4-year Long Outcome with Drug Coated Balloons for Sfa Lesions in Patients with CLI: Comparison with Conventional Bypass Surgery

Introduction: Endovascular treatment of symptomatic peripheral artery disease has gained widespread acceptance. The efficacy and safety of drug coated balloon angioplasty in the setting of critical limb ischemia in comparison to conventional surgery was previously demonstrated with favorable 1-year outcomes. Evidence however remains limited on the durability of the treatment effect in these stettings in the longer term. We have compared our 4-year long results with DCB angioplasty to conventional bypass surgery in patients with critical limb ischemia. 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 preformed over a 6 year-period. A 72% of all bypasses were performed using saphenous vein grafts with above-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%, 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; 82.7% vs. 82.8% at 24 months, (P=0.28) and remained similar at 4 years (66.4% vs.68.8, P=0.08), respectively. Freedom from clinically-driven TLR at 12 months was similar in both groups (87.6% vs. 85%, P=0.33). The rates of clinically driven target lesion revascularization were 29.2% and 26.1% (P=0.07) for the DCB and surgery groups, respectively. Conclusion: Drug coated balloon angioplasty yields comparable results to surgery in the setting of critical ischemia even at 4 years. The efficacy and the safety of DCB's in more complex lesions is to be investigated with randomized trials. Disclosure: Nothing to disclose