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. - 2017

Available in print through MWHC library: 2002 - present

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).


English

1878-0938


*Cardiovascular Agents/ad [Administration & Dosage]
*Coronary Angiography
*Coronary Artery Disease/th [Therapy]
*Coronary Vessels/dg [Diagnostic Imaging]
*Drug-Eluting Stents
*Percutaneous Coronary Intervention/is [Instrumentation]
*Sirolimus/aa [Analogs & Derivatives]
Aged
Cardiovascular Agents/ae [Adverse Effects]
Coronary Artery Disease/dg [Diagnostic Imaging]
Coronary Artery Disease/mo [Mortality]
Coronary Restenosis/dg [Diagnostic Imaging]
Coronary Restenosis/et [Etiology]
Coronary Restenosis/pc [Prevention & Control]
Drug Administration Schedule
Drug Therapy, Combination
Feasibility Studies
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention/ae [Adverse Effects]
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]
Time Factors
Treatment Outcome
Ultrasonography, Interventional
United States


MedStar Health Research Institute
MedStar Heart & Vascular Institute
MedStar Southern Maryland Hospital Center
MedStar Union Memorial Hospital


Journal Article

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