What's next after optimal infrapopliteal angioplasty? Clinical and ultrasonographic results of a prospective single-center study.

PURPOSE: To evaluate arterial patency and factors influencing outcomes after successful tibial artery angioplasty in patients with critical limb ischemia (CLI). METHODS: From January 2005 to August 2007, a prospective single-center study was conducted involving 80 CLI patients (56 men; mean age 71.7+/-8.8 years) who underwent successful tibial artery angioplasty (<30% residual stenosis) in 87 limbs. Eighty (92%) limbs showed ischemic ulcers or gangrene at baseline. In two thirds, a more proximal lesion was treated, and a secondary stent was implanted in 14 (16%). Follow-up included clinical examination for wound healing (WH), limb salvage (LS), and duplex-documented target vessel patency or restenosis at discharge and at 1, 3, 6, 9, 12, 18, and then every 6 months. Patency rates, WH, and LS were assessed with the Kaplan-Meier method, and factors influencing these outcomes were analyzed using Cox proportional hazards models. RESULTS: Mean follow-up was 10.9 months (range 2 days - 29 months). At 12 months, the primary and assisted primary patency rates were 37.9% and 71.2%, respectively. Restenosis was significantly correlated with smoking (HR 3.58, 95% CI 1.15 to 11.18; p = 0.02), infected ulcers (HR 2.04, 95% CI 1.02 to 4.09; p = 0.04), and posterior tibial artery angioplasty (HR 3.76, 95% CI 1.59 to 8.87; p = 0.003). Rates of LS and WH at 12 months were 92.7% and 74.9%, respectively. Peroneal angioplasty was significantly correlated with WH (HR 1.83, 95% CI 1.04 to 3.25; p = 0.03), and wound healing increased with classes of age (HR 1.60, 95% CI 1.07 to 2.39; p = 0.02). CONCLUSION: One-year restenosis after optimal tibial artery angioplasty is significant and positively correlated with smoking, infection of trophic lesions, and posterior tibial artery angioplasty. Close ultrasound surveillance provides good limb salvage after optimal infrapopliteal angioplasty in patients with CLI.