Long-term and Landmark Analysis of Transcatheter versus Surgical Aortic-Valve Replacement in Severe Aortic Stenosis

Abstract

BackgroundPrevious reports of long-term outcomes of TAVR focus on higher risk patients and suggest potential temporal changes. The indications of TAVR have expanded to low-risk patients. We aimed to evaluate the long-term and temporal performances of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR).MethodsRandomized controlled trials reporting outcomes with at least 1-year follow-up were included. The primary outcome was the composite of all-cause death or disabling stroke.ResultsWe included 8 trials with 8,749 patients. TAVR was associated with a higher risk of long-term (5-year) primary outcome compared to SAVR among higher-risk (odds ratio [OR], 1.25; 95% CI, 1.07–1.47) but not lower-risk participants (1.0 [0.77–1.29]). However, a significant temporal interaction was detected in both risk profiles. TAVR with balloon-expandable valves was associated with a higher risk of long-term primary outcome compared to SAVR (1.38 [1.2–1.6]), whereas no statistical difference was found with self-expanding valves (1.03 [0.89–1.19]). There was a significant interaction between the two valve systems, and a temporal interaction was detected in both systems. Overall landmark analysis revealed a lower risk in TAVR within the initial 30 days (0.76 [0.6, 0.96]), comparable between 30 days to 2 years (1.04 [0.85, 1.28]), and higher beyond 2 years (1.36 [1.15– 1.61]). Analysis for all-cause death generated largely similar results.ConclusionsTAVR was associated with a higher long-term risk of primary outcome compared to SAVR in higher-risk patients and with balloon-expandable valves. However, a characteristic temporal interaction was documented in all subgroups. Future studies are warranted to test these findings.