PURPOSE: To determine the clinical outcomes and success rates after percutaneous subintimal angioplasty (SIA) in patients with lower-limb occlusive lesions causing intermittent claudication (IC) or critical limb ischemia (CLI) at midterm to long-term follow-up. The secondary aim was to elicit factors predictive of a successful outcome. MATERIALS AND METHODS: Between January 1999 and June 2006, 75 consecutive patients (45 men; age range, 46-91 years; CLI in 79%) underwent SIA of iliac and infrainguinal (84%) occlusions. Outcomes were determined on an intent-to-treat basis. The composite endpoint of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up, which was defined as the development of IC, CLI, or need for subsequent endovascular or surgical revascularization. Actuarial freedom from MACO was assessed via Kaplan-Meier curves and multivariable Cox proportional-hazards regression. RESULTS: SIA was performed on 75 lesions, with an initial procedure success rate of 83% (n = 62). Procedure failure was caused by heavily calcified lesions (n = 5) and failure of reentry (n = 8). A total of 56.3% of patients with claudication were free from ipsilateral claudication at follow-up (mean, 32 months; range, 1-64 months), and those with CLI had a 79.7% limb salvage rate at a mean follow-up of 30.7 months (range, 0.5-91 months). On Cox regression analysis, the following variables were identified as independent predictors of MACO within the limb treated with SIA: ABI after SIA (hazard ratio, 0.21; 95% CI, 0.05-0.89; P = .035) and number of patent runoff vessels (ie, </=1 vs >/=2; hazard ratio, 0.29; 95% CI, 0.15-0.59; P = .001). CONCLUSIONS: SIA is a feasible therapeutic option for occlusive atherosclerotic lesions in IC and CLI and is the evolving preferred strategy in CLI and perhaps IC with long-segment occlusions.
PURPOSE: To determine the clinical outcomes and success rates after percutaneous subintimal angioplasty (SIA) in patients with lower-limb occlusive lesions causing intermittent claudication (IC) or critical limb ischemia (CLI) at midterm to long-term follow-up. The secondary aim was to elicit factors predictive of a successful outcome. MATERIALS AND METHODS: Between January 1999 and June 2006, 75 consecutive patients (45 men; age range, 46-91 years; CLI in 79%) underwent SIA of iliac and infrainguinal (84%) occlusions. Outcomes were determined on an intent-to-treat basis. The composite endpoint of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up, which was defined as the development of IC, CLI, or need for subsequent endovascular or surgical revascularization. Actuarial freedom from MACO was assessed via Kaplan-Meier curves and multivariable Cox proportional-hazards regression. RESULTS: SIA was performed on 75 lesions, with an initial procedure success rate of 83% (n = 62). Procedure failure was caused by heavily calcified lesions (n = 5) and failure of reentry (n = 8). A total of 56.3% of patients with claudication were free from ipsilateral claudication at follow-up (mean, 32 months; range, 1-64 months), and those with CLI had a 79.7% limb salvage rate at a mean follow-up of 30.7 months (range, 0.5-91 months). On Cox regression analysis, the following variables were identified as independent predictors of MACO within the limb treated with SIA: ABI after SIA (hazard ratio, 0.21; 95% CI, 0.05-0.89; P = .035) and number of patent runoff vessels (ie, </=1 vs >/=2; hazard ratio, 0.29; 95% CI, 0.15-0.59; P = .001). CONCLUSIONS: SIA is a feasible therapeutic option for occlusive atherosclerotic lesions in IC and CLI and is the evolving preferred strategy in CLI and perhaps IC with long-segment occlusions.