TY - BOOK AU - Bastian, Roshni AU - Chandra, Nina AU - Garcia-Garcia, Hector M AU - Leiboff, Roy AU - Spad, Mia-Ashley AU - Torguson, Rebecca AU - Waksman, Ron AU - Wang, John TI - Polymer-free Biolimus A9-coated stents in the treatment of de novo coronary lesions with short DAPT: 9-month angiographic and clinical follow-up of the prospective, multicenter BioFreedom USA clinical trial SN - 1878-0938 PY - 2017/// KW - *Cardiovascular Agents/ad [Administration & Dosage] KW - *Coronary Angiography KW - *Coronary Artery Disease/th [Therapy] KW - *Coronary Vessels/dg [Diagnostic Imaging] KW - *Drug-Eluting Stents KW - *Percutaneous Coronary Intervention/is [Instrumentation] KW - *Sirolimus/aa [Analogs & Derivatives] KW - Aged KW - Cardiovascular Agents/ae [Adverse Effects] KW - Coronary Artery Disease/dg [Diagnostic Imaging] KW - Coronary Artery Disease/mo [Mortality] KW - Coronary Restenosis/dg [Diagnostic Imaging] KW - Coronary Restenosis/et [Etiology] KW - Coronary Restenosis/pc [Prevention & Control] KW - Drug Administration Schedule KW - Drug Therapy, Combination KW - Feasibility Studies KW - Female KW - Humans KW - Male KW - Middle Aged KW - Percutaneous Coronary Intervention/ae [Adverse Effects] KW - Percutaneous Coronary Intervention/mo [Mortality] KW - Platelet Aggregation Inhibitors/ad [Administration & Dosage] KW - Predictive Value of Tests KW - Prospective Studies KW - Prosthesis Design KW - Risk Factors KW - Sirolimus/ad [Administration & Dosage] KW - Sirolimus/ae [Adverse Effects] KW - Time Factors KW - Treatment Outcome KW - Ultrasonography, Interventional KW - United States KW - MedStar Health Research Institute KW - MedStar Heart & Vascular Institute KW - MedStar Southern Maryland Hospital Center KW - MedStar Union Memorial Hospital KW - Journal Article N1 - Available in print through MWHC library: 2002 - present N2 - BACKGROUND: BioFreedom is a polymer- and carrier-free drug-coated stent that delivers Biolimus A9 to the vessel wall. Our purpose was to evaluate the efficacy and safety of this DCS in patients with short-duration dual antiplatelet therapy; CONCLUSIONS: This study's angiography and IVUS assessments demonstrated that the BioFreedom DCS has anti-restenotic efficacy similar to first-generation DES. In the absence of concerning safety signals, this DCS should be considered effective and safe for patients who require a shorter duration of DAPT. Copyright (c) 2017 Elsevier Inc. All rights reserved; METHODS: The BioFreedom US IDE feasibility trial was a single-arm, open-label, prospective study of patients requiring stenting of de novo lesions. Patients received 3 months of DAPT, repeat angiography at 9 months, and clinical follow-up at multiple intervals. A subgroup also underwent intravascular ultrasound (IVUS) interrogation. The primary safety end point was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, or stent thrombosis. The primary efficacy end point, in-stent late lumen loss at 9 months, was compared with a historical control from a first-generation paclitaxel-eluting stent; RESULTS: A total of 72 patients from 10 sites received BioFreedom DCS implanted in 83 de novo lesions. At 9 months, the incidence of composite MACE was 8.4%, and TLR was 1.5%. Short DAPT was safe without occurrence of stent thrombosis. The primary end point of LLL was 0.32+/-0.53 mm. Paired IVUS analyses comparing postprocedural with 9-month measurements showed low in-stent neointimal volume obstruction (5.39+/-5.28%) and low neointimal hyperplasia (7.43+/-8.04 mm3) UR - https://dx.doi.org/10.1016/j.carrev.2017.07.017 ER -