Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study

Ignacio J Amat-Santos, Pablo Catalá, Felipe Diez Del Hoyo, Jose A Fernandez-Diaz, Juan H Alonso-Briales, María Del Trigo, Ander Regueiro, Pablo Juan-Salvadores, Vicenç Serra, Enrique Gutierrez-Ibanes, Antonio J Muñoz-García, Luis Nombela-Franco, Manel Sabate, Victor A Jimenez-Diaz, Bruno García Del Blanco, Javier López, Luis H Varela-Falcón, Teresa Sevilla, Roman Arnold, Ana Revilla, J Alberto San Roman, Ignacio J Amat-Santos, Pablo Catalá, Felipe Diez Del Hoyo, Jose A Fernandez-Diaz, Juan H Alonso-Briales, María Del Trigo, Ander Regueiro, Pablo Juan-Salvadores, Vicenç Serra, Enrique Gutierrez-Ibanes, Antonio J Muñoz-García, Luis Nombela-Franco, Manel Sabate, Victor A Jimenez-Diaz, Bruno García Del Blanco, Javier López, Luis H Varela-Falcón, Teresa Sevilla, Roman Arnold, Ana Revilla, J Alberto San Roman

Abstract

Introduction: Transcatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement.

Methods and analysis: The RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure. The study has been designed as a randomised 1:1 open-label study that will be undertaken in 8 centres including 336 TAVI recipients. All patients will receive the standard treatment. The active treatment group will receive ramipril as well. Randomisation will be done before discharge, after signing informed consent. All patients will be followed up for 3 years. A cardiac magnetic resonance will be performed initially and at 1 year to assess ventricular remodelling, defined as ventricular dimensions, ejection fraction, ventricular mass and fibrosis. Recorded events will include cardiac death, admission due to heart failure and stroke. The RASTAVI Study will improve the management of patients after TAVI and may help to increase their quality of life, reduce readmissions and improve long-term survival in this scenario.

Ethics and dissemination: All authors and local ethics committees have approved the study design. All patients will provide informed consent. Results will be published irrespective of whether the findings are positive or negative.

Trial registration number: NCT03201185.

Keywords: adult cardiology; echocardiography; heart failure; valvular heart disease.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Schematic workflow for the RAS blockade after TAVI (RASTAVI) Study. 6-MWT: 6-min walk test; CMR, cardiac magnetic resonance; FU, follow-up; RAS, renin-angiotensin system; TAVI, transcatheter aortic valve implantation; TTE, transthoracic echocardiography. Note: telephonic 36-month follow-up visit is allowed.

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Source: PubMed

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