Academic Journal

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

التفاصيل البيبلوغرافية
العنوان: Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial
المؤلفون: Amat‐Santos, Ignacio J., López‐Otero, Diego, Nombela‐Franco, Luis, Peral‐Disdier, Vicente, Gutiérrez‐Ibañes, Enrique, Jiménez‐Diaz, Victor, Muñoz‐Garcia, Antonio, Del Valle, Raquel, Regueiro, Ander, Ibáñez, Borja, Romaguera, Rafael, Cuellas Ramón, Carlos, García, Bruno, Sánchez, Pedro L., Gómez‐Herrero, Javier, Gonzalez‐Juanatey, Jose R., Tirado‐Conte, Gabriela, Fernández‐Avilés, Francisco, Raposeiras, Sergio, Revilla‐Orodea, Ana, López‐Diaz, Javier, Gómez, Itziar, Carrasco‐Moraleja, Manuel, San Román, J. A.
المصدر: Journal of the American Heart Association ; volume 13, issue 19 ; ISSN 2047-9980
بيانات النشر: Ovid Technologies (Wolters Kluwer Health)
سنة النشر: 2024
الوصف: 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.
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1161/jaha.124.035460
DOI: 10.1161/JAHA.124.035460
الاتاحة: http://dx.doi.org/10.1161/jaha.124.035460
https://www.ahajournals.org/doi/full/10.1161/JAHA.124.035460
رقم الانضمام: edsbas.129CA148
قاعدة البيانات: BASE