Date: 2014-08-18
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal of American College of Cardiology, Cardiovascular Interventions (JACC CI)
Company: Covidien (Ireland)
Product: TurboHawk™ and SilverHawk™ directional atherectomy systems
Action mechanism:
Disease: critical limb ischemia (CLI) peripheral arterial disease
Therapeutic area: Cardiovascular diseases
Country: USA,
Trial
details: The prospective, multi-center DEFINITIVE LE study enrolled 800 patients in 47 centers in U.S. and Europe and included two patient cohorts: those with claudication and those with CLI. Patients enrolled in the study were treated with the TurboHawk and/or SilverHawk, a catheter-based, minimally invasive treatment to remove plaque and restore blood flow, without leaving anything behind in patients with PAD. For the first time in an atherectomy study, DEFINITIVE LE also included pre-specified sub-group analysis comparing patency rates in diabetic and non-diabetic patients. The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs. (NCT00883246) DEFINITIVE LE is the largest study of a series of three studies, which includes DEFINITIVE Ca++ and DEFINITIVE AR. The DEFINITIVE series enrolled 1,054 patients in the U.S. and Europe to evaluate the effectiveness of directional atherectomy.
Latest
news: * On August 18, 2014, Covidien announced that results from the DEFINITIVE LE study using Covidien’s TurboHawk™ and/or SilverHawk™ directional atherectomy systems are published online in the Journal of American College of Cardiology, Cardiovascular Interventions (JACC CI). Results demonstrated 95 percent limb salvage in patients with critical limb ischemia (CLI) and 78 percent overall patency (the ability for the treated artery to remain open) in claudicant patients at 12 months. Patients enrolled in the study were treated with the TurboHawk and/or SilverHawk, a catheter-based, minimally invasive treatment to remove plaque and restore blood flow, without leaving anything behind in patients with PAD. For the first time in an atherectomy study, DEFINITIVE LE also included pre-specified sub-group analysis comparing patency rates in diabetic and non-diabetic patients. Among patients with claudication, primary patency was 78 percent at 12 months. Notably, this rate did not differ between patients with diabetes (77 percent) and those without diabetes (78 percent)—the first such results to be shown in a prospective, powered analysis. Specifically for the SFA, the patency rates were 83 percent in lesions under 10 cms in the claudicant cohort.
