DEFINITIVE LE Subgroup Data Support Directional Atherectomy of Infrapopliteal Artery Lesions

December 3, 2015—One-year effectiveness outcomes from a subgroup of patients who underwent directional atherectomy of infrapopliteal artery lesions in the DEFINITIVE LE trial were published by Aljoscha Rastan, MD, et al in the Journal of Endovascular Therapy (JEVT, 2015;22:839-846).

The prospective, multicenter, single-arm 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. Follow-up assessments occurred up to 1-year postprocedure.

As summarized in JEVT, of the 800 patients enrolled in DEFINITIVE LE, 145 patients with 189 infrapopliteal lesions met the criteria for this analysis. Seventy patients (48.3%) had critical limb ischemia (CLI); 75 patients (51.7%) experienced intermittent claudication; and 99 patients (68.3%) had diabetes. The mean lesion length was 58 ± 44 mm (all lesions); 20.2% of lesions were occluded.

The primary endpoint for patients with claudication was duplex ultrasound–derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed. 

Procedural success (defined as ≤ 30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants, 89.6% and CLI patients, 78%; P = .11), and the freedom from major amputation rate was 97.1% (claudicants, 100% and CLI, 93.8%; P = .03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline.

This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicants as well as CLI patients, concluded the investigators in JEVT.

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).