scholarly journals 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

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e020255 ◽  
Author(s):  
Ignacio J Amat-Santos ◽  
Pablo Catalá ◽  
Felipe Diez del Hoyo ◽  
Jose A Fernandez-Diaz ◽  
Juan H Alonso-Briales ◽  
...  

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.

Heart ◽  
2017 ◽  
Vol 104 (8) ◽  
pp. 644-651 ◽  
Author(s):  
Tomoki Ochiai ◽  
Shigeru Saito ◽  
Futoshi Yamanaka ◽  
Koki Shishido ◽  
Yutaka Tanaka ◽  
...  

ObjectiveThe persistence of left ventricular (LV) hypertrophy is associated with poor clinical outcomes after transcatheter aortic valve implantation (TAVI) for aortic stenosis. However, the optimal medical therapy after TAVI remains unknown. We investigated the effect of renin−angiotensin system (RAS) blockade therapy on LV hypertrophy and mortality in patients undergoing TAVI.MethodsBetween October 2013 and April 2016, 1215 patients undergoing TAVI were prospectively enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry. This cohort was stratified according to the postoperative usage of RAS blockade therapy with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs). Patients with at least two prescriptions dispensed 180 days apart after TAVI and at least a 6-month follow-up constituted the RAS blockade group (n=371), while those not prescribed any ACE inhibitors or ARBs after TAVI were included in the no RAS blockade group (n=189).ResultsAt 6 months postoperatively, the RAS blockade group had significantly greater LV mass index regression than the no RAS blockade group (−9±24% vs −2±25%, p=0.024). Kaplan-Meier analysis revealed a significantly lower cumulative 2-year mortality in the RAS blockade than that in the no RAS blockade group (7.5% vs 12.5%; log-rank test, p=0.031). After adjusting for confounding factors, RAS blockade therapy was associated with significantly lower all-cause mortality (HR, 0.45; 95% CI 0.22 to 0.91; p=0.025).ConclusionsPostoperative RAS blockade therapy is associated with greater LV mass index regression and reduced all-cause mortality. These data need to be confirmed by a prospective randomised controlled outcome trial.


Heart ◽  
2018 ◽  
Vol 104 (24) ◽  
pp. 2058-2066 ◽  
Author(s):  
Rodrigo Bagur ◽  
Glen Philip Martin ◽  
Luis Nombela-Franco ◽  
Sagar N Doshi ◽  
Sudhakar George ◽  
...  

ObjectivesTo investigate the association of the CharlsonComorbidity Index (CCI) with clinical outcomes after transcatheter aortic valve implantation (TAVI).BackgroundPatients undergoing TAVI have high comorbid burden; however, there is limited evidence of its impact on clinical outcomes.MethodsData from 1887 patients from the UK, Canada, Spain, Switzerland and Italy were collected between 2007 and 2016. The association of CCI with 30-day mortality, Valve Academic Research Consortium-2 (VARC-2) composite early safety, long-term survival and length of stay (LoS) was calculated using logistic regression and Cox proportional hazard models, as a whole cohort and at a country level, through a two-stage individual participant data (IPD) random effect meta-analysis.ResultsMost (60%) of patients had a CCI ≥3. A weak correlation was found between the total CCI and four different preoperative risks scores (ρ=0.16 to 0.29), and approximately 50% of patients classed as low risk from four risk prediction models still presented with a CCI ≥3. Per-unit increases in total CCI were not associated with increased odds of 30-day mortality (OR 1.09, 95% CI 0.96 to 1.24) or VARC-2 early safety (OR 1.04, 95% CI 0.96 to 1.14) but were associated with increased hazard of long-term mortality (HR 1.10, 95% CI 1.05 to 1.16). The two-stage IPD meta-analysis indicated that CCI was not associated with LoS (HR 0.97, 95% CI 0.93 to 1.02).ConclusionIn this multicentre international study, patients undergoing TAVI had significant comorbid burden. We found a weak correlation between the CCI and well-established preoperative risks scores. The CCI had a moderate association with long-term mortality up to 5 years post-TAVI.


2013 ◽  
Vol 62 (18) ◽  
pp. B236
Author(s):  
Gabriela Campos Cardoso de Lima ◽  
Dimytri A. Siqueira ◽  
Luiz Antonio Carvalho ◽  
Rogério Rogério Sarmento-Leite ◽  
Jose A. Mangione ◽  
...  

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