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

Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):475-481. doi: 10.1016/j.carrev.2017.07.017. Epub 2017 Jul 31.

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.

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).

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.

Keywords: Biolimus A9; Drug-coated stent; Late lumen loss; Polymer-free drug-eluting stent.

Publication types

  • Controlled Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coronary Angiography*
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / etiology
  • Coronary Restenosis / prevention & control
  • Coronary Vessels / diagnostic imaging*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Drug-Eluting Stents*
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Platelet Aggregation Inhibitors / administration & dosage
  • Predictive Value of Tests
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Sirolimus / administration & dosage
  • Sirolimus / adverse effects
  • Sirolimus / analogs & derivatives*
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Interventional
  • United States

Substances

  • Cardiovascular Agents
  • Platelet Aggregation Inhibitors
  • umirolimus
  • Sirolimus