title: First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry.
abstract: OBJECTIVE
  The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry.
  
  
  BACKGROUND
  The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.
  
  
  METHODS
  This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.
  
  
  RESULTS
  A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm.
  
  
  CONCLUSIONS
  Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.
authors.affiliation: Invasive Cardiology Department, Central Clinical Hospital of the Ministry of Internal Affairs, Warsaw, Poland; Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gil
authors.forename: Jacek
authors.initials: J
authors.lastname: Bil
authors.forename: Dobrin
authors.initials: D
authors.lastname: Vassiliev
authors.forename: Luis A
authors.initials: LA
authors.lastname: Iñigo Garcia
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D000368:Aged; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus
chemical_list: D020123:Sirolimus