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Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.
- Source :
-
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2019 Jun 01; Vol. 93 (7), pp. 1255-1261. Date of Electronic Publication: 2018 Nov 29. - Publication Year :
- 2019
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Abstract
- 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.<br />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.<br />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.<br />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 <subscript>non-inferiority</subscript> = 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).<br />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.<br /> (© 2018 Wiley Periodicals, Inc.)
- Subjects :
- Aged
Coronary Angiography
Coronary Artery Disease diagnostic imaging
Coronary Artery Disease mortality
Coronary Restenosis etiology
Equivalence Trials as Topic
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention mortality
Prosthesis Design
Risk Factors
Time Factors
Treatment Outcome
Coronary Artery Disease therapy
Percutaneous Coronary Intervention instrumentation
Stents
Subjects
Details
- Language :
- English
- ISSN :
- 1522-726X
- Volume :
- 93
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 30489011
- Full Text :
- https://doi.org/10.1002/ccd.27952