A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions

Philippe Genereux, Indulis Kumsars, Maciej Lesiak, Annapoorna Kini, Géza Fontos, Ton Slagboom, Imre Ungi, D. Christopher Metzger, Joanna J. Wykrzykowska, Pieter R. Stella, Antonio L. Bartorelli, William F. Fearon, Thierry Lefèvre, Robert L. Feldman, Laura Lasalle, Dominic P. Francese, Yoshinobu Onuma, Maik J. Grundeken, Hector M. Garcia-Garcia, Linda L. LaakDonald E. Cutlip, Aaron V. Kaplan, Patrick W. Serruys, Martin B. Leon

Research output: Contribution to journalArticle

71 Citations (Scopus)

Abstract

Background Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). Objectives The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. Methods We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. Results We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p = 0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis ≥50%) at 9 months follow-up (22.6% vs. 26.8%, p = 0.44). Conclusions Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

Original languageEnglish (US)
Pages (from-to)533-543
Number of pages11
JournalJournal of the American College of Cardiology
Volume65
Issue number6
DOIs
StatePublished - Feb 17 2015
Externally publishedYes

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Stents
Pathologic Constriction
Therapeutics
Myocardial Infarction
Confidence Intervals
Safety
Balloon Angioplasty
Percutaneous Coronary Intervention
Coronary Disease

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Genereux, Philippe ; Kumsars, Indulis ; Lesiak, Maciej ; Kini, Annapoorna ; Fontos, Géza ; Slagboom, Ton ; Ungi, Imre ; Metzger, D. Christopher ; Wykrzykowska, Joanna J. ; Stella, Pieter R. ; Bartorelli, Antonio L. ; Fearon, William F. ; Lefèvre, Thierry ; Feldman, Robert L. ; Lasalle, Laura ; Francese, Dominic P. ; Onuma, Yoshinobu ; Grundeken, Maik J. ; Garcia-Garcia, Hector M. ; Laak, Linda L. ; Cutlip, Donald E. ; Kaplan, Aaron V. ; Serruys, Patrick W. ; Leon, Martin B. / A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. In: Journal of the American College of Cardiology. 2015 ; Vol. 65, No. 6. pp. 533-543.
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title = "A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions",
abstract = "Background Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). Objectives The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. Methods We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. Results We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4{\%} in the bifurcation stent group compared with 12.8{\%} in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6{\%} vs. 10.1{\%}, p = 0.19). The TVF difference of +4.6{\%} (2-sided 95{\%} confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95{\%} confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5{\%} (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6{\%} vs. 38.6{\%}, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis ≥50{\%}) at 9 months follow-up (22.6{\%} vs. 26.8{\%}, p = 0.44). Conclusions Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)",
author = "Philippe Genereux and Indulis Kumsars and Maciej Lesiak and Annapoorna Kini and G{\'e}za Fontos and Ton Slagboom and Imre Ungi and Metzger, {D. Christopher} and Wykrzykowska, {Joanna J.} and Stella, {Pieter R.} and Bartorelli, {Antonio L.} and Fearon, {William F.} and Thierry Lef{\`e}vre and Feldman, {Robert L.} and Laura Lasalle and Francese, {Dominic P.} and Yoshinobu Onuma and Grundeken, {Maik J.} and Garcia-Garcia, {Hector M.} and Laak, {Linda L.} and Cutlip, {Donald E.} and Kaplan, {Aaron V.} and Serruys, {Patrick W.} and Leon, {Martin B.}",
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Genereux, P, Kumsars, I, Lesiak, M, Kini, A, Fontos, G, Slagboom, T, Ungi, I, Metzger, DC, Wykrzykowska, JJ, Stella, PR, Bartorelli, AL, Fearon, WF, Lefèvre, T, Feldman, RL, Lasalle, L, Francese, DP, Onuma, Y, Grundeken, MJ, Garcia-Garcia, HM, Laak, LL, Cutlip, DE, Kaplan, AV, Serruys, PW & Leon, MB 2015, 'A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions', Journal of the American College of Cardiology, vol. 65, no. 6, pp. 533-543. https://doi.org/10.1016/j.jacc.2014.11.031

A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. / Genereux, Philippe; Kumsars, Indulis; Lesiak, Maciej; Kini, Annapoorna; Fontos, Géza; Slagboom, Ton; Ungi, Imre; Metzger, D. Christopher; Wykrzykowska, Joanna J.; Stella, Pieter R.; Bartorelli, Antonio L.; Fearon, William F.; Lefèvre, Thierry; Feldman, Robert L.; Lasalle, Laura; Francese, Dominic P.; Onuma, Yoshinobu; Grundeken, Maik J.; Garcia-Garcia, Hector M.; Laak, Linda L.; Cutlip, Donald E.; Kaplan, Aaron V.; Serruys, Patrick W.; Leon, Martin B.

In: Journal of the American College of Cardiology, Vol. 65, No. 6, 17.02.2015, p. 533-543.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions

AU - Genereux, Philippe

AU - Kumsars, Indulis

AU - Lesiak, Maciej

AU - Kini, Annapoorna

AU - Fontos, Géza

AU - Slagboom, Ton

AU - Ungi, Imre

AU - Metzger, D. Christopher

AU - Wykrzykowska, Joanna J.

AU - Stella, Pieter R.

AU - Bartorelli, Antonio L.

AU - Fearon, William F.

AU - Lefèvre, Thierry

AU - Feldman, Robert L.

AU - Lasalle, Laura

AU - Francese, Dominic P.

AU - Onuma, Yoshinobu

AU - Grundeken, Maik J.

AU - Garcia-Garcia, Hector M.

AU - Laak, Linda L.

AU - Cutlip, Donald E.

AU - Kaplan, Aaron V.

AU - Serruys, Patrick W.

AU - Leon, Martin B.

PY - 2015/2/17

Y1 - 2015/2/17

N2 - Background Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). Objectives The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. Methods We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. Results We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p = 0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis ≥50%) at 9 months follow-up (22.6% vs. 26.8%, p = 0.44). Conclusions Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

AB - Background Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB). Objectives The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty. Methods We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent. The primary endpoint (powered for noninferiority) was target vessel failure (TVF) (cardiac death, target vessel myocardial infarction, and target vessel revascularization). The secondary angiographic endpoint (powered for superiority) was in-segment percent diameter stenosis of the SB at 9 months. Results We randomized 704 patients with bifurcation coronary lesions at 58 centers (30 from Europe and 28 from the United States). At 9 months, TVF was 17.4% in the bifurcation stent group compared with 12.8% in the provisional group (p = 0.11), mainly because of a higher periprocedural myocardial infarction rate (13.6% vs. 10.1%, p = 0.19). The TVF difference of +4.6% (2-sided 95% confidence interval: -1.0 to 10.3; upper limit of the 1-sided 95% confidence interval: 10.3) was not within the pre-specified noninferiority margin of 5.5% (p = 0.42 for noninferiority). The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group (31.6% vs. 38.6%, p = 0.002 for superiority), with no difference in binary restenosis rates (diameter stenosis ≥50%) at 9 months follow-up (22.6% vs. 26.8%, p = 0.44). Conclusions Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions. (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

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