Primary infrainguinal subintimal angioplasty in diabetic patients.

The aim of this study was to prospectively evaluate technical and clinical results of infrainguinal subintimal angioplasty in a series of diabetic patients with limb-threatening ischemia. From July 2003 to December 2007, 60 consecutive diabetic patients (M/F = 41/19; mean age, 69.4 +/- 9.4 years) with Fontaine stage IV critical limb ischemia, not suitable for surgical recanalization, underwent primary infrainguinal subintimal angioplasty. The technical success, perioperative morbidity and mortality, and clinical success (defined by ulcer healing) were evaluated. Kaplan-Meier life-table analysis was obtained for cumulative clinical success, limb salvage, and survival rates. The procedure was technically successful in 55 of 60 (91.7%) patients; in 5 cases we were not able to achieve a reentry. Periprocedural mortality was 5% (3 patients); three patients (5%) required major amputation periprocedurally. Mean follow-up was 23 months (range, 0-48 months). On an intention-to-treat basis, the limb salvage rate was 93.3% (56/60 patients); ulcer healing was observed in 45 of 60 (75%) patients and it was significantly (p < 0.05) associated with serum creatinine and HbA1c levels, diabetes duration, and infrapopliteal recanalization. One- and three-year cumulative survival rates were 91.5% and 83.1%, respectively; serum creatinine levels, patient age, and clinical success were significant predictors of survival. In conclusion, infrainguinal primary subintimal angioplasty is a safe and effective treatment in diabetic patients with limb-threatening ischemia not suitable for surgical recanalization. This procedure is aimed to create a "temporary bypass" that facilitates ulcer healing.