Advertisement

Advertisement

October 18, 2011

VIVA 2011: Intermediate Outcomes for Plaque Excision in DEFINITIVE LE

October 19, 2011—Principal Investigator Lawrence A. Garcia, MD, presented intermediate results from DEFINITIVE LE in a late-breaking trial session at VIVA 2011: Vascular Interventional Advances meeting in Las Vegas, Nevada. The study evaluates the intermediate and long-term effectiveness of stand-alone treatment using the catheter-based SilverHawk/TurboHawk plaque excision systems (Covidien, Mansfield, MA) for endovascular treatment of peripheral arterial disease (PAD), specifically in the femoropopliteal and tibial-peroneal arteries.

The prospective, multicenter, postmarket study will determine the 1-year patency rates in patients with claudication and limb salvage in patients with critical limb ischemia (CLI). Independent duplex and angiographic core laboratories will assess 6- and 12-month patency. Device and procedural success will also be assessed. Other measurements include Rutherford-Becker (RB) clinical category, ankle-brachial index (ABI), and the Walking Impairment Questionnaire (WIQ), and an analysis of the impact of diabetes.

The DEFINITIVE LE investigators enrolled 800 patients with 1,011 target lesions ≤ 20 cm in length at 47 centers in the United States and Europe. At baseline, the mean RB category was 3.1. Of the 800 patients, 25% had CLI; 52.3% had diabetes; 91.8% had hypertension and 83% hyperlipidemia. The mean lesion length was 7.4 cm; 27.9% (282) of all lesions were > 10 cm in length. Time-to-event analyses including the primary endpoints were conducted using Kaplan-Meier methods.

Dr. Garcia reported that in 642 patients who had a 6-month follow-up, primary patency in claudicants was 94.1% at 180 days (94.4% in diabetics and 93.7% in nondiabetics) and 87.6% at 210 days, which was the end of the 6-month visit window (87.1% in diabetics and 88.1% in nondiabetics). Freedom from clinically driven target lesion revascularization among claudicants was 96.3% at 180 days and 92.1% at 210 days.

For patients with CLI, freedom from major unplanned amputation of the target limb at 6 months was 97.3%. Mean RB clinical category improved from 3.1 to 1.4 (P < .001) and mean ABI from 0.64 to 0.77 (P < .001). All WIQ domains (pain, walking speed, walking distance, and stair climbing) significantly improved (P < .001), the DEFINITIVE LE investigators found.

“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," commented Dr. Garcia. Covidien advised that the final 12-months results will be available in approximately 1 year. The study seeks to verify the effectiveness of plaque excision as a frontline therapy for the treatment of PAD, the company noted.

Advertisement

Advertisement

Subscribe to our weekly newsletter.

Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Plus, get our latest issues & supplements delivered to your inbox each month.

Subscribe