Outcomes of a dedicated stent in coronary bifurcations with large side branches

A subanalysis of the randomized TRYTON bifurcation study

Philippe Genereux, Annapoorna Kini, Maciej Lesiak, Indulis Kumsars, 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, Giuseppe Tarantini, Nicolas Bettinger, Girma Minalu Ayele, Laura LaSalle, Dominic P. Francese, Yoshinobu Onuma & 7 others Maik J. Grundeken, Hector M. Garcia-Garcia, Linda L. Laak, Donald E. Cutlip, Aaron V. Kaplan, Patrick W. Serruys, Martin B. Leon

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs.

Original languageEnglish (US)
Pages (from-to)1231-1241
Number of pages11
JournalCatheterization and Cardiovascular Interventions
Volume87
Issue number7
DOIs
StatePublished - Jun 1 2016
Externally publishedYes

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Stents
Pathologic Constriction
Therapeutics
Myocardial Infarction
Safety

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Genereux, Philippe ; Kini, Annapoorna ; Lesiak, Maciej ; Kumsars, Indulis ; 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. ; Tarantini, Giuseppe ; Bettinger, Nicolas ; Minalu Ayele, Girma ; 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. / Outcomes of a dedicated stent in coronary bifurcations with large side branches : A subanalysis of the randomized TRYTON bifurcation study. In: Catheterization and Cardiovascular Interventions. 2016 ; Vol. 87, No. 7. pp. 1231-1241.
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title = "Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study",
abstract = "Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59{\%} SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41{\%} of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3{\%} vs. 15.6{\%}, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5{\%} vs. 4.3{\%} P = 0.77) or cardiac death (0{\%} both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4{\%} vs. 40.6{\%}, P = 0.004). Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs.",
author = "Philippe Genereux and Annapoorna Kini and Maciej Lesiak and Indulis Kumsars 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 Giuseppe Tarantini and Nicolas Bettinger and {Minalu Ayele}, Girma 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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language = "English (US)",
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pages = "1231--1241",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
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Genereux, P, Kini, A, Lesiak, M, Kumsars, I, Fontos, G, Slagboom, T, Ungi, I, Metzger, DC, Wykrzykowska, JJ, Stella, PR, Bartorelli, AL, Fearon, WF, Lefèvre, T, Feldman, RL, Tarantini, G, Bettinger, N, Minalu Ayele, G, LaSalle, L, Francese, DP, Onuma, Y, Grundeken, MJ, Garcia-Garcia, HM, Laak, LL, Cutlip, DE, Kaplan, AV, Serruys, PW & Leon, MB 2016, 'Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study', Catheterization and Cardiovascular Interventions, vol. 87, no. 7, pp. 1231-1241. https://doi.org/10.1002/ccd.26240

Outcomes of a dedicated stent in coronary bifurcations with large side branches : A subanalysis of the randomized TRYTON bifurcation study. / Genereux, Philippe; Kini, Annapoorna; Lesiak, Maciej; Kumsars, Indulis; 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.; Tarantini, Giuseppe; Bettinger, Nicolas; Minalu Ayele, Girma; 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: Catheterization and Cardiovascular Interventions, Vol. 87, No. 7, 01.06.2016, p. 1231-1241.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Outcomes of a dedicated stent in coronary bifurcations with large side branches

T2 - A subanalysis of the randomized TRYTON bifurcation study

AU - Genereux, Philippe

AU - Kini, Annapoorna

AU - Lesiak, Maciej

AU - Kumsars, Indulis

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 - Tarantini, Giuseppe

AU - Bettinger, Nicolas

AU - Minalu Ayele, Girma

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 - 2016/6/1

Y1 - 2016/6/1

N2 - Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs.

AB - Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs.

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DO - 10.1002/ccd.26240

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SN - 1522-1946

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