title: Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial.
abstract: BACKGROUND
  Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer.
  
  
  METHODS
  This open-label, prospective, randomised, controlled, non-inferiority trial was undertaken at 12 sites across Europe. We used limited exclusion criteria (age >18 years, life expectancy >5 years, reference vessel diameter 2·0-4·0 mm) to enrol patients eligible for percutaneous coronary intervention. Patients were randomly allocated (2:1) by computer-generated random numbers to receive either a biodegradable polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA, USA). The primary endpoint was a composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (clinically indicated target vessel revascularisation) at 12 months, analysed by intention to treat. Patients received dual antiplatelet therapy for 12 months after discharge. The trial is registered with ClinicalTrials.gov, number NCT01233453.
  
  
  RESULTS
  From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients (4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99·3%) patients completed 12 months' follow-up. Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5·9%] vs 19 [2·1%]; p<0·0001). The primary endpoint occurred in 93 (5·2%) patients in the biolimus-eluting stent group and 44 (4·8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1·07 [95% CI 0·75-1·52]; p(non-inferiority)<0·0001). Analysis per protocol did not change the outcome of this trial (p(non-inferiority)<0·0001).
  
  
  CONCLUSIONS
  Biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. We need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent.
  
  
  BACKGROUND
  Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands).
authors: Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, Netherlands. smitsp@maasstadziekenhuis.nl
authors: Pieter Cornelis
authors: PC
authors: Smits
authors: Sjoerd
authors: S
authors: Hofma
authors: Mario
authors: M
authors: Togni
authors: Nicolás
authors: N
authors: Vázquez
authors: Mariano
authors: M
authors: Valdés
authors: Vassilis
authors: V
authors: Voudris
authors: Ton
authors: T
authors: Slagboom
authors: Jean-Jaques
authors: JJ
authors: Goy
authors: Andre
authors: A
authors: Vuillomenet
authors: Antoni
authors: A
authors: Serra
authors: Ramiro Trillo
authors: RT
authors: Nouche
authors: Peter
authors: P
authors: den Heijer
authors: Martin
authors: M
authors: van der Ent
mesh_terms: D020341:Absorbable Implants; D001241:Aspirin / Q000627:therapeutic use; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D000068338:Everolimus; D001241:Aspirin; C518022:umirolimus; D020123:Sirolimus