A Randomized Trial of a Dedicated Bifurcation Stent Versus Provisional Stenting in the Treatment of Coronary Bifurcation Lesions
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). The TRYTON (Prospective, Single Blind, Randomized Controlled Study to...
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Published in | Journal of the American College of Cardiology Vol. 65; no. 6; pp. 533 - 543 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Inc
17.02.2015
Elsevier Limited |
Subjects | |
Online Access | Get full text |
ISSN | 0735-1097 1558-3597 1558-3597 |
DOI | 10.1016/j.jacc.2014.11.031 |
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Abstract | 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).
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.
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.
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).
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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AbstractList | 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).
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.
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.
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).
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). 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).BACKGROUNDBifurcation 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).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.OBJECTIVESThe 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.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.METHODSWe 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.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).RESULTSWe 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).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).CONCLUSIONSProvisional 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). 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) AbstractBackgroundBifurcation 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). ObjectivesThe 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. MethodsWe 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. ResultsWe 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). ConclusionsProvisional 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) 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). 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. 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. 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). 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 | LaSalle, Laura Garcia-Garcia, Hector M. Fontos, Géza Francese, Dominic P. Kumsars, Indulis Ungi, Imre Kaplan, Aaron V. Bartorelli, Antonio L. Slagboom, Ton Metzger, D. Christopher Généreux, Philippe Wykrzykowska, Joanna J. Lesiak, Maciej Lefèvre, Thierry Feldman, Robert L. Grundeken, Maik J. Leon, Martin B. Serruys, Patrick W. Laak, Linda L. Cutlip, Donald E. Fearon, William F. Kini, Annapoorna Stella, Pieter R. Onuma, Yoshinobu |
Author_xml | – sequence: 1 givenname: Philippe surname: Généreux fullname: Généreux, Philippe organization: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York – sequence: 2 givenname: Indulis surname: Kumsars fullname: Kumsars, Indulis organization: Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia – sequence: 3 givenname: Maciej surname: Lesiak fullname: Lesiak, Maciej organization: 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland – sequence: 4 givenname: Annapoorna surname: Kini fullname: Kini, Annapoorna organization: Mount Sinai Medical Center, New York, New York – sequence: 5 givenname: Géza surname: Fontos fullname: Fontos, Géza organization: Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary – sequence: 6 givenname: Ton surname: Slagboom fullname: Slagboom, Ton organization: Department of Cardiology, OLVG, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands – sequence: 7 givenname: Imre surname: Ungi fullname: Ungi, Imre organization: 2nd Department of Medicine and Cardiology Center, Medical Faculty, Albert Szent-Györgyi Clinical Center, University of Szeged, Department of Cardiology, Szeged, Hungary – sequence: 8 givenname: D. Christopher surname: Metzger fullname: Metzger, D. Christopher organization: Wellmont CVA Heart Institute, Kingsport, Tennessee – sequence: 9 givenname: Joanna J. surname: Wykrzykowska fullname: Wykrzykowska, Joanna J. organization: Department of Cardiology, Amsterdam Medical Center, Amsterdam, the Netherlands – sequence: 10 givenname: Pieter R. surname: Stella fullname: Stella, Pieter R. organization: University Medical Center Utrecht, Department of Interventional Cardiology, Utrecht, the Netherlands – sequence: 11 givenname: Antonio L. surname: Bartorelli fullname: Bartorelli, Antonio L. organization: Centro Cardiologico Monzino, University of Milan, Milan, Italy – sequence: 12 givenname: William F. surname: Fearon fullname: Fearon, William F. organization: Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California – sequence: 13 givenname: Thierry surname: Lefèvre fullname: Lefèvre, Thierry organization: Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France – sequence: 14 givenname: Robert L. surname: Feldman fullname: Feldman, Robert L. organization: MediQuest Research Group, Ocala, Florida – sequence: 15 givenname: Laura surname: LaSalle fullname: LaSalle, Laura organization: Cardiovascular Research Foundation, New York, New York – sequence: 16 givenname: Dominic P. surname: Francese fullname: Francese, Dominic P. organization: Cardiovascular Research Foundation, New York, New York – sequence: 17 givenname: Yoshinobu surname: Onuma fullname: Onuma, Yoshinobu organization: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands – sequence: 18 givenname: Maik J. surname: Grundeken fullname: Grundeken, Maik J. organization: Department of Cardiology, Amsterdam Medical Center, Amsterdam, the Netherlands – sequence: 19 givenname: Hector M. surname: Garcia-Garcia fullname: Garcia-Garcia, Hector M. organization: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands – sequence: 20 givenname: Linda L. surname: Laak fullname: Laak, Linda L. organization: Tryton Medical Inc., Durham, North Carolina – sequence: 21 givenname: Donald E. surname: Cutlip fullname: Cutlip, Donald E. organization: Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts – sequence: 22 givenname: Aaron V. surname: Kaplan fullname: Kaplan, Aaron V. organization: Tryton Medical Inc., Durham, North Carolina – sequence: 23 givenname: Patrick W. surname: Serruys fullname: Serruys, Patrick W. organization: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands – sequence: 24 givenname: Martin B. surname: Leon fullname: Leon, Martin B. email: ml2398@columbia.edu organization: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25677311$$D View this record in MEDLINE/PubMed |
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Copyright | 2015 American College of Cardiology Foundation American College of Cardiology Foundation Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. Copyright Elsevier Limited Feb 17, 2015 |
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Snippet | Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a... AbstractBackgroundBifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current... Background Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence... |
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SubjectTerms | Angioplasty Angioplasty, Balloon, Coronary - methods Cardiology Cardiovascular Cardiovascular disease Coronary Angiography coronary bifurcation Coronary Stenosis - diagnostic imaging Coronary Stenosis - surgery coronary stent Coronary vessels Coronary Vessels - surgery Drug-Eluting Stents Europe Female Follow-Up Studies Heart attacks Humans Male Middle Aged Mortality PCI Prospective Studies Prosthesis Design Single-Blind Method Stents Success Thrombosis Time Factors Treatment Outcome United States |
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Title | A Randomized Trial of a Dedicated Bifurcation Stent Versus Provisional Stenting in the Treatment of Coronary Bifurcation Lesions |
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