TY - JOUR
T1 - 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
AU - Niemelä, Matti
AU - Kervinen, Kari
AU - Erglis, Andrejs
AU - Holm, Niels R
AU - Maeng, Michael
AU - Christiansen, Evald H
AU - Kumsars, Indulis
AU - Jegere, Sanda
AU - Dombrovskis, Andis
AU - Gunnes, Pål
AU - Stavnes, Sindre
AU - Steigen, Terje K
AU - Trovik, Thor
AU - Eskola, Markku
AU - Vikman, Saila
AU - Romppanen, Hannu
AU - Mäkikallio, Timo
AU - Hansen, Knud Nørregaard
AU - Thayssen, Per
AU - Aberge, Lars
AU - Jensen, Lisette Okkels
AU - Hervold, Anders
AU - Airaksinen, Juhani
AU - Pietilä, Mikko
AU - Frobert, Ole
AU - Kellerth, Thomas
AU - Ravkilde, Jan
AU - Aarøe, Jens
AU - Jensen, Jan S
AU - Helqvist, Steffen
AU - Sjögren, Iwar
AU - James, Stefan
AU - Miettinen, Heikki
AU - Lassen, Jens F
AU - Thuesen, Leif
AU - for the Nordic-Baltic PCI Study Group
PY - 2011/1/4
Y1 - 2011/1/4
N2 - 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. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.
AB - 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. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.
U2 - 10.1161/CIRCULATIONAHA.110.966879
DO - 10.1161/CIRCULATIONAHA.110.966879
M3 - Journal article
SN - 0009-7322
VL - 123
SP - 79
EP - 86
JO - Circulation
JF - Circulation
ER -