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

Matti Niemelä, Kari Kervinen, Andrejs Erglis, Niels Ramsing Holm, Michael Maeng, Evald Høj Christiansen, Indulis Kumsars, Sanda Jegere, Andis Dombrovskis, Pål Gunnes, Sindre Stavnes, Terje K Steigen, Thor Trovik, Markku Eskola, Saila Vikman, Hannu Romppanen, Timo Mäkikallio, Knud Nørregaard Hansen, Per Thayssen, Lars AbergeLisette Okkels Jensen, Anders Hervold, Juhani Airaksinen, Mikko Pietilä, Ole Frobert, Thomas Kellerth, Jan Ravkilde, Jens Aarøe, Jan S Jensen, Steffen Helqvist, Iwar Sjögren, Stefan James, Heikki Miettinen, Jens Flensted Lassen, Leif Thuesen, Nordic-Baltic PCI Study Group

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    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.
    METHODS AND 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.
    OriginalsprogEngelsk
    TidsskriftCirculation
    Vol/bind123
    Udgave nummer1
    Sider (fra-til)79-86
    Antal sider8
    ISSN0009-7322
    DOI
    StatusUdgivet - 4 jan. 2011

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