In this study, researchers report the 2-year outcomes for patients enrolled in the Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients), which show that transcather aortic valve replacement (TAVR) with a supra-annular, self-expanding valve is noninferior to surgical aortic valve replacement (AVR).
A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An attempted implant was performed in 730 TAVR and 684 surgical AVR patients.
Rates for death or disabling stroke at 2-years follow-up were 4.3% in the TAVR group and 6.3% in the surgical AVR group.
These rates were similar to a Bayesian analysis performed after 850 patients had reached 1-year follow-up, which were 5.3% with TAVR and 6.7% with surgical AVR.
All-cause mortality rates were 3.5% vs 4.4%, and disabling stroke rates were 1.5% vs 2.7%, respectively, for TAVR vs surgical AVR.
The complete 2-year follow-up finds that TAVR is noninferior to surgical AVR for all-cause mortality or disabling stroke, with event rates that were slightly better than the Bayesian analysis at 1-year follow-up, the researchers say.Read More >>