Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study

Philippe Généreux, Indulis Kumsars, Joel E. Schneider, Maciej Lesiak, Björn Redfors, Kristoff Cornelis, Matthew R. Selmon, Jo Dens, Angela Hoye, D. Christopher Metzger, Luc Muyldermans, Ton Slagboom, Dominic P. Francese, Girma Minalu Ayele, Linda L. Laak, Antonio L. Bartorelli, Donald E. Cutlip, Aaron V. Kaplan, Martin B. Leon

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. Methods The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. Results Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint. Conclusions The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

Original languageEnglish (US)
Pages (from-to)1338-1346
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume9
Issue number13
DOIs
StatePublished - Jul 11 2016
Externally publishedYes

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Stents
Randomized Controlled Trials
Myocardial Infarction
Therapeutics
Safety
MB Form Creatine Kinase
Coronary Angiography
Population
Coronary Vessels

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Généreux, Philippe ; Kumsars, Indulis ; Schneider, Joel E. ; Lesiak, Maciej ; Redfors, Björn ; Cornelis, Kristoff ; Selmon, Matthew R. ; Dens, Jo ; Hoye, Angela ; Metzger, D. Christopher ; Muyldermans, Luc ; Slagboom, Ton ; Francese, Dominic P. ; Ayele, Girma Minalu ; Laak, Linda L. ; Bartorelli, Antonio L. ; Cutlip, Donald E. ; Kaplan, Aaron V. ; Leon, Martin B. / Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches : Outcomes From the Tryton Confirmatory Study. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 13. pp. 1338-1346.
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abstract = "Objectives The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. Methods The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. Results Among the 133 enrolled patients, 132 (99.2{\%}) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5{\%} of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9{\%}). The 95{\%} confidence bounds did not extend beyond the pre-defined performance goal of 17.9{\%}, meeting the noninferiority primary endpoint. Conclusions The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.",
author = "Philippe G{\'e}n{\'e}reux and Indulis Kumsars and Schneider, {Joel E.} and Maciej Lesiak and Bj{\"o}rn Redfors and Kristoff Cornelis and Selmon, {Matthew R.} and Jo Dens and Angela Hoye and Metzger, {D. Christopher} and Luc Muyldermans and Ton Slagboom and Francese, {Dominic P.} and Ayele, {Girma Minalu} and Laak, {Linda L.} and Bartorelli, {Antonio L.} and Cutlip, {Donald E.} and Kaplan, {Aaron V.} and Leon, {Martin B.}",
year = "2016",
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language = "English (US)",
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pages = "1338--1346",
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Généreux, P, Kumsars, I, Schneider, JE, Lesiak, M, Redfors, B, Cornelis, K, Selmon, MR, Dens, J, Hoye, A, Metzger, DC, Muyldermans, L, Slagboom, T, Francese, DP, Ayele, GM, Laak, LL, Bartorelli, AL, Cutlip, DE, Kaplan, AV & Leon, MB 2016, 'Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study', JACC: Cardiovascular Interventions, vol. 9, no. 13, pp. 1338-1346. https://doi.org/10.1016/j.jcin.2016.03.042

Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches : Outcomes From the Tryton Confirmatory Study. / Généreux, Philippe; Kumsars, Indulis; Schneider, Joel E.; Lesiak, Maciej; Redfors, Björn; Cornelis, Kristoff; Selmon, Matthew R.; Dens, Jo; Hoye, Angela; Metzger, D. Christopher; Muyldermans, Luc; Slagboom, Ton; Francese, Dominic P.; Ayele, Girma Minalu; Laak, Linda L.; Bartorelli, Antonio L.; Cutlip, Donald E.; Kaplan, Aaron V.; Leon, Martin B.

In: JACC: Cardiovascular Interventions, Vol. 9, No. 13, 11.07.2016, p. 1338-1346.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches

T2 - Outcomes From the Tryton Confirmatory Study

AU - Généreux, Philippe

AU - Kumsars, Indulis

AU - Schneider, Joel E.

AU - Lesiak, Maciej

AU - Redfors, Björn

AU - Cornelis, Kristoff

AU - Selmon, Matthew R.

AU - Dens, Jo

AU - Hoye, Angela

AU - Metzger, D. Christopher

AU - Muyldermans, Luc

AU - Slagboom, Ton

AU - Francese, Dominic P.

AU - Ayele, Girma Minalu

AU - Laak, Linda L.

AU - Bartorelli, Antonio L.

AU - Cutlip, Donald E.

AU - Kaplan, Aaron V.

AU - Leon, Martin B.

PY - 2016/7/11

Y1 - 2016/7/11

N2 - Objectives The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. Methods The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. Results Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint. Conclusions The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

AB - Objectives The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. Methods The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. Results Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint. Conclusions The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

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