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 inJournal of the American College of Cardiology Vol. 65; no. 6; pp. 533 - 543
Main Authors Généreux, 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.
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 17.02.2015
Elsevier Limited
Subjects
Online AccessGet full text
ISSN0735-1097
1558-3597
1558-3597
DOI10.1016/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)
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
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  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
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  givenname: Maciej
  surname: Lesiak
  fullname: Lesiak, Maciej
  organization: 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland
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  givenname: Annapoorna
  surname: Kini
  fullname: Kini, Annapoorna
  organization: Mount Sinai Medical Center, New York, New York
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  surname: Fontos
  fullname: Fontos, Géza
  organization: Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary
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  fullname: Slagboom, Ton
  organization: Department of Cardiology, OLVG, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
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  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
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  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
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  givenname: Pieter R.
  surname: Stella
  fullname: Stella, Pieter R.
  organization: University Medical Center Utrecht, Department of Interventional Cardiology, Utrecht, the Netherlands
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  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
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  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
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  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
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  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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Issue 6
Keywords TVR
DES
MB
TVF
PCI
CK
coronary bifurcation
coronary stent
MI
QCA
SB
target vessel failure
myocardial infarction
drug-eluting stent(s)
quantitative coronary angiography
side branch
percutaneous coronary intervention
main branch
target vessel revascularization
creatine kinase
Language English
License http://www.elsevier.com/open-access/userlicense/1.0
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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25677312 - J Am Coll Cardiol. 2015 Feb 17;65(6):544-5
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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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StartPage 533
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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