Trial Demonstrates Positive Results For Treating Peripheral Arterial Disease In Leg
Peripheral Arterial Disease
Edwards Lifesciences Corporation announced the 12-month results from The RESILIENT Trial, presented as the "Blockbuster" Trial of the Day at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The landmark trial demonstrates statistically superior results using the LifeStent self-expanding stent versus balloon angioplasty alone in treating peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery. These arteries are the major circulatory channels for the upper leg and knee.
"The RESILIENT Trial is a randomized, multi-center study using the flexible LifeStent self-expanding stent in the understudied and challenging SFA region," said Barry T. Katzen, M.D., Founder and Medical Director of Baptist Cardiac and Vascular Institute, and co-principal investigator for The RESILIENT Trial. "The results of this trial show the statistical superiority of the LifeStent self-expanding stent versus balloon angioplasty alone as the need for follow-up intervention was 13% versus 54%, respectively, at 12 months."
The RESILIENT Trial further demonstrated the SFA patency rate, or percentage of vessels with unobstructed blood flow, was 80% for patients who received the LifeStent self-expanding stent versus 38% for patients with balloon angioplasty alone.
"Results from The RESILIENT Trial are expected to establish the LifeStent self-expanding stent as an alternative for patients evaluating treatment options for SFA disease," said co-principal investigator John R. Laird, M.D., Medical Director of the Vascular Center at the University of California, Davis Medical Center. "Millions of patients suffering from PAD are in need of a clinically proven therapy that will improve their quality of life, allow them to be more active and walk without pain."
"We are very pleased with the 12-month results of The RESILIENT Trial, which provide clinicians with the highest level of clinical data available for a therapy to treat PAD patients less invasively," said Stuart L. Foster, Edwards' corporate vice president, Critical Care and Vascular.
The LifeStent self-expanding nitinol stent is a percutaneously-delivered flexible mesh tube that expands when deployed to prop open a diseased vessel and is specifically designed to withstand bending and twisting of the SFA. In 2004, Edwards initiated The RESILIENT Trial enrolling 246 patients at 25 sites, including 134 LifeStent self-expanding stent patients randomized against 72 balloon angioplasty patients.
The SFA is the major artery providing blood flow to the leg and extends behind the knee as the popliteal artery. This is a common area of blockage, or significant narrowing of the artery, in patients who suffer from atherosclerosis of the lower extremities, causing moderate to severe pain due to poor blood flow in the leg muscles. It is estimated that approximately 8 million Americans suffer from lower-extremity PAD, which affects mostly men and women older than 50 years. Without an effective treatment, PAD can develop into critical limb ischemia, a severe obstruction of the arteries with decreased blood flow to the lower extremities that may result in amputation.
Edwards is currently in discussions with the U.S. Food and Drug Administration (FDA) for premarket approval of its LifeStent system with an SFA indication.