Document Detail


Six-month and one-year clinical outcomes after placement of a dedicated coronary bifurcation stent: a patient-level pooled analysis of eight registry studies.
MedLine Citation:
PMID:  23360690     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Aims: Smaller studies have previously shown promising results after Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA) placement. However, these previous studies were limited by their small sample size and relatively short follow-up. We performed a patient-level pooled analysis to evaluate six-month and one 91year clinical outcomes of more than 900 patients who were enrolled in eight registries with the Tryton stent. Methods and results: Data from eight Tryton registries, including 905 patients with 929 bifurcation lesions, were pooled on a patient level to form one dataset. The primary outcome was six-month target vessel failure (TVF), defined as the composite of cardiac death, any myocardial infarction, and clinically indicated target vessel revascularisation. Procedural success was defined as successful stent placement and no in-hospital major adverse cardiac events. Multivariable analysis was performed to determine independent predictors for one-year TVF. Follow-up data were available in 97%. Procedural success was 95% and TVF rate was 6.5% at six months and 8.5% at one year. Stent thrombosis occurred in 0.5% of patients. Left main coronary artery bifurcation lesion (HR 6.46) and main branch reference vessel diameter <3.0 mm (HR 2.62) were independent predictors for TVF. Conclusions: In the real world setting of registries including more than 900 patients, the use of the Tryton stent is associated with procedural and mid-term clinical results that compare very favourably with historical studies. The primary endpoint of TVF was primarily determined by reference vessel diameter of the main branch and left main bifurcation lesion location.
Authors:
Maik J Grundeken; Solomon Asgedom; Peter Damman; Maciej Lesiak; Michael S Norell; Eulogio Garcia; Armando Bethencourt; Pier Woudstra; Karel T Koch; Marije M Vis; Jose P S Henriques; Yoshinobu Onuma; David P Foley; Antonio L Bartorelli; Pieter R Stella; Jan G P Tijssen; Robbert J de Winter; Joanna J Wykrzykowska
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-30
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  -     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-30     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Cardiology, Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands.
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