title: Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study.
abstract: BACKGROUND
  Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device.
  
  
  OBJECTIVE
  To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions.
  
  
  METHODS
  The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score <32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433).
  
  
  RESULTS
  Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred.
  
  
  CONCLUSIONS
  This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.
authors.affiliation: Cardiology Clinic, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy. Electronic address: giuseppe.tarantini.1@gmail.com.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.forename: Luigi
authors.initials: L
authors.lastname: La Vecchia
authors.forename: Mario
authors.initials: M
authors.lastname: Galli
authors.forename: Luca
authors.initials: L
authors.lastname: Favero
authors.forename: Gianpiero
authors.initials: G
authors.lastname: D'Amico
authors.forename: Paolo
authors.initials: P
authors.lastname: Buja
authors.forename: Filippo
authors.initials: F
authors.lastname: Russo
authors.forename: Ester
authors.initials: E
authors.lastname: Cabianca
authors.forename: Massimo
authors.initials: M
authors.lastname: Napodano
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Musumeci
authors.forename: Enrico
authors.initials: E
authors.lastname: Franceschini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Grassi
authors.forename: Andrea
authors.initials: A
authors.lastname: Pavei
authors.forename: Roberto
authors.initials: R
authors.lastname: Bonmassari
authors.forename: Carlo
authors.initials: C
authors.lastname: Cernetti
authors.forename: Leonardo
authors.initials: L
authors.lastname: Spedicato
authors.forename: Francesco
authors.initials: F
authors.lastname: Caprioglio
authors.forename: Bernhard
authors.initials: B
authors.lastname: Reimers
authors.forename: Giambattista
authors.initials: G
authors.lastname: Isabella
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000706:statistics & numerical data; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology; D003328:Coronary Thrombosis / Q000453:epidemiology; D003331:Coronary Vessels / Q000473:pathology; D054855:Drug-Eluting Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data; D015607:Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D016896:Treatment Outcome
keywords: Bifurcation lesions; Coronary artery disease; Dedicated bifurcation device; Percutaneous coronary intervention