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Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study
Author(s) -
Généreux Philippe,
Kini Annapoorna,
Lesiak Maciej,
Kumsars Indulis,
Fontos Géza,
Slagboom Ton,
Ungi Imre,
Metzger D. Christopher,
Wykrzykowska Joanna J.,
Stella Pieter R.,
Bartorelli Antonio L.,
Fearon William F.,
Lefèvre Thierry,
Feldman Robert L.,
Tarantini Giuseppe,
Bettinger Nicolas,
Minalu Ayele Girma,
LaSalle Laura,
Francese Dominic P.,
Onuma Yoshinobu,
Grundeken Maik J.,
GarciaGarcia Hector M.,
Laak Linda L.,
Cutlip Donald E.,
Kaplan Aaron V.,
Serruys Patrick W.,
Leon Martin B.
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26240
Subject(s) - medicine , clinical endpoint , stent , randomized controlled trial , revascularization , stenosis , nuclear medicine , cardiology , surgery , radiology , myocardial infarction
Objectives 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.