It was good news and bad news for Edwards Lifesciences’ (NYSE:EW) Sapien transcatheter aortic valve implantation system at the American College of Cardiology conference today, as newly released data from the high-risk cohort of the Partner trial showed that the procedure stood up to surgical valve replacement after 2 years, but was also more prone to a type of valve leakage that could cause death.
The latest data showed that all-cause mortality for high-risk TAVI patients was 33.9%, compared with the 35% rate among patients who received open-heart surgery for aortic valve replacement, according to a press release.
The Partner A trials focused on a higher-risk patient population than Sapien is currently indicated for in the U.S.
"We are pleased that the growing body of longer-term evidence supports the Edwards Sapien transcatheter valve as an important therapy for high-risk patients," chairman & CEO Michael Mussallem said in prepared remarks. "Consistent with previous studies, the Partner trial also demonstrated that, even though seriously ill patients with aortic stenosis face dismal outcomes, many do not receive life-saving surgery because of other medical risks, age or preference. This underscores the value of an alternative therapeutic option for these high-risk patients."
The longer-term study also confirmed a lower stroke rate among TAVI patients, findings that were reiterated in Medtronic’s Advance TAVI trial and a Canadian registry of Sapien patients.
While the positive findings seemed to win the day, with EW shares trading 3.4% higher to $73.68 as of about noon today, the Partner A trial also noted a heightened risk of paravalvular leakage among TAVI patients, a condition that was linked to late mortality.
"The paravalvular-leak findings were a surprise," co-principal investigator Dr. Craig Smith told heartwire. "Of the concerns dogging TAVR, paravalvular leak was the one for which 2 answers were given: 1, it will become less frequent with time, experience, and modifications in design; and, 2, it doesn’t appear to matter anyway. For stroke and vascular complications, [the 2nd explanation] clearly never applied. We’re back to number 2 alone for paravalvular leak, which shouldn’t surprise us."
