Edwards heart valve trial results impress
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A heart valve replacement technique developed by Edwards LifeSciences Corp that spares patients open-heart surgery had a slightly lower death rate at one year, outweighing a higher risk of major stroke.
One year after implantation using the Edwards valve called Sapien, 24.2 percent of patients died—compared with 26.8 percent of those who underwent open-heart surgery in the highly anticipated 699-patient study.
Non-inferiority of the Edwards device was “strongly established,” according to researchers who presented the data at the American College of Cardiology Scientific Sessions.
The Edwards device led to twice as many major strokes—5.1 percent versus 2.4 percent for surgery—potentially making surgery preferable for some patients.
But researchers and doctors said the stroke implications were not yet fully understood and that recovery times and hospital stays were dramatically shorter for patients who do not undergo the procedure in which the chest must be sawed open and the heart stopped.
“It takes half a year to get back to full activity after open heart surgery. But we see these patients getting mobilized in a few days,” said Dr. Mogen Larsen, head of cardiology at Odense University Hospital in Denmark, who has been implanting the Edwards valve, which is approved in Europe, for more than two years.
The 699-patient clinical trial, dubbed Partner, compared high-risk elderly subjects who had their diseased aortic valves replaced using the Edwards noninvasive transcatheter valve system with those who had conventional open-heart surgery.
Dr. Edwin Dizon, a cardiologist at Philippines Heart Center in Manila attending the meeting, called the Edwards valve data “quite impressive” despite the potentially heightened chance of stroke “because the benefit exceeds the risk, and it prolongs life.”
In addition to higher stroke risk, 11 percent of patients who got the Edwards valve had major vascular complications after 30 days, compared with 3.2 percent of the surgery group.
But there were also additional clinical advantages seen with the Edwards system, in which the valve is threaded through arteries to the heart with a catheter and implanted inside the old, diseased valve.
New incidences of atrial fibrillation—potentially dangerous irregular heart rhythms that can lead to stroke and other problems—occurred in 8.6 percent of those who got the Edwards valve versus 16.0 percent in the surgery group. They also had far less major bleeding than the surgery group—9.3 percent compared with 19.5 percent.
A previous study of the Edwards system proved to be far superior to standard drug therapy for aortic stenosis in patients deemed too ill to undergo major surgery.
But it remains to be seen whether the Food and Drug Administration will embrace the new technique in patients for whom surgery remains an option, given the heightened stroke risk seen in the study.
Susan Housholder-Hughes, a nurse practitioner at the University of Michigan in Ann Arbor, is clearly in favor of approval.
“These are elderly patients that don’t have much stamina and until now they have had to undergo open heart surgery, which is like getting hit by a truck,” she said.
“The less invasive procedure should offer them a quicker recovery and get them back on their feet and doing the things they enjoy and want to do.”
Edwards is hoping the totality of the data will work in its favor. The Sapien system is expected to be an important future growth driver for the company, and how widely its use is approved by the FDA will likely be an important factor in just how big a product it can become.
U.S. approval for the Edwards system that is expected to cost about $30,000, and competes with a similar system developed by Medtronic Inc’s CoreValve unit in Europe, could come later this year.
Dr Craig Smith, one of the principal researchers of the study, said he expects the Edwards system to help tens of thousands of patients within a short time after U.S. approval and in a few years “hundreds of thousands.”
(Reporting by Debra Sherman, Bill Berkrot and Ransdell Pierson; Editing by Eric Walsh, Maureen Bavdek and Gunna Dickson)
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By Debra Sherman and Bill Berkrot
NEW ORLEANS
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