Covidien (NYSE:COV), a leading global provider of healthcare products, today released the six-month results of the DEFINITIVE(TM) LE (Determination of Effectiveness of SilverHawk Peripheral Plaque Excision System for the Treatment of Infrainguinal Vessels/Lower Extremities) study, the largest global post-market peripheral arterial disease (P.A.D.) device study ever undertaken.
Enrolling 800 patients at 47 centers in both the U.S. and Europe, with data reviewed by independent core laboratories, the landmark study is an important step in verifying the effectiveness of plaque excision as a frontline therapy for the treatment of P.A.D. The results were announced during the Late-Breaking Clinical Trials session at the Vascular InterVentional Advances (VIVA) conference.
“Representing one of the largest cohorts of patients reported on a single peripheral device, DEFINITIVE LE is designed to provide a large pool of robust, core-lab verified clinical data,” said Lawrence Garcia, MD, Principal Investigator and Chief of Interventional Cardiology and Vascular Interventions at St. Elizabeth’s Medical Center in Boston.
The prospective, multi-center, post-market study reports six-month patency rates in patients with claudication, as well as limb salvage rates in patients with critical limb ischemia. These rates are noted after treatment with Covidien’s catheter-based SilverHawk(R)/TurboHawk(R) Plaque Excision Systems. The study took 800 subjects with 1,011 target lesions (up to 20 cm in length) and had a pre-specified sub-analysis done to compare patency outcomes in patients with diabetes to those without diabetes. Time-to-event analyses including the primary endpoints were conducted using Kaplan-Meier methods; 624 subjects had a six-month follow-up and primary patency in claudicants was 94.1 percent at 180 days. There was no difference in six-month patency outcomes between patients with or without diabetes. For patients with critical limb ischemia, freedom from major unplanned amputation of the target limb at six months was 97.3 percent. The final results at 12 months will be available about a year from now.
“We are pleased to see the six-month results of this trial, especially around the diabetic patient cohorts. The results are promising in this large cohort of advanced disease in challenging lesions,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “It’s exciting to be able to demonstrate equivalent findings in a complex patient population of diabetic patients when compared to non-diabetics, given that all other stent and percutaneous transcatheter angioplasty trials have demonstrated worse outcomes in the diabetic patients.”
P.A.D. is one of the most common vascular diseases and occurs when leg arteries become narrowed or blocked by plaque. These blockages can result in severe pain for patients, limited physical mobility and non-healing leg ulcers. According to the American Heart Association, approximately 10 million people in the U.S. suffer from P.A.D.
DEFINITIVE LE is a groundbreaking study in terms of size, patient population and the clinical rigor of execution; it is unique among other atherectomy studies conducted to date. This study is evaluating the one-year patency rates in patients with claudication and limb salvage in patients with critical limb ischemia after treatment with Covidien’s catheter-based SilverHawk/TurboHawk Plaque Excision Systems.