Document Type
Article
Publication Title
Journal of the American College of Cardiology
Abstract
BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process.
OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial.
METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years.
RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were
CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
First Page
1663
Last Page
1674
DOI
10.1016/j.jacc.2023.02.017
Publication Date
5-2-2023
Recommended Citation
Forrest, John K; Deeb, G Michael; Yakubov, Steven J; Gada, Hemal; Mumtaz, Mubashir A; Ramlawi, Basel; Bajwa, Tanvir; Teirstein, Paul S; DeFrain, Michael; Muppala, Murali; Rutkin, Bruce J; Chawla, Atul; Jenson, Bart; Chetcuti, Stanley J; Stoler, Robert C; Poulin, Marie-France; Khabbaz, Kamal; Levack, Melissa; Goel, Kashish; Tchétché, Didier; Lam, Ka Yan; Tonino, Pim A L; Ito, Saki; Oh, Jae K; Huang, Jian; Popma, Jeffrey J; Kleiman, Neal; and Reardon, Michael J, "3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis." (2023). Heart and Vascular Articles. 10.
https://scholarlyworks.ohiohealth.com/heart-vascular-articles/10