Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial

Bibliographic Details
Title: Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial
Authors: Ignacio J. Amat‐Santos, Diego López‐Otero, Luis Nombela‐Franco, Vicente Peral‐Disdier, Enrique Gutiérrez‐Ibañes, Victor Jiménez‐Diaz, Antonio Muñoz‐Garcia, Raquel Del Valle, Ander Regueiro, Borja Ibáñez, Rafael Romaguera, Carlos Cuellas Ramón, Bruno García, Pedro L. Sánchez, Javier Gómez‐Herrero, Jose R. Gonzalez‐Juanatey, Gabriela Tirado‐Conte, Francisco Fernández‐Avilés, Sergio Raposeiras, Ana Revilla‐Orodea, Javier López‐Diaz, Itziar Gómez, Manuel Carrasco‐Moraleja, J. A. San Román
Source: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 13, Iss 19 (2024)
Publisher Information: Wiley, 2024.
Publication Year: 2024
Collection: LCC:Diseases of the circulatory (Cardiovascular) system
Subject Terms: renin‐angiotensin, TAVR, ventricular remodeling, Diseases of the circulatory (Cardiovascular) system, RC666-701
More Details: Background Patients with aortic stenosis may continue to have an increased risk of heart failure, arrhythmias, and death after successful transcatheter aortic valve implantation. Renin‐angiotensin system inhibitors may be beneficial in this setting. We aimed to explore whether ramipril improves the outcomes of patients with aortic stenosis after transcatheter aortic valve implantation. Methods and Results PROBE (Prospective Randomized Open, Blinded Endpoint) was a multicenter trial comparing ramipril with standard care (control) following successful transcatheter aortic valve implantation in patients with left ventricular ejection fraction >40%. The primary end point was the composite of cardiac mortality, heart failure readmission, and stroke at 1‐year follow‐up. Secondary end points included left ventricular remodeling and fibrosis. A total of 186 patients with median age 83 years (range 79–86), 58.1% women, and EuroSCORE‐II 3.75% (range 3.08–4.97) were randomized to receive either ramipril (n=94) or standard treatment (n=92). There were no significant baseline, procedural, or in‐hospital differences. The primary end point occurred in 10.6% in the ramipril group versus 12% in the control group (P=0.776), with no differences in cardiac mortality (ramipril 1.1% versus control group 2.2%, P=0.619) but lower rate of heart failure readmissions in the ramipril group (3.2% versus 10.9%, P=0.040). Cardiac magnetic resonance analysis demonstrated better remodeling in the ramipril compared with the control group, with greater reduction in end‐systolic and end‐diastolic left ventricular volumes, but nonsignificant differences were found in the percentage of myocardial fibrosis. Conclusions Ramipril administration after transcatheter aortic valve implantation in patients with preserved left ventricular function did not meet the primary end point but was associated with a reduction in heart failure re‐admissions at 1‐year follow‐up. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03201185.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2047-9980
Relation: https://doaj.org/toc/2047-9980
DOI: 10.1161/JAHA.124.035460
Access URL: https://doaj.org/article/caae53a55b5b4610ad3a59448d2f72a6
Accession Number: edsdoj.53a55b5b4610ad3a59448d2f72a6
Database: Directory of Open Access Journals
More Details
ISSN:20479980
DOI:10.1161/JAHA.124.035460
Published in:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Language:English