title: Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial.
abstract: OBJECTIVE
  The aim of the POLBOS II randomised trial was to compare any regular drug-eluting stents (rDES) with the dedicated bifurcation sirolimus-eluting stent BiOSS LIM for the treatment of coronary bifurcation lesions. The secondary aim was to study the effect of final kissing balloon inflation (FKBI) on clinical outcomes.
  
  
  RESULTS
  Between December 2012 and December 2013, 202 patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with an rDES (n=100). Coronary re-angiography was performed at 12 months. The primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target lesion revascularisation (TLR) at 12 months. The target vessel was located in the left main in one third of the cases (35.3% in BiOSS and 38% in rDES). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p<0.05).
  
  
  CONCLUSIONS
  MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gil
authors.forename: Jacek
authors.initials: J
authors.lastname: Bil
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.forename: Adam
authors.initials: A
authors.lastname: Kern
authors.forename: Luis A
authors.initials: LA
authors.lastname: Iñigo Garcia
authors.forename: Dobrin
authors.initials: D
authors.lastname: Vassilev
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pawłowski
authors.forename: Radoslaw
authors.initials: R
authors.lastname: Formuszewicz
authors.forename: Sławomir
authors.initials: S
authors.lastname: Dobrzycki
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000628:therapy; D000328:Adult; D000368:Aged; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000628:therapy; D023921:Coronary Stenosis / Q000188:drug therapy* / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus