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Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09\u00b19.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p&lt;0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter \u22644.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.<\/jats:p>","DOI":"10.1177\/1526602820931477","type":"journal-article","created":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T05:41:23Z","timestamp":1593063683000},"page":"693-705","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":65,"title":["Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort"],"prefix":"10.1177","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7513-5063","authenticated-orcid":false,"given":"Giovanni","family":"Torsello","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery, St Franziskus-Hospital M\u00fcnster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9775-9210","authenticated-orcid":false,"given":"Konstantinos","family":"Stavroulakis","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, St Franziskus-Hospital M\u00fcnster, Germany"},{"name":"Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Brodmann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Medical University, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Micari","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Humanitas Gavazzeni Hospital, Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1239-994X","authenticated-orcid":false,"given":"Gunnar","family":"Tepe","sequence":"additional","affiliation":[{"name":"Institute of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2780-6421","authenticated-orcid":false,"given":"Pierfrancesco","family":"Veroux","sequence":"additional","affiliation":[{"name":"Vascular Surgery and Transplant Unit, University of Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Benko","sequence":"additional","affiliation":[{"name":"Division of Interventional Radiology, Facult\u00e9 de Medecine, Universit\u00e9 de Sherbrooke, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donghoon","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Yonsei University Hospital, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank E. 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