title: Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III.
abstract: BACKGROUND
  It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD.
  
  
  RESULTS
  We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively.
  
  
  CONCLUSIONS
  MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, University of Oulu, Finland. matti.niemela@ppshp.fi
authors.forename: Matti
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authors.lastname: Niemelä
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authors.forename: Sindre
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authors.lastname: Stavnes
authors.forename: Terje K
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authors.forename: Hannu
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authors.lastname: Romppanen
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authors.forename: Knud N
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authors.lastname: Hansen
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authors.lastname: Thayssen
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authors.forename: Lisette O
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authors.lastname: Hervold
authors.forename: Juhani
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authors.lastname: Airaksinen
authors.forename: Mikko
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authors.lastname: Pietilä
authors.forename: Ole
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authors.lastname: Frobert
authors.forename: Thomas
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authors.lastname: Kellerth
authors.forename: Jan
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authors.lastname: Ravkilde
authors.forename: Jens
authors.initials: J
authors.lastname: Aarøe
authors.forename: Jan S
authors.initials: JS
authors.lastname: Jensen
authors.forename: Steffen
authors.initials: S
authors.lastname: Helqvist
authors.forename: Iwar
authors.initials: I
authors.lastname: Sjögren
authors.forename: Stefan
authors.initials: S
authors.lastname: James
authors.forename: Heikki
authors.initials: H
authors.lastname: Miettinen
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000473:pathology* / Q000628:therapy*; D003718:Denmark / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005260:Female; D005387:Finland / Q000453:epidemiology; D005500:Follow-Up Studies; D006801:Humans; D007844:Latvia / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009664:Norway / Q000453:epidemiology; D013548:Sweden / Q000453:epidemiology