Clinical outcome following infra-inguinal percutaneous transluminal angioplasty for critical limb ischemia.

Objective: The aim of this study was to assess the efficacy and durability of infra-inguinal PTA in patients with CLI, in terms of clinical outcome.
Design: Retrospective study of 50 consecutive patients with CLI that were exclusively treated by infra-inguinal PTA.
Methods: The indications for intervention were rest pain in seven (14%) patients, non-healing ulcers in 27 (54%), and gangrenous lesions in 16 (32%). Thirty-three (66%) of these patients presented with a single arterial lesion, and the remaining 17 (34%) with multilevel arterial lesions. Kaplan-Meier analysis was used to assess survival, patency, limb-salvage rates, and amputation-free survival.
Results: A total of 67 endovascular procedures were performed and 59 (88.1%) of them were considered to be technically successful. The median follow-up period was 12 months (interquartile range: 17 months). The 30-day mortality was 4%, while the cumulative survival rates at 12, 24, and 36 months were 73%, 67%, and 59%, respectively. The cumulative primary patency rates at 12 and 24 months were 63% and 52%, respectively, and remained unchanged thereafter. The estimated secondary patency rate was 72% at 36 months. There was only one below-knee amputation in the patients that were treated exclusively with infra-inguinal PTA. The cumulative amputation-free survival at the same period was estimated at 60%.
Conclusions: Infra-inguinal PTA had a good early and late outcome in this series of patients with a limited life expectancy. These results are comparable to historical results of surgical revascularization in the treatment of CLI. There is need for a randomized study to determine the primary optimal interventional approach for patients with CLI.