DEFINITIVE LE study results show directional atherectomy is safe and effective in claudication and critical limb ischaemia patients


Directional atherectomy is safe and effective as a frontline therapy for the treatment of peripheral arterial disease, according to a multicentre study published online in the Journal of American College of Cardiology: Cardiovascular Interventions.

Results from the DEFINITIVE LE study using Covidien’s TurboHawk and/or SilverHawk directional atherectomy systems demonstrated 95% limb salvage in patients with critical limb ischaemia and 78% overall patency in claudicant patients at 12 months. The DEFINITIVE LE study is the largest atherectomy study conducted to date with independent, core lab analysis of the clinical outcomes.

“The DEFINITIVE LE study provides confirmatory evidence based on 12-month, independent core lab adjudicated data on the use of directional atherectomy in treating a diverse, real-world group of patients with peripheral arterial disease,” said James F McKinsey, co-global principal investigator and lead author of the study. “The study enrolled 800 patients, making it the largest trial with independent, core lab analysis for atherectomy to date. Results of the study demonstrate high limb salvage, patency rates, and diabetic outcomes. This further confirms the effectiveness and versatility of directional atherectomy in a wide range of vessel sizes and clinical presentations. Atherectomy is an important treatment option as the therapy leaves nothing behind in the body and preserves all future treatment options.”

The prospective, multicentre DEFINITIVE LE study enrolled 800 patients in 47 centres in the USA and Europe and included two patient cohorts: those with claudication and those with critical limb ischaemia. 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 peripheral arterial disease. For the first time in an atherectomy study, DEFINITIVE LE also included pre-specified subgroup analysis comparing patency rates in diabetic and non-diabetic patients.

“The outcomes for patients with claudication reveal that in the scientific landscape directional atherectomy is not only safe but effective to a similar degree as previous trials in the superficial femoral artery. Diabetic patients, who remain challenging for therapy due to their advanced and multilevel disease, have similar patency rates to non-diabetic patients with claudication when performing directional atherectomy,” said Lawrence Garcia, co-global principal investigator of the study and chief of Interventional Cardiology and Vascular Interventions at St Elizabeth’s Medical Center in Boston. “These findings provide strong clinical support for the versatility of directional atherectomy in treating patients with diabetes, claudication and critical limb ischaemia.”

Among patients with claudication, primary patency was 78% 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. Specifically for the superficial femoral artery, the patency rates were 83% in lesions under 10cm in the claudicant cohort.