title: Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.
abstract: OBJECTIVE
  To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs.
  
  
  BACKGROUND
  The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs).
  
  
  METHODS
  The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA.
  
  
  RESULTS
  Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004).
  
  
  CONCLUSIONS
  Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.
authors.affiliation: Columbia University Medical Center/NewYork Presbyterian Hospital, New York, New York.|Cardiovascular Research Foundation, New York, New York.|Hôpital Du Sacré-Coeur De Montréal, Université De Montréal, Montréal, Québec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: Mount Sinai Medical Center, New York, New York.
authors.forename: Annapoorna
authors.initials: A
authors.lastname: Kini
authors.affiliation: 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Lesiak
authors.affiliation: Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Indulis
authors.initials: I
authors.lastname: Kumsars
authors.affiliation: Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary.
authors.forename: Géza
authors.initials: G
authors.lastname: Fontos
authors.affiliation: Department of Cardiology, OLVG, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.affiliation: 2nd Department of Medicine and Cardiology Center Medical Faculty, Albert Szent-Györgyi Clinical Center, University of Szeged- Department of Cardiology, Szeged, Hungary.
authors.forename: Imre
authors.initials: I
authors.lastname: Ungi
authors.affiliation: Wellmont CVA Heart Institute, Kingsport, Tennessee.
authors.forename: D Christopher
authors.initials: DC
authors.lastname: Metzger
authors.affiliation: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.affiliation: Department of Interventional Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
authors.affiliation: Centro Cardiologico Monzino, University of Milan, Milan, Italy.
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Bartorelli
authors.affiliation: Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California.
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
authors.affiliation: Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: MediQuest Research Group, Ocala, Florida.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Feldman
authors.affiliation: Azienda Ospedaliera Di Padova, Padova, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: Columbia University Medical Center/NewYork Presbyterian Hospital, New York, New York.|Cardiovascular Research Foundation, New York, New York.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Bettinger
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Girma
authors.initials: G
authors.lastname: Minalu Ayele
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Laura
authors.initials: L
authors.lastname: LaSalle
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Dominic P
authors.initials: DP
authors.lastname: Francese
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Tryton Medical Inc., Durham, North Carolina.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Laak
authors.affiliation: Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: Tryton Medical Inc., Durham, North Carolina.|Dartmouth-Hitchcock Medical Center, New Hampshire, Lebanon.
authors.forename: Aaron V
authors.initials: AV
authors.lastname: Kaplan
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Columbia University Medical Center/NewYork Presbyterian Hospital, New York, New York.|Cardiovascular Research Foundation, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D016037:Single-Blind Method; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
keywords: PCI; coronary bifurcation; coronary stent