Covidien Announces Final Results from DEFINITIVE LE Study in Patients with PAD
Confirms Effectiveness of Directional Atherectomy with SilverHawk™ and TurboHawk™ Devices as a Frontline Therapy when Treating PAD
LAS VEGAS - October 10, 2012 - Covidien announced final 12-month results from its DEFINITIVE LE (Determination of Effectiveness of SilverHawk™ / TurboHawk™ Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities) study.
DEFINITIVE LE is the largest peripheral atherectomy study conducted to date with independent physician review of the outcomes. The study, which enrolled 800 patients at 47 centers in the U.S. and Europe, demonstrated the long-term effectiveness of directional atherectomy as a frontline therapy for the treatment of peripheral arterial disease (PAD).
“For the first time, the DEFINITIVE LE study has provided robust evidence within a large and diverse PAD patient population,” said Lawrence A. Garcia, MD, Chief of Interventional Cardiology and Vascular Interventions at St. Elizabeth's Medical Center in Boston. “Directional atherectomy, with the SilverHawk and TurboHawk devices, delivers patency results at 12 months post-treatment that are comparable to those reported in stent studies — and with the important advantage of not leaving anything behind in the vessel.”
DEFINITIVE LE 12-Month Efficacy and Safety Results
Clinical outcomes were improved by 30 days and sustained through 12 months of follow-up. Directional atherectomy with the SilverHawk and TurboHawk devices delivered 12-month patency results that were comparable to those reported in stent studies.
Among patients with claudication, primary patency was 78% using a peak systolic velocity ratio (PSVR) < 2.4 at 12 months. Notably, this rate did not differ between patients with diabetes (77%) and those without diabetes (78%) — the first such results to be shown in a prospective, powered analysis. Among patients with critical limb ischemia (CLI), 95% were able to avoid a major unplanned amputation of the target limb. The SilverHawk and TurboHawk devices were shown to have a strong safety profile in the study, with low complication rates.
"DEFINITIVE LE confirmed equivalent outcomes between diabetics and non-diabetics in terms of patency and persistent clinical improvement up to 12 months after treatment,” said Prof. Thomas Zeller, MD, Head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad Kronzingen, Bad Krozingen, Germany.
Dr. Garcia and Prof. Zeller, together with Dr. James McKinsey, Chief of the Division of Vascular Surgery and Endovascular Interventions at New York-Presbyterian Hospital/Columbia University Medical Center, served as Co-Principal Investigators for the DEFINITIVE LE study.
DEFINITIVE LE Study Design
The prospective, multi-center study comprised two cohorts — those with claudication and those with CLI. A total of 1,022 lesions (up to 20 cm in length) were treated with the Covidien SilverHawk or TurboHawk Plaque Excision device. The study included a broad patient population, with 52% diabetic, 45% female and 75% claudicants, and a pre-specified sub-analysis comparing patency outcomes in diabetic and non-diabetic patients.
Several controls were included to ensure rigor in the study. These included Steering Committee oversight, adverse event adjudication by an independent physician Clinical Events Committee and endpoint analyses conducted by two different independent core laboratories — one that analyzed acute angiographic results and another that analyzed duplex ultrasound follow-up.
Final results from the landmark study were presented today during the Late-Breaking Clinical Trials session at the Vascular InterVentional Advances (VIVA) Conference in Las Vegas.
