Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations

We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs.Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently...

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Bibliographic Details
Main Authors: Konigstein Maayan
Srdanovic Iva
Gore Ankita K
Rahim Hussein M
Généreux Philippe
Ben-Yehuda Ori
Kumsars Indulis
Lesiak Maciej
Kini Annapoorna
Fontos Géza
Slagboom Ton
Ungi Imre
Metzger D. Christopher
Crowley Aaron
Leon Martin B.
Ali Ziad A.
Format: Article
Published: 2019
Series:CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 93 No. 7
Subjects:
doi:10.1002/ccd.27952

mtmt:31361511
Online Access:http://publicatio.bibl.u-szeged.hu/22346
Description
Summary:We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs.Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions.We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year.Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052).In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.
Physical Description:1255-1261
ISSN:1522-1946