Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis

Maayan Konigstein, Iva Srdanovic, Ankita K. Gore, Hussein M. Rahim, Philippe Genereux, Ori Ben-Yehuda, Indulis Kumsars, Maciej Lesiak, Annapoorna Kini, Géza Fontos, Ton Slagboom, Imre Ungi, D. Christopher Metzger, Aaron Crowley, Martin B. Leon, Ziad A. Ali

Research output: Contribution to journalArticle

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. 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 (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). 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.

Original languageEnglish (US)
Pages (from-to)1255-1261
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume93
Issue number7
DOIs
StatePublished - Jun 1 2019

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Stents
Pathologic Constriction
Therapeutics
Group Processes
Randomized Controlled Trials
Safety

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Konigstein, Maayan ; Srdanovic, Iva ; Gore, Ankita K. ; Rahim, Hussein M. ; Genereux, Philippe ; Ben-Yehuda, Ori ; Kumsars, Indulis ; Lesiak, Maciej ; Kini, Annapoorna ; Fontos, Géza ; Slagboom, Ton ; Ungi, Imre ; Christopher Metzger, D. ; Crowley, Aaron ; Leon, Martin B. ; Ali, Ziad A. / Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations : Individual-patient-data pooled analysis. In: Catheterization and Cardiovascular Interventions. 2019 ; Vol. 93, No. 7. pp. 1255-1261.
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title = "Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis",
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. 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 (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). 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.",
author = "Maayan Konigstein and Iva Srdanovic and Gore, {Ankita K.} and Rahim, {Hussein M.} and Philippe Genereux and Ori Ben-Yehuda and Indulis Kumsars and Maciej Lesiak and Annapoorna Kini and G{\'e}za Fontos and Ton Slagboom and Imre Ungi and {Christopher Metzger}, D. and Aaron Crowley and Leon, {Martin B.} and Ali, {Ziad A.}",
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Konigstein, M, Srdanovic, I, Gore, AK, Rahim, HM, Genereux, P, Ben-Yehuda, O, Kumsars, I, Lesiak, M, Kini, A, Fontos, G, Slagboom, T, Ungi, I, Christopher Metzger, D, Crowley, A, Leon, MB & Ali, ZA 2019, 'Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis', Catheterization and Cardiovascular Interventions, vol. 93, no. 7, pp. 1255-1261. https://doi.org/10.1002/ccd.27952

Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations : Individual-patient-data pooled analysis. / Konigstein, Maayan; Srdanovic, Iva; Gore, Ankita K.; Rahim, Hussein M.; Genereux, Philippe; Ben-Yehuda, Ori; Kumsars, Indulis; Lesiak, Maciej; Kini, Annapoorna; Fontos, Géza; Slagboom, Ton; Ungi, Imre; Christopher Metzger, D.; Crowley, Aaron; Leon, Martin B.; Ali, Ziad A.

In: Catheterization and Cardiovascular Interventions, Vol. 93, No. 7, 01.06.2019, p. 1255-1261.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations

T2 - Individual-patient-data pooled analysis

AU - Konigstein, Maayan

AU - Srdanovic, Iva

AU - Gore, Ankita K.

AU - Rahim, Hussein M.

AU - Genereux, Philippe

AU - Ben-Yehuda, Ori

AU - Kumsars, Indulis

AU - Lesiak, Maciej

AU - Kini, Annapoorna

AU - Fontos, Géza

AU - Slagboom, Ton

AU - Ungi, Imre

AU - Christopher Metzger, D.

AU - Crowley, Aaron

AU - Leon, Martin B.

AU - Ali, Ziad A.

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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 (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). 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.

AB - 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 (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). 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.

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DO - 10.1002/ccd.27952

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