title: Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study.
abstract: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs).
  
  
  
  The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled.
  
  
  
  The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT.
  
  
  
  Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint.
  
  
  
  The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.
authors.affiliation: Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.affiliation: Latvian Centre of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.
authors.forename: Indulis
authors.initials: I
authors.lastname: Kumsars
authors.affiliation: North Carolina Heart and Vascular, Raleigh, North Carolina.
authors.forename: Joel E
authors.initials: JE
authors.lastname: Schneider
authors.affiliation: Karol Marcinkowski University of Medical Sciences, Pozan, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Lesiak
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Björn
authors.initials: B
authors.lastname: Redfors
authors.affiliation: AZ Maria Middelares, Gent, Belgium.
authors.forename: Kristoff
authors.initials: K
authors.lastname: Cornelis
authors.affiliation: Austin Heart PLLC, Austin, Texas.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Selmon
authors.affiliation: Ziekenhuis Oost-Limburg, Genk, Belgium.
authors.forename: Jo
authors.initials: J
authors.lastname: Dens
authors.affiliation: Castle Hill Hospital, East Yorkshire, United Kingdom.
authors.forename: Angela
authors.initials: A
authors.lastname: Hoye
authors.affiliation: Wellmont CVA Heart Institute, Kingsport, Tennessee.
authors.forename: D Christopher
authors.initials: DC
authors.lastname: Metzger
authors.affiliation: AZ Sint Jan, Bruges, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Muyldermans
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Dominic P
authors.initials: DP
authors.lastname: Francese
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Girma Minalu
authors.initials: GM
authors.lastname: Ayele
authors.affiliation: Tryton Medical, Inc., Durham, North Carolina.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Laak
authors.affiliation: Monzino Hospital, Milan, Italy.
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Bartorelli
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, Lebanon, New Hampshire.
authors.forename: Aaron V
authors.initials: AV
authors.lastname: Kaplan
authors.affiliation: Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: ml2398@columbia.edu.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D015415:Biomarkers / Q000097:blood; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D052279:Creatine Kinase, MB Form / Q000097:blood; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D015415:Biomarkers; D002858:Chromium Alloys; D052279:Creatine Kinase, MB Form
keywords: PCI; Tryton dedicated bifurcation stent; bifurcation; side branch; stent