Like Dr. Popma, Dr. Williams welcomed the June 17 approval of the Sapien 3 TAVR system, based on 30-day outcomes from all 583 patients enrolled in the U.S. pivotal trial. Results from that study became public last March in a late-breaker report at the American College of Cardiology meeting.
Mitchel L. Zoler/Frontline Medical News
Dr. Susheel Kodali
Sapien 3 treatment of high-risk, symptomatic patients, who averaged 83 years old and had a STS predicted mortality rate of 8.6%, resulted in a 2% mortality rate, a 1.5% stroke rate, a 3% rate of moderate or severe paravalvular leaks, and 13% of patients had a new need for a pacemaker, Dr. Susheel Kodali reported when he presented these data in March. Trial investigators were able to place the Sapien 3 aortic valve via a transfemoral approach in 491 of the 583 patients (84%) enrolled in the study. The adverse outcomes with Sapien 3 contrasted with rates for the prior Sapien XT TAVR system of 3.5% for 30-day mortality, 4.3% for strokes, and a 24% rate of moderate or severe paravalvular leak, said Dr. Kodali, director of the heart valve program at Columbia University in New York.
While the Sapien 3 and Evolut systems appeared to produce roughly similar outcomes for parameters like 30-day mortality, stroke, and paravalvular leak rates, with both systems outperforming what they displaced, the Evolut has two important differences, compared with Sapien 3. First, the Evolut is slightly smaller, with the ability to traverse arteries as narrow as 5 mm, whereas the minimum vessel size for Sapien 3 passage is 5.5 mm; second, Evolute is repositionable, while Sapien 3 is not.
The CoreValve Evolut R trials were sponsored by Medtronic. Dr. Popma has received research grants from and served as a speaker on behalf of Medtronic. He has also been a speaker for Abbott Vascular, Boston Scientific, Covidien, Cook Medical, and Direct Flow Medical and has received research support from five other companies. Dr. Williams has been a consultant to and received research support from Medtronic and has also been a consultant to Edwards and Direct Flow Medical. The Sapien 3 trial was sponsored by Edwards. Dr. Kodali has received research support from Edwards, has an equity interest in Thubrikar Aortic Valve, has received honoraria from St. Jude, and has served on the steering committee for trials sponsored by Claret Medical and Meril.
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