LEA 2. Four-Year-Long Outcome With Drug-Coated Balloons for Superficial Femoral Artery Lesions in Patients With Critical Limb Ischemia: Comparison With Conventional Bypass Surgery

Abstract

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 were previously demonstrated with favorable 1-year outcomes. Evidence remains limited, however, on the durability of the treatment in the longer term. We have compared our 4-year-long results with DCB angioplasty with conventional bypass surgery in patients with critical limb ischemia. A total of 187 patients with CLI treated during 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 an endovascular approach with the use of IN.PACT Admiral (Medtronic Inc, Santa Rosa, Calif). Data collection was achieved prospectively. A total of 210 procedures (100 surgery, 110 endovascular) were preformed during a 6-year period; 72% of all bypasses were performed using saphenous vein grafts, with above-knee bypass as the technique of choice in 80% of the cases. A 6-mm DCB was used in 41% of the patients. Procedural success rates (98% vs 99%; P = NS) as well as clinical success rates (99% vs 99%; NS) and operative mortality (3.7% vs 2%; P = NS) were similar in both groups. Primary patency for DCB angioplasty vs bypass was 91.8% vs 88.9%, respectively, at 12 months (P = .31) and 82.7% vs 82.8% at 24 months (P = .28); it remained similar at 4 years (66.4% vs 68.8%; P = .08). Freedom from clinically driven target lesion revascularization at 12 months was similar in both groups (87.6% vs 85%; P = .33). The rates of clinically driven target lesion revascularization were 29.2% and 26.1% (P = .07) for the DCB angioplasty and surgery groups, respectively. DCB angioplasty yields comparable results to surgery in the setting of critical ischemia even at 4 years. The efficacy and safety of DCBs in more complex lesions are to be investigated with randomized trials.