Subset Analysis of DEFINITIVE LE Supports Directional Atherectomy in Diabetic Patients

October 27, 2015—In the International Society of Endovascular Specialists’ Journal of Endovascular Therapy (JEVT), Lawrence A. Garcia, MD, et al published findings from a comparison of clinical outcomes for diabetic and nondiabetic patients after directional atherectomy in the DEFINITIVE LE claudicant cohort (2015;22:701–711). This subset analysis evaluated the hypothesis that directional atherectomy for peripheral artery disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants.

As summarized in JEVT, the multicenter DEFINITIVE LE study was conducted in the United States and Europe to assess the effectiveness of directional atherectomy using SilverHawk/TurboHawk systems (Medtronic plc) for the treatment of peripheral artery disease in the superficial femoral, popliteal, and infrapopliteal arteries. In August 2014, Co-Global Principal Investigator James F. McKinsey, MD, et al published the DEFINITIVE LE study in the Journal of the American College of Cardiology: Cardiovascular Interventions (2014;7:923–933).

Of the 800 patients enrolled in the DEFINITIVE LE study, only 598 claudicant patients (mean age, 69.5 ± 10.4 years; 336 men) who were classified at baseline as Rutherford category 1–3 were eligible for this subset analysis. Of these, 46.8% (280/598) had diabetes.

Follow-up at 12 months included duplex ultrasound examination, functional assessments, and adverse event evaluations. Independent angiographic and duplex ultrasound core laboratories assessed primary patency and secondary endpoints; a clinical events committee adjudicated adverse events.

The investigators reported in JEVT that although diabetics had significantly more baseline comorbidities, 12-month primary patency was no different than for nondiabetics (77% vs 77.9%, respectively; superiority P-superiority = .98; P-noninferiority < .001) across all anatomic territories treated. Freedom from clinically driven target lesion revascularization was no different between diabetics and nondiabetics (83.8% vs 87.5%) overall (P = .19) or by lesion locations. Secondary clinical outcomes (Rutherford category, ankle-brachial index, and walking impairment) improved at 12 months for both diabetics and nondiabetics.

The noninferior 12-month patency rates demonstrate that directional atherectomy is an effective treatment in diabetic as well as nondiabetic claudicants; therefore, directional atherectomy remains an attractive treatment option, improving luminal diameters without stents, which preserves future treatment options for both diabetic and nondiabetic patients with progressive, diffuse vascular disease, concluded the investigators in JEVT.