New clinical research, presented today at the 2017 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October- 2 November, Denver, USA), support the positive clinical performance of the Evolut transcatheter aortic valve implantation (TAVI) device (Medtronic) in aortic stenosis patients at intermediate risk. The data were from the SURTAVI (Surgical replacement and TAVI) trial and the Evolut R FORWARD “real-world” study.
Complete one-year outcomes from the SURTAVI trial based on Kaplan-Meier analyses confirmed, according to a press release, the strong performance of the CoreValve and Evolut R TAVI systems versus the gold standard of open heart surgery in an intermediate risk severe symptomatic aortic stenosis patient population. The results indicate that the platform continued to provide comparable results to surgery with regard to the primary combined endpoint of all-cause mortality or disabling stroke (7.8% for TAVI vs. 8.5% for surgery; p=0.55) at one year. A subgroup analysis of the SURTAVI continued access study (CAS) showed consistently positive safety data for the Evolut R system in intermediate-risk patients with high rates of survival (100%) and low rates of all stroke (1.5%) or disabling stroke (0.4%) at 30-days.
Additionally, a subanalysis from the SURTAVI trial where patients were stratified based on their STS Predicted Risk of Mortality (PROM) showed that TAVI patients demonstrated a significantly lower rate of all-cause mortality or disabling stroke at one year (1.5% vs. 6.5%; p=0.04) in the category of patients with STS-PROM < 3%. Patients treated with TAVI also showed mortality improvements across risk categories at one year whereas surgical mortality rates were similar across all STS score categories.
Similarly, results from a subset of 257 “real-world” patients enrolled in the Evolut R FORWARD Study with an STS PROM < 3% demonstrated excellent clinical outcomes with a low rate of all-cause mortality (2%) and disabling stroke (1.2%) at 30-days post implant.
Nicolas M Van Mieghem (Erasmus Medical Center, Rotterdam, the Netherlands) presenter of the SURTAVI one-year data at the meeting, comments: “With its supra-annular and self-expanding design, the Evolut TAVI platform is well-suited to deliver excellent valve performance for intermediate risk patients who are often considered to be more active than high- or extreme-risk patients. As new clinical data are gathered for this patient population, we continue to see the exceptional clinical benefits this self-expanding valve provides as a minimally-invasive treatment alternative to surgery.”