (fra-til)	552-563
Antal sider	12
ISSN	2213-1779
DOI	https://doi.org/10.1016/j.jchf.2023.11.018
Status	Udgivet - mar. 2024

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10.1016/j.jchf.2023.11.018

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Adamo, M., Metra, M., Claggett, B. L., Miao, Z. M., Diaz, R., Felker, G. M., McMurray, J. J. V., Solomon, S. D., Biering-Sørensen, T., Divanji, P. H., Heitner, S. B., Kupfer, S., Malik, F. I., Teerlink, J. R., & GALACTIC-HF Investigators and Patients (2024). Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction. JACC. Heart failure, 12(3), 552-563. https://doi.org/10.1016/j.jchf.2023.11.018

Adamo, M, Metra, M, Claggett, BL, Miao, ZM, Diaz, R, Felker, GM, McMurray, JJV, Solomon, SD, Biering-Sørensen, T, Divanji, PH, Heitner, SB, Kupfer, S, Malik, FI, Teerlink, JR & GALACTIC-HF Investigators and Patients 2024, 'Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction', JACC. Heart failure, bind 12, nr. 3, s. 552-563. https://doi.org/10.1016/j.jchf.2023.11.018

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title = "Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction",

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 = "Humans, Heart Failure/complications, Stroke Volume, Tricuspid Valve Insufficiency/complications, Ventricular Function, Left, Ventricular Dysfunction, Left, Urea/analogs & derivatives",

author = "Marianna Adamo and Marco Metra and Claggett, {Brian L} and Miao, {Zi Michael} and Rafael Diaz and Felker, {G Michael} and McMurray, {John J V} and Solomon, {Scott D} and Tor Biering-S{\o}rensen and Divanji, {Punag H} and Heitner, {Stephen B} and Stuart Kupfer and Malik, {Fady I} and Teerlink, {John R} and {GALACTIC-HF Investigators and Patients}",

year = "2024",

month = mar,

doi = "10.1016/j.jchf.2023.11.018",

language = "English",

volume = "12",

pages = "552--563",

journal = "JACC. Heart failure",

issn = "2213-1779",

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T1 - Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction

AU - Adamo, Marianna

AU - Metra, Marco

AU - Claggett, Brian L

AU - Miao, Zi Michael

AU - Diaz, Rafael

AU - Felker, G Michael

AU - McMurray, John J V

AU - Solomon, Scott D

AU - Biering-Sørensen, Tor

AU - Divanji, Punag H

AU - Heitner, Stephen B

AU - Kupfer, Stuart

AU - Malik, Fady I

AU - Teerlink, John R

AU - GALACTIC-HF Investigators and Patients

PY - 2024/3

Y1 - 2024/3

N2 - 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.

AB - 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.

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KW - Heart Failure/complications

KW - Stroke Volume

KW - Tricuspid Valve Insufficiency/complications

KW - Ventricular Function, Left

KW - Ventricular Dysfunction, Left

KW - Urea/analogs & derivatives

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U2 - 10.1016/j.jchf.2023.11.018

DO - 10.1016/j.jchf.2023.11.018

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SN - 2213-1779

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JO - JACC. Heart failure

JF - JACC. Heart failure

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ER -

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

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