title: Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial.
abstract: BACKGROUND
  Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Polish Bifurcation Optimal Stenting I (POLBOS I) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes.
  
  
  METHODS
  Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSS Expert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months.
  
  
  RESULTS
  The BiOSS Expert was implanted in 120 patients (49.4%), and an rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P = 0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert (8.1% vs 13.2%; P < 0.05) and rDES groups (4.9% vs 9.5%; P < 0.05).
  
  
  CONCLUSIONS
  MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes.
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland. Electronic address: scorpirg@gmail.com.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gil
authors.affiliation: Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Bil
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
authors.forename: Vladimír
authors.initials: V
authors.lastname: Džavík
authors.affiliation: Alexandrovska University Hospital, Sofia, Bulgaria.
authors.forename: Dobrin
authors.initials: D
authors.lastname: Vassilev
authors.affiliation: Faculty of Medical Sciences, University of Varmia and Masuria, Olsztyn, Poland.
authors.forename: Adam
authors.initials: A
authors.lastname: Kern
authors.affiliation: 10th Clinical Military Hospital, Bydgoszcz, Poland.
authors.forename: Radoslaw
authors.initials: R
authors.lastname: Formuszewicz
authors.affiliation: Department of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Zalewska-Adamiec
authors.affiliation: Department of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland.
authors.forename: Sławomir
authors.initials: S
authors.lastname: Dobrzycki
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011474:Prosthesis Design; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome