|Covidien Announces Final Results from Landmark DEFINITIVE LE Study in Patients with Peripheral Arterial Disease|
Study Confirms Effectiveness of Directional Atherectomy with SilverHawk ™ and TurboHawk ™ Devices as a Frontline Therapy when Treating PAD
DEFINITIVE LE study confirms that directional atherectomy with
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
“For the first time, the DEFINITIVE LE study has provided robust
evidence within a large and diverse PAD patient population,” said
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 (i.e., the treated artery remained open) 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 - a severe form of PAD), 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.
According to the
"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.
Dr. Garcia and Prof. Zeller, together with Dr.
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.
"We are pleased with the long-term results from our groundbreaking
DEFINITIVE LE study, which is unique among atherectomy studies conducted
to date because of the size of the study and the clinical rigor of
Final results from the landmark study were presented today during the Late-Breaking Clinical Trials session at the Vascular InterVentional Advances (VIVA) Conference here.
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