The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience.

OBJECTIVE: To determine the efficacy, safety, and long-term results, including continued clinical improvement and limb salvage, of percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI).

METHODS: From August 1993 to March 2004, 138 limbs in 111 patients with CLI (rest pain in 62 [45%] and ulcer/gangrene in 76 [55%]) were treated by PTA. In iliac lesions, stents were placed selectively for primary PTA failure: residual stenosis (>30%) or pressure gradient (>5 mm Hg). Stent placement was limited in infrainguinal lesions. The most distal affected arteries treated with angioplasty were the iliac artery in 45 limbs (33%; iliac group), the femoropopliteal artery in 41 limbs (30%; FP group), and tibial arteries in 52 limbs (37%; BK group). All analysis was performed according to an intent-to-treat basis. Reporting standards of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery were followed to evaluate initial success, and late follow-up status was evaluated with the Kaplan-Meier method. Patency was evaluated by using ultrasound scanning and ankle-brachial pressure index measurement.

RESULTS: There was one (0.9%) perioperative death. Twenty stents were placed selectively in 14 iliac arteries. Mean follow-up was 14.7 months (range, 1-75 months). Overall, initial technical and clinical success rates were 96.4% and 92.8%, respectively. The cumulative primary, assisted primary, and secondary patency; continued clinical improvement; and limb salvage rates +/- SE at 5 years were 31.4% +/- 10.4%, 75.5% +/- 5.7%, 79.6% +/- 5.5%, 36.1% +/- 10.0%, and 89.1% +/- 4.0%, respectively. In each subgroup, the primary, assisted primary, and secondary patency; continued clinical improvement; and limb salvage rates at 3 years were 51.6%, 94.7%, 97.8%, 65.1%, and 95.0%, respectively, in the iliac group; 49.4%, 72.2%, 76.4%, 57.4%, and 92.7%, respectively, in the FP group; and 23.5%, 41.8%, 46.1%, 51.1%, and 77.3%, respectively, in the BK group. Of the 12 predictable variables, hypertension, multiple segment lesions, more distal lesions, and TransAtlantic Inter-Society Consensus classification type D were significant independent risk factors for the outcomes ( P < .05; univariate log-rank test and Cox regression multivariate analysis).

CONCLUSIONS: PTA is a feasible, safe, and effective procedure for the treatment of CLI. The high limb salvage rate is attributed to the high assisted primary and secondary patency rates despite the low primary patency rate. Angioplasty can be the primary choice for the treatment of CLI due to iliac and infrainguinal arterial occlusive disease.