New Insights from Real-World Femoral-Popliteal Drug-Coated Balloon Treatment: 1-Year Results from IN.PACT Global Study, Including Long Lesions

Abstract

Purpose Randomized trial data have demonstrated superior safety and efficacy of IN.PACT Admiral Drug-coated Balloon (DCB; Medtronic, Santa Rosa, California) vs. PTA for the revascularization of mostly TransAtlantic InterSociety Consensus (TASC) A-B femoro-popliteal lesions in patients with claudication and rest pain. A prospective, single-arm study, the IN.PACT global study, was conceived to expand the appraisal of DCB towards the real-world treatment of patients with the same peripheral artery disease symptoms, including those patients with lesions > 15 cm in length. Material and Methods The IN.PACT global study is a rigorous, independently adjudicated and monitored multicenter, international, 1500 patient, single-arm study of DCB revascularization of femoro-popliteal stenosis and occlusions with a minimum length of 2 cm. One-year results from the first 655 patients enrolled are presented. The majority had severe (58.2%) or moderate (27.3%) claudication or ischemic rest pain (10.9%) at baseline, and 41.2% were diabetic. The mean lesion length was 12.23 cm, 35.8% of lesions were total occlusions, and 21.4% of lesions represented in-stent restenosis. The primary endpoint was clinically driven target lesion revascularization at 12 months. Results At 12 months, the rate of clinically driven target lesion revascularization was 8.7%. An analysis by lesion length on the subset of subjects (N=514) with unilateral limb treatment of single lesions was also performed. The clinically driven target lesion revascularization rate in lesion lengths greater than 15 cm was 11.5% (22/191), confirming the performance of the IN.PACT Admiral DCB in long lesions. Conclusions Preliminary results from the IN.PACT Global Study indicate that the IN.PACT Admiral DCB is safe and efficacious in the treatment of real-world femoro-popliteal lesions, and continues to perform well in long lesions.