title: A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions.
abstract: BACKGROUND
  Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB).
  
  
  OBJECTIVE
  The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty.
  
  
  METHODS
  We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months.
  
  
  RESULTS
  We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p=0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p=0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p=0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p=0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis≥50%) at 9 months follow-up (22.6% vs. 26.8%, p=0.44).
  
  
  CONCLUSIONS
  Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972).
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
authors: Philippe
authors: P
authors: Généreux
authors: Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.
authors: Indulis
authors: I
authors: Kumsars
authors: 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.
authors: Maciej
authors: M
authors: Lesiak
authors: Mount Sinai Medical Center, New York, New York.
authors: Annapoorna
authors: A
authors: Kini
authors: Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary.
authors: Géza
authors: G
authors: Fontos
authors: Department of Cardiology, OLVG, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
authors: Ton
authors: T
authors: Slagboom
authors: 2nd Department of Medicine and Cardiology Center, Medical Faculty, Albert Szent-Györgyi Clinical Center, University of Szeged, Department of Cardiology, Szeged, Hungary.
authors: Imre
authors: I
authors: Ungi
authors: Wellmont CVA Heart Institute, Kingsport, Tennessee.
authors: D Christopher
authors: DC
authors: Metzger
authors: Department of Cardiology, Amsterdam Medical Center, Amsterdam, the Netherlands.
authors: Joanna J
authors: JJ
authors: Wykrzykowska
authors: University Medical Center Utrecht, Department of Interventional Cardiology, Utrecht, the Netherlands.
authors: Pieter R
authors: PR
authors: Stella
authors: Centro Cardiologico Monzino, University of Milan, Milan, Italy.
authors: Antonio L
authors: AL
authors: Bartorelli
authors: Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California.
authors: William F
authors: WF
authors: Fearon
authors: Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
authors: Thierry
authors: T
authors: Lefèvre
authors: MediQuest Research Group, Ocala, Florida.
authors: Robert L
authors: RL
authors: Feldman
authors: Cardiovascular Research Foundation, New York, New York.
authors: Laura
authors: L
authors: LaSalle
authors: Cardiovascular Research Foundation, New York, New York.
authors: Dominic P
authors: DP
authors: Francese
authors: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Yoshinobu
authors: Y
authors: Onuma
authors: Department of Cardiology, Amsterdam Medical Center, Amsterdam, the Netherlands.
authors: Maik J
authors: MJ
authors: Grundeken
authors: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Hector M
authors: HM
authors: Garcia-Garcia
authors: Tryton Medical Inc., Durham, North Carolina.
authors: Linda L
authors: LL
authors: Laak
authors: Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors: Donald E
authors: DE
authors: Cutlip
authors: Tryton Medical Inc., Durham, North Carolina; Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
authors: Aaron V
authors: AV
authors: Kaplan
authors: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors: Patrick W
authors: PW
authors: Serruys
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: ml2398@columbia.edu.
authors: Martin B
authors: MB
authors: Leon
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D003331:Coronary Vessels / Q000601:surgery*; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: PCI; coronary bifurcation; coronary stent