Abstract

Objective: Critical Limb Ischemia (CLI) remains a difficult disease to treat with limited level-1 data. The 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. Methods: Using statewide data, all patients were identified with lower extremity ulcers and a diagnosis of peripheral arterial disease that underwent a revascularization procedure from 2005- 2013. Propensity scores were formulated from baseline patient characteristics. 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. Results: A total of 16,800 patients were identified. Open surgical bypass was the initial treatment in 5,970 (36%) patients while 10,830 (64%) underwent endovascular interventions. Patients in the endovascular group were slightly younger compared to the open group (70 vs. 72 years, sd = 12 years, p<0.001). Endovascular patients were more likely to have renal failure (36 % vs. 24%) and coronary artery disease (34 % vs. 32%), while patients in the open bypass group were more likely to have diabetes mellitus (30% vs. 44%, all p values <0.05). After propensity weighting, open first treatment was associated with lower rates of reintervention (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.83 to 0.91); however, surgery first was associated with a lower AFS (HR; 1.16, 95% CI: 1.12- 1.2). (Image) Initial treatment at a high-volume center was associated with improved amputation free survival compared to medium (HR 1.3, CI: 1.21-1.36) or low (1.2, CI: 1.1-1.3) volume centers. Conclusions: Patients with CLI have multiple comorbidities, and initial surgical bypass is associated with poorer quality of amputation free survival compared to an endovascular first approach. Treatment in high volume centers improves amputation free survival. This may be due to improved resources at high volume centers.

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