Procedural and Clinical Outcomes with Catheter-Based Plaque Excision in Critical Limb Ischemia:

Purpose:To examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (CLI).Methods:Between August 2003 and August 2004, a prospective evaluation was conducted of consecutive patients with CLI (Rutherford category ≥5) who were treated with endovascular plaque excision at 7 institutions. This study enrolled 69 patients (37 women; mean age 70±12 years, range 43–93) with CLI involving 76 limbs. Clinical outcomes were prospectively followed for 6 months. The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days. Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed.Results:Procedural success was achieved in 99% of cases. Major adverse events occurred in 1% of patients at 30 days and 2...