Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: Angiographic and clinical results

PURPOSE: To evaluate the safety and efficacy of infrapopliteal percutaneous transluminal angioplasty (PTA) as a primary treatment of chronic critical limb ischemia in a prospective trial. MATERIALS AND METHODS: Infrapopliteal PTA was performed on 72 limbs of 60 p atients (mean age, 72 y; range, 38-92 y) and patients were followed for 12- 24 months, RESULTS: The primary angiographic success rate for the stenoses was 84% (10 2 of 121) and that for the occlusions was 61% (41 of 67) with corresponding restenosis rates of 32% and 52% at follow-up angiography performed a mean of 10 months after primary PTA. The rate of major complications was 2.8% (a ccess site pseudoaneurysms in two patients). The primary clinical success w as 63% (45 of 72), A 48% cumulative primary patency rate, a 56% secondary p atency rate, and a 80% cumulative limb salvage rate were registered at 18 m onths, as determined with use of Kaplan-Meier analysis, Lack of angiographi c improvement at the site of the most severe ischemia and renal insufficien cy (serum creatinine level >130 mu mol/L) were independent predictors of po orer long-term clinical results, as determined with use of Cox multiple reg ression analysis. CONCLUSIONS: Infrapopliteal PTA is a feasible primary treatment of chronic critical limb ischemia with moderate primary angiographic and clinical succ ess, a low complication rate, and a cumulative limb salvage rate comparable with surgical techniques.