Abstract

Critical limb ischemia remains a difficult disease to treat, with limited level 1 data. The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is attempting to answer whether initial treatment with surgical bypass or endovascular therapy improves outcomes. Although still in the enrollment phase, this study aims to compare amputation-free survival (AFS) and reintervention in patients treated with initial open surgical bypass or endovascular intervention for ischemic ulcers of the lower extremities. By use of statewide data, all patients were identified with lower extremity ulcers and a diagnosis of peripheral arterial disease who underwent a revascularization procedure from 2005 to 2013. Propensity scores were formulated from baseline characteristics of the patients. Inverse probability weighting was used within Kaplan-Meier analysis to determine AFS and time to reintervention for open vs endovascular treatment. Cox proportional hazards modeling was used to adjust for access to care and hospital revascularization experience. A total of 16,800 patients were identified. Open surgical bypass was the initial treatment of 5970 (36%) patients, whereas 10,830 (64%) underwent endovascular interventions. Patients in the endovascular group were slightly younger compared with the open group (70 vs 72 years; standard deviation, 12 years; P < .001). Endovascular patients were more likely to have renal failure (36% vs 24%) and coronary artery disease (34% vs 32%), whereas patients in the open bypass group were more likely to have diabetes mellitus (30% vs 44%; all P values < .05). After propensity weighting, open first treatment was associated with lower rates of reintervention (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.83-0.91); however, surgery first was associated with a lower AFS (HR, 1.16; 95% CI, 1.12-1.2; Fig). Initial treatment at a high-volume center was associated with improved AFS compared with medium-volume (HR, 1.3; CI, 1.21-1.36) or low-volume (HR, 1.2; CI, 1.1-1.3) centers. Patients with critical limb ischemia have multiple comorbidities, and initial surgical bypass is associated with poorer quality of AFS compared with an endovascular first approach. Treatment in high-volume centers improves AFS. This may be due to improved resources at high-volume centers.

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