[Clinical outcome of percutaneous revascularization by stent-assisted balloon angioplasty of femoro-popliteal and tibial vessels in diabetic patients with critical limb ischemia].

Background: The aim of this study was to assess the long-term clinical outcome of percutaneous peripheral interventions in diabetic patients with critical limb ischemia (CLI) in terms of occurrence of major amputation and mortality.
Methods: From January 2004 to December 2007, all diabetic patients undergoing peripheral angiography and percutaneous revascularization for the presence of CLI were enrolled in this registry and followed prospectively. Limb salvage, mortality, and repeat revascularization were reported at long term.
Results: 267 diabetic patients (mean age 72.2 +/- 9.6 years) with 290 ischemic limbs represent the study population. Hypertension was present in 227 patients (85%), hypercholesterolemia in 85 (32%), chronic renal failure in 61 (23%). Ischemic heart disease was present in 80 patients (30%), carotid disease in 75 (28%). According to the Texas Diabetic Ulcers Classification, 203 patients (70%) had type CIII lesion, 29 (10%) CII, 9 (3%) CI, 20 (7%) DIII, 23 (8%) DII, and 6 (2%) DI; 440 lesions (169 tibial arteries, 261 femoro-popliteal arteries, and 10 iliac arteries) were dilated with stent implantation in 290 of them (66%). The procedure was successful in 415 (94%) with restoration of direct flow in at least one tibial artery. The ankle-brachial index was 0.32 +/- 0.11 before procedure and increased to 0.77 +/- 0.23 (p<0.001). One patient died suddenly during hospital stay. Mean follow-up length was 17 +/- 11 months. Of the 290 limbs, major amputation was necessary in 17 (6%) of which 10 had an unsuccessful procedure. Amputation was fatal in 7 cases (41%). Complete foot lesion healing was obtained in 238 (82%) and partial healing in 35 (12%). Death occurred in 42 patients (16%) and it was related to cardiac events in 16 (6%), cerebrovascular events in 8 (3%), acute renal failure in 8 (3%), and cancer in 10 (4%). Repeat revascularization occurred in 67 patients (23%) in the target limb and in 29 (11%) in the contralateral limb.
Conclusions: Peripheral angioplasty with stent implantation is an effective procedure for limb salvage in diabetic patients with CLI. The high mortality is probably related to the systemic atherosclerosis process with involvement of coronary and cerebral circulation that leads to heart and cerebral fatal ischemic events.