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 < or = 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] <or = 0.06), and the corresponding life with limb rates were 29%, 18%, and 6% (SEE < or = 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 < or = 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.