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. 2009 Feb 15;73(3):406-12.
doi: 10.1002/ccd.21898.

Orbital Atherectomy for Infrapopliteal Disease: Device Concept and Outcome Data for the OASIS Trial

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Orbital Atherectomy for Infrapopliteal Disease: Device Concept and Outcome Data for the OASIS Trial

Robert D Safian et al. Catheter Cardiovasc Interv. .

Abstract

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 < or =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.

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