Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.
angioplasty
bifurcation
drug-eluting stent
percutaneous coronary intervention
provisional
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 06 2019
01 06 2019
Historique:
received:
30
08
2018
revised:
11
09
2018
accepted:
08
10
2018
pubmed:
30
11
2018
medline:
23
6
2020
entrez:
30
11
2018
Statut:
ppublish
Résumé
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 (p 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.
Sections du résumé
OBJECTIVES
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.
BACKGROUND
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.
METHODS
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.
RESULTS
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 (p
CONCLUSIONS
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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1255-1261Informations de copyright
© 2018 Wiley Periodicals, Inc.