MedStar Authors catalog › Details for: 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.
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. Journal: Cardiovascular revascularization medicine : including molecular interventions. Published: 2017 ISSN: 1878-0938. UI/PMID: 28923692. Subject(s): Aged | *Cardiovascular Agents/ad [Administration & Dosage] | Cardiovascular Agents/ae [Adverse Effects] | *Coronary Angiography | Coronary Artery Disease/dg [Diagnostic Imaging] | Coronary Artery Disease/mo [Mortality] | *Coronary Artery Disease/th [Therapy] | Coronary Restenosis/dg [Diagnostic Imaging] | Coronary Restenosis/et [Etiology] | Coronary Restenosis/pc [Prevention & Control] | *Coronary Vessels/dg [Diagnostic Imaging] | Drug Administration Schedule | Drug Therapy, Combination | *Drug-Eluting Stents | Feasibility Studies | Female | Humans | Male | Middle Aged | Percutaneous Coronary Intervention/ae [Adverse Effects] | *Percutaneous Coronary Intervention/is [Instrumentation] | Percutaneous Coronary Intervention/mo [Mortality] | Platelet Aggregation Inhibitors/ad [Administration & Dosage] | Predictive Value of Tests | Prospective Studies | Prosthesis Design | Risk Factors | Sirolimus/ad [Administration & Dosage] | Sirolimus/ae [Adverse Effects] | *Sirolimus/aa [Analogs & Derivatives] | Time Factors | Treatment Outcome | Ultrasonography, Interventional | United States Institution(s): MedStar Union Memorial Hospital | MedStar Southern Maryland Hospital Center | MedStar Health Research Institute | MedStar Heart & Vascular Institute Activity type: Journal Article. Medline article type(s): Journal Article Digital Object Identifier: https://dx.doi.org/10.1016/j.carrev.2017.07.017 (Click here) Abbreviated citation: ; Cardiovasc Revasc Med. 18(7):475-481, 2017 Oct - Nov. Local Holdings: Available in print through MWHC library: 2002 - present. Abstract: 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. Abstract: 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. Abstract: 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 mm<sup>3</sup>).
Abstract: 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.