Midterm results with drug-coated balloons for SFA lesions in patients with CLI: comparison with conventional bypass surgery

BACKGROUND: Endovascular treatment of symptomatic peripheral artery disease has gained widespread acceptance. The efficacy and safety of drug-coated balloon (DCB) angioplasty in the setting of critical limb ischemia in comparison to conventional surgery has not been demonstrated. We have compared our results with DCB angioplasty to conventional bypass surgery in patients with critical limb ischemia (CLI). METHODS: A total of 187 patients with CLI treated over a 6-year period between 2006 and 2012 by a single operative team constituted the study population. Between 2006 and 2009, all patients underwent conventional surgery. Between 2009 and 2012, the investigators adopted endovascular approach with the use of IN.PACT Admiral (Medtronic Inc., Santa Rosa, CA, USA). Data collection was achieved prospectively. RESULTS: A total 210 procedures (100 surgery, 110 endovascular) were performed over a 6-year period. A 72% of all bypasses were performed using saphenous vein grafts with above-the-knee bypass as the technique of choice in 80% of the cases. 6-mm DCB was used in 41% of the patients. Procedural success rates (98% vs. 99%, NS) as well as clinical success rates (99% vs. 99%, P=NS) and operative mortality (3.7% vs. 2%, NS) was similar in both groups. Primary patency for DCB vs. bypass groups 91.8% vs. 88.9%, respectively (P=0.31) at 12 months and 82.7% vs. 82.8% at 24 months, respectively (P=0.28). Freedom from clinically-driven target lesion revascularization at 12 months was similar in both groups (87.6% vs. 85%, P=0.33). Primary patency for DCB vs. bypass groups at 24 months was 82.7% vs. 82.8%, respectively (P=0.28). CONCLUSIONS: DCB angioplasty yields comparable results to surgery in the setting of critical ischemia. The efficacy and the safety of DCBs in more complex lesions is to be investigated with randomized trials.