One-Year REPRISE III Data Presented for Boston Scientific's Lotus TAVR System

May 16, 2017—Boston Scientific Corporation announced that results from the REPRISE III clinical trial were presented at the EuroPCR 2017 conference in Paris, France. According to the study data, the company's Lotus transcatheter aortic valve replacement (TAVR) system demonstrated superiority for the primary effectiveness endpoint and noninferiority for the primary safety endpoint compared with the CoreValve TAVR system platform (Medtronic).

The multicenter, randomized controlled REPRISE III trial included 912 patients with severe aortic stenosis who were considered to be at high or extreme risk for surgical valve replacement. Patients were enrolled from the United States, Europe, Canada, and Australia.

The primary effectiveness endpoint, a composite of all death, disabling stroke, and moderate or greater paravalvular aortic leakage (PVL) at 1 year, was lower with the Lotus valve system compared with the CoreValve platform (16.7% vs 29%; P < .001). Lotus demonstrated noninferiority to CoreValve for the primary safety endpoint, which was a composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications through 30 days.

In the prespecified secondary endpoint, the Lotus valve system had significantly lower rates of moderate to severe PVL occurrences compared with the CoreValve platform (2% vs 11.1%; P < .001).

Ted E. Feldman, MD, Co-Investigator of the REPRISE III trial, commented in the company's announcement, "The excellent results seen in this large randomized trial, particularly the superior performance in efficacy and the continued demonstration of low PVL rates, further establish the advantages of the Lotus valve system." He added, "With the Lotus valve system, I have confidence that I can position the valve accurately in every case and achieve good outcomes for my patients." Dr. Feldman is Director of the Cardiac Catheterization Laboratory at NorthShore University HealthSystem in Evanston, Illinois.

The Lotus valve system is not available for sale, advised Boston Scientific.