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(Circulation. 2006;114:1955-1961.)
© 2006 American Heart Association, Inc.

Interventional Cardiology

Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions

The Nordic Bifurcation Study

Terje K. Steigen, MD; Michael Maeng, MD; Rune Wiseth, MD; Andrejs Erglis, MD; Indulis Kumsars, MD; Inga Narbute, MD; Pål Gunnes, MD; Jan Mannsverk, MD; Oliver Meyerdierks, MD; Svein Rotevatn, MD; Matti Niemelä, MD; Kari Kervinen, MD; Jan S. Jensen, MD; Anders Galløe, MD; Kjell Nikus, MD; Saila Vikman, MD; Jan Ravkilde, MD; Stefan James, MD; Jens Aarøe, MD; Antti Ylitalo, MD; Steffen Helqvist, MD; Iwar Sjögren, MD; Per Thayssen, MD; Kari Virtanen, MD; Mikko Puhakka, MD; Juhani Airaksinen, MD; Jens F. Lassen, MD; Leif Thuesen, MD, for the Nordic PCI Study Group

From the Department of Cardiology, University Hospital of Tromsoe (T.K.S., J.M.), Tromsoe, Norway; Department of Cardiology, Skejby Sygehus, Aarhus University Hospital (M.M., J.R., J.F.L., L.T.), Aarhus, Denmark; Department of Cardiology, St. Olav Hospital (R.W.), Trondheim, Norway; Department of Cardiology, Paul Stradins Clinical Hospital (A.E., I.K., I.N.), Riga, Latvia; Feiring Heart Clinic (P.G.), Feiring, Norway; Department of Cardiology, Ullevaal University Hospital (O.M.), Oslo, Norway; Department of Cardiology, Haukeland University Hospital (S.R.), Bergen, Norway; Division of Cardiology, Department of Internal Medicine, University of Oulu (M.N., K.K.), Oulu, Finland; Department of Cardiology, Gentofte University Hospital (J.S.J., A.G.), Gentofte, Denmark; Department of Cardiology, Tampere University Hospital (K.N., S.V.), Tampere, Finland; Department of Cardiology, Uppsala University Hospital (S.J.), Uppsala, Sweden; Department of Cardiology, Aalborg University Hospital (J. Aarøe), Aalborg, Denmark; Department of Cardiology, Satakunta Central Hospital (A.Y.), Pori, Finland; Department of Cardiology, Rigshospitalet (S.H.), Copenhagen, Denmark; Department of Cardiology, Falun Hospital (I.S.), Falun, Sweden; Department of Cardiology, Odense University Hospital (P.T.), Odense, Denmark; Division of Cardiology, Helsinki University Central Hospital (K.V.), Helsinki, Finland; Division of Cardiology, Kuopio University Central Hospital (M.P.), Kuopio, Finland; and Division of Cardiology, Turku University Central Hospital (J. Airaksinen), Turku, Finland.

Correspondence to Leif Thuesen, Department of Cardiology, Skejby Sygehus, Aarhus University Hospital, 8200 Aarhus N, Denmark. E-mail leif.thuesen{at}ki.au.dk

Received September 15, 2006; revision received September 28, 2006; accepted October 3, 2006.

Background— The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents.

Methods and Results— A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS).

Conclusions— Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.

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