Transcatheter aortic valve replacement was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years (4.3% vs 6.3%; P=0.084).
RCT (n=1,414)
randomized
Does transcatheter aortic valve replacement reduce the composite of all-cause mortality or disabling stroke compared to surgical aortic valve replacement in low-surgical risk patients with severe aortic stenosis?
In low-surgical risk patients with severe aortic stenosis, TAVR with a self-expanding valve is noninferior to surgical aortic valve replacement for the composite of death or disabling stroke at 2 years.
Absolute Event Rate: 4.3% vs 6.3%
p-value: p=0.084
BACKGROUND The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. OBJECTIVES The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. METHODS A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. CONCLUSIONS The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients Evolut Low Risk Trial; NCT02701283).
Forrest et al. (2022) conducted an RCT in severe aortic stenosis (n=1,414). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (AVR) was evaluated on all-cause mortality or disabling stroke (p=0.084). Transcatheter aortic valve replacement was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years (4.3% vs 6.3%; P=0.084).