Boston Scientific Announces Positive Results from REPRISE III Trial

Boston Scientific has announced positive results from the REPRISE III clinical trial, presented at the annual EuroPCR Scientific Program, in Paris. Data from the study demonstrated that the LOTUS Valve System, a transcatheter aortic valve implantation (TAVI) system, showed superiority over the CoreValve TAVI System platform for the primary effectiveness endpoint and non-inferiority for the primary safety endpoint. The primary effectiveness endpoint, a composite of all death, disabling stroke and moderate or greater paravalvular aortic leakage (PVL) at one year, was lower with the LOTUS Valve system compared to the CoreValve platform (16.7% vs. 29.0%, p<0.001).

The LOTUS Valve system also demonstrated noninferiority to CoreValve platform for the primary safety endpoint which was a composite of all-cause mortality, stroke, lifethreatening and major bleeding events, stage two or three acute kidney injury or major vascular complications through 30 days.

The pre-specified secondary endpoint demonstrated the LOTUS Valve system had significantly lower rates of moderate to severe PVL occurrences when compared to the CoreValve platform (2.0% vs. 11.1%, p<0.001).

REPRISE III is the first head-to-head pivotal study comparing two different TAVI platforms: the LOTUS Valve system and the CoreValve platform, including both CoreValve and EvolutR. It is a multi-center, randomized controlled trial that included 912 patients from the United States, Europe, Canada and Australia with severe aortic stenosis who were considered to be at high or extreme risk for surgical valve replacement.

Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart.