Author + information
- Received October 5, 2014
- Revision received October 22, 2014
- Accepted November 19, 2014
- Published online February 17, 2015.
- Philippe Généreux, MD∗,†,‡,
- Indulis Kumsars, MD§,
- Maciej Lesiak, MD‖,
- Annapoorna Kini, MD¶,
- Géza Fontos, MD#,
- Ton Slagboom, MD∗∗,
- Imre Ungi, MD, PhD††,
- D. Christopher Metzger, MD‡‡,
- Joanna J. Wykrzykowska, MD, PhD§§,
- Pieter R. Stella, MD, PhD‖‖,
- Antonio L. Bartorelli, MD¶¶,
- William F. Fearon, MD##,
- Thierry Lefèvre, MD∗∗∗,
- Robert L. Feldman, MD†††,
- Laura LaSalle, MPH†,
- Dominic P. Francese, MPH†,
- Yoshinobu Onuma, MD, PhD‡‡‡,
- Maik J. Grundeken, MD§§,
- Hector M. Garcia-Garcia, MD, PhD‡‡‡,
- Linda L. Laak, BSN§§§,
- Donald E. Cutlip, MD‖‖‖,
- Aaron V. Kaplan, MD§§§,¶¶¶,
- Patrick W. Serruys, MD, PhD‡‡‡ and
- Martin B. Leon, MD∗,†∗ ()
- ∗Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- †Cardiovascular Research Foundation, New York, New York
- ‡Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada
- §Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia
- ‖1st Department of Cardiology, University of Medical Sciences, Poznan, Poland
- ¶Mount Sinai Medical Center, New York, New York
- #Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary
- ∗∗Department of Cardiology, OLVG, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
- ††2nd Department of Medicine and Cardiology Center, Medical Faculty, Albert Szent-Györgyi Clinical Center, University of Szeged, Department of Cardiology, Szeged, Hungary
- ‡‡Wellmont CVA Heart Institute, Kingsport, Tennessee
- §§Department of Cardiology, Amsterdam Medical Center, Amsterdam, the Netherlands
- ‖‖University Medical Center Utrecht, Department of Interventional Cardiology, Utrecht, the Netherlands
- ¶¶Centro Cardiologico Monzino, University of Milan, Milan, Italy
- ##Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California
- ∗∗∗Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
- †††MediQuest Research Group, Ocala, Florida
- ‡‡‡Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- §§§Tryton Medical Inc., Durham, North Carolina
- ‖‖‖Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ¶¶¶Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
- ↵∗Reprint requests and correspondence:
Dr. Martin B. Leon, Columbia University Medical Center, New York-Presbyterian Hospital, 161 Fort Washington Avenue, 6th Floor, New York, New York 10032.
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)
Funding for the TRYTON was provided by Tryton Medical, Inc. Dr. Généreux has received speaker fees from Abbott Vascular; and was a consultant for Cardiovascular Systems Inc. Dr. Kumsars has received speaker fees from AstraZeneca and Tryton Medical, Inc. Dr. Lesiak has served as a speaker and a consultant for Abbott Vascular, Boston Scientific, Biotronik, B Braun, AstraZeneca, Eli Lilly, and Tryton Medical Inc. Dr. Metzger was a consultant for Abbott Vascular, Cordis, IDEV, Medtronic, Volcano, Bard, Spectranetics, and Boston Scientific. Dr. Wykrzykowska has received speaker and consultancy fees from Abbott, Tryton Medical, Inc., and Stentys. Dr. Stella was a consultant for Mentice; and a proctor for Edwards Lifesciences. Dr. Bartorelli was a consultant for Abbott Vascular; and has received speaker fees from Abbott Vascular, Tryton Medical, Inc., and St. Jude. Dr. Fearon has received research support from St. Jude Medical and Medtronic; and speaker fees from Medtronic. Dr. Lefèvre has received speaker fees from Abbott Vascular, Terumo, Boston Scientific, and Medtronic. Dr. Feldman is on the advisory board for Boston Scientific. Linda L. Laak is a full-time employee of Tryton Medical, Inc. Dr. Cutlip has received research support from Medtronic, Boston Scientific, Abbott Vascular, CeloNova, and Tryton Medical, Inc. Dr. Kaplan is a member of the board of directors for Tryton Medical, Inc. Dr. Leon is on the scientific advisory boards of Abbott Vascular, Boston Scientific, and Medtronic; and is the principal investigator of the TRYTON bifurcation trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 5, 2014.
- Revision received October 22, 2014.
- Accepted November 19, 2014.
- American College of Cardiology Foundation