May 15, 2024Open Access
Long-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement: Meta-analysis of Randomized Trials
Resultado clave
Transcatheter aortic valve replacement showed no significant difference in long-term death or disabling stroke compared to surgical aortic valve replacement (HR 1.02; 95% CI 0.93-1.11; P=.70).
Diseño del estudio
Tipo
Meta-Analysis (n=7,785)
PICO estructurado
Does transcatheter aortic valve replacement improve long-term outcomes (death or disabling stroke) compared to surgical aortic valve replacement in patients with severe aortic stenosis?
P
Población
7,785 patients with severe aortic stenosis pooled from 7 randomized controlled trials
I
Intervención
Transcatheter aortic valve replacement (TAVR), including self-expanding and balloon-expandable valves
C
Comparador
Surgical aortic valve replacement (SAVR)
O
Resultado
Composite of death or disabling stroke at longest available follow-up (weighted mean 5.76 years)composite
At nearly 6 years of follow-up, TAVR and SAVR demonstrate similar rates of death or disabling stroke for severe aortic stenosis, though TAVR is associated with higher rates of pacemaker implantation and paravalvular leaks.
Resultado numérico
Estimación del efecto: HR 1.02 (95% CI 0.93-1.11)
valor p: p=.70
Resumen
BackgroundWe aimed to perform a meta-analysis of randomized trials comparing long-term outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) for severe aortic stenosis. The short-term efficacy and safety of TAVR are proven, but long-term outcomes are unclear.MethodsWe included randomized controlled trials comparing TAVR vs SAVR at the longest available follow-up. The primary end point was death or disabling stroke. Secondary end points were all-cause mortality, cardiac mortality, stroke, pacemaker implantation, valve thrombosis, valve gradients, and moderate-to-severe paravalvular leaks. The study is registered with PROSPERO (CRD42023481856).ResultsSeven trials (N = 7785 patients) were included. Weighted mean trial follow-up was 5.76 ± 0.073 years. Overall, no significant difference in death or disabling stroke was observed with TAVR vs SAVR (HR, 1.02; 95% CI, 0.93-1.11; P = .70). Mortality risks were similar. TAVR resulted in higher pacemaker implantation and moderate-to-severe paravalvular leaks compared to SAVR. Results were consistent across different surgical risk profiles. As compared to SAVR, self-expanding TAVR had lower death or stroke risk (P interaction = .06), valve thrombosis (P interaction = .06), and valve gradients (P interaction < .01) but higher pacemaker implantation rates than balloon-expandable TAVR (P interaction < .01).ConclusionsIn severe aortic stenosis, the long-term mortality or disabling stroke risk of TAVR is similar to SAVR, but with higher risk of pacemaker implantation, especially with self-expanding valves. As compared with SAVR, the relative reduction in death or stroke risk and valve thrombosis was greater with self-expanding than with balloon-expandable valves.