Orbital atherectomy for infrapopliteal disease: Device concept and outcome data for the OASIS trial

Objective: The purpose of this study was to assess the safety and short‐term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease. Background: Infrapopliteal occlusive disease is a common cause of critical limb ischemia and claudication. There are no American College of Cardiology/American Heart Association guidelines for infrapopliteal revascularization for chronic limb ischemia. Methods: One hundred twenty four patients (201 stenoses) were enrolled in a prospective non‐randomized multicenter registry of orbital atherectomy for severe infrapopliteal disease. Data were collected as part of an investigational device exemption from the Food and Drug Administration. Results: The primary safety endpoint of major adverse events (MAE) at 30‐days (death, myocardial infarction, amputation, or repeat revascularization) was observed in four patients (3.2%). The primary efficacy endpoint (final diameter stenosis) was 17.8 ± 13.5%. The secondary endpoints of procedural success (final diameter stenosis ≤30%) and 6 month MAE (death, amputation, or target vessel revascularization) were observed in 90.1 and 10.4% of patients, respectively. Stand‐alone atherectomy was performed in 116 lesions (57.4%). At 6‐months, no patients required surgical bypass or unplanned amputation, and improvement in Rutherford ordinal scale was observed in 78.2% of patients. Conclusions: Orbital atherectomy is a unique approach to infrapopliteal disease, and provides predictable and safe lumen enlargement. Short‐term data demonstrate substantial symptomatic improvement and infrequent need for further revascularization or amputation. © 2009 Wiley‐Liss, Inc.