title: Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.
abstract: BACKGROUND
  No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention.
  
  
  RESULTS
  A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026).
  
  
  CONCLUSIONS
  Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up.
  
  
  BACKGROUND
  URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.
authors.affiliation: Department of Cardiology, Triemlispital, Zurich, Switzerland.
authors.forename: Rainer
authors.initials: R
authors.lastname: Zbinden
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piccolo
authors.affiliation: Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland.
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.affiliation: Department of Cardiology, University Hospital, Geneva, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.affiliation: Department of Cardiology, Triemlispital, Zurich, Switzerland.
authors.forename: David J
authors.initials: DJ
authors.lastname: Kurz
authors.affiliation: Department of Cardiology, University Hospital, Lausanne, Switzerland.
authors.forename: Olivier
authors.initials: O
authors.lastname: Muller
authors.affiliation: Department of Cardiology, Kantonsspital, Aarau, Switzerland.
authors.forename: André
authors.initials: A
authors.lastname: Vuilliomenet
authors.affiliation: Department of Cardiology, University Hospital, Fribourg.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cook
authors.affiliation: Department of Cardiology, Kantonsspital, St. Gallen, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Weilenmann
authors.affiliation: Department of Cardiology, University Hospital, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.affiliation: Department of Cardiology, Kantonsspital, Luzern, Switzerland.
authors.forename: Peiman
authors.initials: P
authors.lastname: Jamshidi
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Anna
authors.initials: A
authors.lastname: Franzone
authors.affiliation: Department of Cardiology, Triemlispital, Zurich, Switzerland.
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.affiliation: Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland stephan.windecker@insel.ch.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus
keywords: biodegradable polymer; drug‐eluting stent; everolimus‐eluting stent; percutaneous coronary intervention; sirolimus‐eluting stent