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

Abstract

IntroductionTranscatheter 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 analysisThe 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 disseminationAll 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 numberNCT03201185.

Neutrophil‐to‐Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries

“… 19 Emerging data suggest a potential benefit of renin‐angiotensin system inhibition after TAVR on left ventricular remodeling, 20 , 21 and this hypothesis is being tested in the ongoing RASTAVI (Renin‐Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation) trial. 22 Whether aggressive medical therapy such as renin‐angiotensin system inhibition after AVR would benefit those with residual HF and the extent to which improvements in HF symptoms would be accompanied by reduced systemic inflammation in these patients should be studied. Furthermore, reducing procedural complications such as moderate/severe paravalvular leak that is associated with more residual HF 23 might also have an impact on systemic inflammation.…”

The clinical outcomes of reni-angiotensin system inhibitors for patients after transcatheter aortic valve replacement: A systematic review and meta-analysis

“…The potential confounders and bias may exist in included retrospective studies. Some ongoing RCTs including the RASTAVI trial (NCT03201185) and other trials (ChiCTR2100042266, ChiCTR 2100042266) will give us new evidence for this issue ( 37 , 38 ).…”

Impact of renin–angiotensin system inhibitors on outcomes after transcatheter aortic valve replacement: A meta‐analysis

“…Therefore, the application of RAS inhibitors in patients undergoing TAVR merits further investigation. An ongoing randomized controlled trial, RASTAVI (NCT03201185), 26 will add new evidence to this issue.…”