The final outcome of primary infrainguinal percutaneous transluminal angioplasty in 100 consecutive patients with chronic critical limb ischemia

PURPOSE: This study was performed to determine final outcomes in patients treated with infrainguinal percutaneous transluminal angioplasty (PTA) for chronic critical limb ischemia (CLI). MATERIALS AND METHODS: The study population consisted of 100 consecutive patients (mean age, 72 y; range, 38-90 y, 40 men and 60 women) with 116 treated limbs. CLI was defined as rest pain or ischemic tissue defect combined with an ankle systolic pressure less than or equal to 50 mm Hg. Indication for treatment was rest pain in 23 limbs (20%), ischemic ulcer in 50 (43%), and gangrene in 43 (37%). All patients were followed until they had met the study endpoints: major amputation or death. The mean follow-up period was 38 months (1-119 mo). Limb salvage, survival, and life with limb rates were determined along with their determinants. RESULTS: On average, 1.9 invasive procedures were required during the lifespan of a critically ischemic limb, including primary PTA and 32 repeat PTA procedures, 11 surgical revascularizations, and 51 amputations. The major amputation rate was 32% (n = 37). Limb salvage for endovascular treatments at 3, 5, and 8 years was 65%, 60%, and 60%, respectively (SE of estimate [SEE] less than or equal to 0.06), and the corresponding life with limb rates were 29%, 18%, and 6% (SEE less than or equal to 0.05). A greater number of diseased vessels in the treated limb was associated with poorer limb salvage (P = .004). Survival rates were 41%, 26%, and 14% (SEE less than or equal to 0.05) at 3, 5, and 10 years. The 10-year survival rate was markedly poorer than that in the age- and sex-matched control population. Coronary artery disease (P = .001) and poor peripheral runoff (P = .02) were associated with decreased survival. CONCLUSIONS: Infrainguinal PTA in patients with CLI results in acceptable limb salvage with a low number of additional revascularization treatments, but patient survival is poor.