Edwards Lifesciences’ (NYSE:EW) Sapien transcatheter aortic valve implantation system, the only TAVI device on the U.S. market, demonstrated sustained and increasing survival benefits out to 3 years among inoperable heart failure patients, according to newly unveiled study results.
Data from Cohort B of Edwards’ Partner trials showed that the 1-year survival benefit seen in prior studies was sustained out to 3 years and increased over time, with a widening gap in mortality benefit for TAVI patients compared with a "standard therapy" group.
At 12 months, the all-cause mortality rate for TAVI patients was 30.7%, compared with 50.8% among the control arm. By 24 months rates had increased to 43% for TAVI and 68% for the control arm, and at 3 years, rates were reported at 54.1% for TAVI and 80.9% for the control group. The data illustrated a gap that widened from 20.1% to 25% at 2 years and to 26.8% at 3 years.
Cardiovascular mortality showed a similar trend, with a 12-month rate of 20.5% for TAVI and 44.6% for the control, compared with a 3-year rate of 41.4% for TAVI and 74.5% for the control, representing gaps of 24.1% and 33.1%. The data was released during the Transcatheter Cardiovascular Therapeutics conference in Miami this week.
"The 3-year data further highlight the devastating effects of symptomatic severe aortic stenosis in patients receiving only standard therapy – reinforcing the important role that transcatheter valve replacement plays in the treatment of these patients," Edwards chairman & CEO Michael Mussallem said in a press release.
Patients in the TAVI arm also had lower rates of repeat hospitalization and improved functional status, Cohort B investigator Dr. Murat Tuzcu of the Sydell and Arnold Heart & Vascular Institute at the Cleveland Clinic said in prepared remarks.
The trial included 358 patients with severe, symptomatic aortic stenosis who were deemed too sick for open heart surgery. The patients were randomized to receive either TAVI treatment or standard medical therapy.
The study was more good news for Edwards, which earlier this month announced that the FDA had granted expanded approval for the Sapien system to treater lower-risk patients.
EW shares got a little bump yesterday, closing at $86.22, up 1.4% on the day. Shares were hovering around that mark of about noon today.