title: Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions: 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions.
  
  
  BACKGROUND
  The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland).
  
  
  METHODS
  A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany.
  
  
  RESULTS
  Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported.
  
  
  CONCLUSIONS
  The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119).
authors.affiliation: Institute Dante Pazzanese of Cardiology, São Paulo, Brazil; Cardiovascular Research Center, São Paulo, Brazil. Electronic address: rcosta@dantepazzanese.org.br.
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.affiliation: Institute Dante Pazzanese of Cardiology, São Paulo, Brazil; Cardiovascular Research Center, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.affiliation: Herzzentrum Leipzig GmbH, Leipzig, Germany.
authors.forename: Gerhard C
authors.initials: GC
authors.lastname: Schuler
authors.affiliation: Krankenhaus der Barmherzigen Brüder, Trier, Germany.
authors.forename: Karl E
authors.initials: KE
authors.lastname: Hauptmann
authors.affiliation: Cardiovascular Research Center, São Paulo, Brazil.
authors.forename: Marco A
authors.initials: MA
authors.lastname: Magalhães
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.affiliation: University of Bonn, Bonn, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects*; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058426:Neointima; D017239:Paclitaxel / Q000008:administration & dosage; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013193:Stainless Steel; D013499:Surface Properties; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D013193:Stainless Steel; D017239:Paclitaxel; C518022:umirolimus; D020123:Sirolimus
keywords: biolimus; carrier-free; coronary artery disease; drug-coated stent(s); percutaneous coronary intervention; polymer-free