Key result
Self-expanding TAVR matches SAVR for 5-year mortality and stroke in high-risk patients.
Why the study?
The CoreValve U.S. Pivotal High Risk Trial previously showed superior 1-year mortality of TAVR compared with SAVR in high-risk patients, motivating a comparison of mid-term 5-year safety, performance, and durability.
Does transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis improve 5-year survival, safety, performance, and durability compared to surgical aortic valve replacement (SAVR) in high-risk patients with severe aortic stenosis?
RCT (n=797)
1:1
Yes
Does transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis improve 5-year survival, safety, performance, and durability compared to surgical aortic valve replacement (SAVR) in high-risk patients with severe aortic stenosis?
In high-risk patients with severe aortic stenosis, self-expanding TAVR and SAVR demonstrated similar 5-year survival and stroke rates, with low rates of severe structural valve deterioration and valve reintervention in both groups.
Answers are grounded in this paper and cite their sources.
May inform high-risk aortic stenosis counseling; leaves open need for randomized long-term confirmation.
Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
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Gleason et al. (2018) conducted an RCT in Symptomatic severe aortic stenosis in high surgical risk patients (n=797). Transcatheter aortic valve replacement (TAVR) with self-expanding Medtronic CoreValve bioprosthesis vs. Surgical aortic valve replacement (SAVR) was evaluated on All-cause mortality at 5 years. Self-expanding TAVR resulted in similar 5-year all-cause mortality (55.3% vs 55.4%) and major stroke rates (12.3% vs 13.2%) compared with SAVR in high-risk patients.
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