RASTAVI
Trial question
What is the role of ramipril after TAVI in patients with preserved LV function?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 186
186 patients (108 female, 78 male).
Inclusion criteria: patients after successful TAVI with preserved LV function.
Key exclusion criteria: mitral disease requiring intervention; ventricular ejection fraction ≤ 40%; prior STEMI or dilated cardiomyopathy; presence of MRI incompatibilities at baseline.
Interventions
N=94 ramipril (titration of dose to aim at 10 mg/day if tolerated).
N=92 standard care (no RAS inhibitor use).
Primary outcome
Cardiac death, heart failure readmission, and stroke at 1 year
10.6%
12%
12.0 %
9.0 %
6.0 %
3.0 %
0.0 %
Ramipril
Standard
care
No significant
difference ↔
No significant difference in cardiac death, HF readmission, and stroke at 1 year (10.6% vs. 12%; RR 0.88, 95% CI -4.85 to 6.61).
Secondary outcomes
No significant difference in cardiac death at 1 year (1.1% vs. 2.2%; RR 0.5, 95% CI -1.4 to 2.4).
Significant decrease in readmission due to HF at 1 year (3.2% vs. 10.9%; RR 0.29, 95% CI 0.01 to 0.57).
No significant difference in improvement in 6-minute walking test distance at 1 year (40 m vs. 71 m; AD -31 m, 95% CI -95.4 to 33.4).
Conclusion
In patients after successful TAVI with preserved LV function, ramipril was not superior to standard care with respect to cardiac death, HF readmission, and stroke at 1 year.
Reference
Ignacio J Amat-Santos, Diego López-Otero, Luis Nombela-Franco et al. Ramipril After Transcatheter Aortic Valve Implantation in Patients Without Reduced Ejection Fraction: The RASTAVI Randomized Clinical Trial. J Am Heart Assoc. 2024 Oct;13(19):e035460.
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