Enalapril and Carvedilol for Preventing Chemotherapy-Induced Left Ventricular Systolic Dysfunction in Patients With Malignant Hemopathies: The OVERCOME Trial (preventiOn of left Ventricular dysfunction with Enalapril and caRvedilol in patients submitted to intensive ChemOtherapy for the treatment of Malignant hEmopathies)

This study sought to evaluate the efficacy of enalapril and carvedilol to prevent chemotherapy-induced left ventricular systolic dysfunction (LVSD) in patients with hematological malignancies. Current chemotherapy may induce LVSD. Angiotensin-converting enzyme inhibitors and beta-blockers prevent LV...

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Bibliographic Details
Published in:Journal of the American College of Cardiology 2013-06, Vol.61 (23), p.2355-2362
Main Authors: BOSCH, Xavier, ROVIRA, Montserrat, SITGES, Marta, DOMENECH, Ariadna, ORTIZ-PEREZ, José T, DE CARALT, Teresa M, MORALES-RUIZ, Manuel, PEREA, Rosario J, MONZO, Mariano, ESTEVE, Jordi
Format: Article
Language:English
Subjects:
Adult
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Biological and medical sciences
Carbazoles - administration & dosage
Cardiology. Vascular system
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
Echocardiography, Doppler
Enalapril - administration & dosage
Female
Follow-Up Studies
Heart
Heart failure, cardiogenic pulmonary edema, cardiac enlargement
Hematologic Neoplasms - drug therapy
Hematologic Neoplasms - pathology
Humans
Male
Medical sciences
Middle Aged
Propanolamines - administration & dosage
Reference Values
Risk Assessment
Severity of Illness Index
Survival Rate
Treatment Outcome
Ventricular Dysfunction, Left - chemically induced
Ventricular Dysfunction, Left - drug therapy
Ventricular Dysfunction, Left - prevention & control
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Summary:This study sought to evaluate the efficacy of enalapril and carvedilol to prevent chemotherapy-induced left ventricular systolic dysfunction (LVSD) in patients with hematological malignancies. Current chemotherapy may induce LVSD. Angiotensin-converting enzyme inhibitors and beta-blockers prevent LVSD in animal models of anthracycline-induced cardiomyopathy. In this randomized, controlled study, 90 patients with recently diagnosed acute leukemia (n = 36) or patients with malignant hemopathies undergoing autologous hematopoietic stem cell transplantation (HSCT) (n = 54) and without LVSD were randomly assigned to a group receiving enalapril and carvedilol (n = 45) or to a control group (n = 45). Echocardiographic and cardiac magnetic resonance (CMR) imaging studies were performed before and at 6 months after randomization. The primary efficacy endpoint was the absolute change from baseline in LV ejection fraction (LVEF). The mean age of patients was 50 ± 13 years old, and 43% were women. At 6 months, LVEF did not change in the intervention group but significantly decreased in controls, resulting in a -3.1% absolute difference by echocardiography (p = 0.035) and -3.4% (p = 0.09) in the 59 patients who underwent CMR. The corresponding absolute difference (95% confidence interval [CI]) in LVEF was -6.38% (95% CI: -11.9 to -0.9) in patients with acute leukemia and -1.0% (95% CI: -4.5 to 2.5) in patients undergoing autologous HSCT (p = 0.08 for interaction between treatment effect and disease category). Compared to controls, patients in the intervention group had a lower incidence of the combined event of death or heart failure (6.7% vs. 22%, p = 0.036) and of death, heart failure, or a final LVEF
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2013.02.072