Primary stent-supported angioplasty for treatment of below-knee critical limb ischemia and severe claudication

OBJECTIVES The objective of this study was an investigation of the safety and efficacy of primary below-knee stent-supported angioplasty (BKSSA) for restoring straight inline arterial flow in patients with critical limb ischemia (CLI) or lifestyle-limiting claudication (LLC). BACKGROUND Surgical tibial bypass for CLI and severe LLC is associated with significant morbidity, mortality, and graft failure, whereas percutaneous angioplasty is suboptimal. METHODS Below-knee stent-supported angioplasty was attempted in 82 patients (92 limbs) with either CLI (68%) or severe LLC (32%). Patients received daily aspirin, thienopyridine, and glycoprotein IIb/IIIa agents during the procedure. One-month major adverse events (MAEs) were defined as death, myocardial infarction, major unplanned amputation, need for surgical revascularization, or major bleeding. Clinical success was defined as improved resting ankle brachial index by greater than or equal to0.10, relief of resting pain, healing of ulceration or amputation, and improvement of claudication. RESULTS Mean age of patients was 74 +/- 17 years. In 86 limbs, straight inline flow was restored to at least one tibial vessel. Technical success was 94% for de novo lesions and there were no MAEs. Ankle brachial indexes increased for all groups (CLI = 0.32 +/- 0.13 to 0.9 +/- 0.14 and LLC = 0.65 +/- 0.09 to 0.95 +/- 0.12; p less than or equal to 0.0001, pre vs. post). Relief of rest pain and healing of ulcerations and amputations were seen in 96% (47 of 49) of patients with CLI who underwent successful intervention. CONCLUSIONS Below-knee stent-supported angioplasty for CLI and LLC improves ankle brachial indexes comparable to tibial bypass, heals amputations and ulcerations, relieves rest pain, and improves ambulation. Because BKSSA is associated with minimal MAE, it may hold promise as an alternative therapy for patients with CLI and LLC. (C) 2004 by the American College of Cardiology Foundation.