It’s the fallout period after the ACC Scientific Sessions meeting, the time when companies issue press releases to make sure we don’t miss what they’re up to. And in cardiology world there’s not much to trump transcatheter heart valves when it comes to innovation. Edwards Lifesciences Corporation updates us with news of its lower profile valve, and results of its 3 year Sapien study.
So, first up, Sapien XT: Edwards announced preliminary results from its PARTNER II Trial studying transcatheter aortic valve replacement (TAVR) in inoperable patients with severe, symptomatic aortic stenosis. Findings were presented as a late-breaking clinical trial at the American College of Cardiology’s (ACC) Scientific Session over the weekend and demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards SAPIEN XT transcatheter aortic valve and the Edwards SAPIEN valve. Notably though, there were fewer vascular events with the lower-profile SAPIEN XT valve (major vascular events 9.6% vs 15.5%, p value 0.04) .
The PARTNER II Trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the United States between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the SAPIEN valve, and 284 received the SAPIEN XT valve.
Sapien XT remains investigational in the U.S., while its big brother Sapien is approved for use in patients considered inoperable or at high risk when undergoing conventional valve surgery.
In a second presentation at ACC, Edwards saw the three-year results of its PARTNER pivotal clinical study of 699 severe aortic stenosis patients at high-risk for surgery presented as a late-breaking trial. The results continue to demonstrate comparable outcomes between treatment with the Edwards SAPIEN transcatheter heart valve and open-heart surgery. These new data from The PARTNER Trial showed three year, all-cause mortality for patients treated with the Edwards SAPIEN TAVR delivered via the femoral artery or a small incision between the ribs was statistically equivalent to that of patients who had received open-heart surgical aortic valve replacement (AVR).
Symptom improvement and valve performance was similar in both groups and was maintained through the three years of patient follow-up. The incidence of stroke between TAVR and surgery patients was also comparable. The one remaining elephant in the room is paravalvular leak, where, unsurprisingly the incidence of leakage that started dramatically higher than in conventional valve surgery at 30 days, remains so at 3 years, albeit not quite as dramatic.
“These three-year data from The PARTNER Trial strengthen the evidence that the SAPIEN valve is a safe and less-invasive alternative for those patients who need valve replacement, but are at high surgical risk,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “The availability of the SAPIEN valve encourages the many untreated patients to work with a Heart Team to determine whether transcatheter valve replacement or surgery is the right option for them.”
Source: Edwards Lifesciences Corporation