Post-TAVR AICS are uncommon but have high 30-day mortality if left untreated, especially in symptomatic patients. Percutaneous closure was feasible and safe in symptomatic patients but remains controversial in asymptomatic subjects.
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.
Background: Recently, the use of transcatheter aortic valve implantation (TAVI) in intermediate-low risk patients has been evaluated in the PARTNER
± 9 days after SAVR (p = 0.003). After matched comparison, no differences in terms of in-hospital mortality (5.7% after TAVI vs. 2.9% after SAVR, p = 0.687) and 1-year mortality (11.4% vs. 7.1%, p = 0.381) were found. The combined endpoint of stroke and mortality at 1-year was also similar between both groups (15.7% in TAVI patients vs. 14.4% after SAVR, p = 0.136). Multivariate analysis determined that aortic regurgitation (AR) was an independent predictor of mortality (OR = 3.623, p = 0.016 (Cardiol J 2016; 23, 5: 541-551)
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