Author + information
- Received January 15, 2016
- Revision received March 7, 2016
- Accepted March 24, 2016
- Published online July 11, 2016.
- Philippe Généreux, MDa,b,c,
- Indulis Kumsars, MDd,
- Joel E. Schneider, MDe,
- Maciej Lesiak, MDf,
- Björn Redfors, MD, PhDa,
- Kristoff Cornelis, MDg,
- Matthew R. Selmon, MDh,
- Jo Dens, MD, PhDi,
- Angela Hoye, MDj,
- D. Christopher Metzger, MDk,
- Luc Muyldermans, MDl,
- Ton Slagboom, MDm,
- Dominic P. Francese, MPHa,
- Girma Minalu Ayele, PhDa,
- Linda L. Laak, BSNn,
- Antonio L. Bartorelli, MDo,
- Donald E. Cutlip, MDp,
- Aaron V. Kaplan, MDn,q and
- Martin B. Leon, MDa,b,∗ ()
- aCardiovascular Research Foundation, New York, New York
- bNewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- cHôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada
- dLatvian Centre of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia
- eNorth Carolina Heart and Vascular, Raleigh, North Carolina
- fKarol Marcinkowski University of Medical Sciences, Pozan, Poland
- gAZ Maria Middelares, Gent, Belgium
- hAustin Heart PLLC, Austin, Texas
- iZiekenhuis Oost-Limburg, Genk, Belgium
- jCastle Hill Hospital, East Yorkshire, United Kingdom
- kWellmont CVA Heart Institute, Kingsport, Tennessee
- lAZ Sint Jan, Bruges, Belgium
- mDepartment of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
- nTryton Medical, Inc., Durham, North Carolina
- oMonzino Hospital, Milan, Italy
- pHarvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- qDartmouth-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.
Objectives The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs).
Background The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled.
Methods The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT.
Results Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint.
Conclusions The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.
Dr. Généreux has received speaking fees from Abbott Vascular; and is a consultant for Cardiovascular Systems. Dr. Kumsars has received speaking fees from AstraZeneca and Tryton Medical. Dr. Lesiak has received speaking and consulting fees from Abbott Vascular, Boston Scientific, Biotronik, B Braun, and AstraZeneca. Dr. Metzger is a consultant for Abbott Vascular, Cordis, IDEV, Medtronic, and Volcano. Dr. Laak is a full-time employee of Tryton Medical. Dr. Bartorelli is a consultant for Abbott Vascular; and has received speaking fees from Abbott Vascular, Tryton Medical, and St. Jude Medical. Dr. Cutlip has received research support from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Kaplan is a member of the board of directors of Tryton Medical. Dr. Leon is a member of the scientific advisory boards of Abbott Vascular, Boston Scientific, and Medtronic; and is 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 January 15, 2016.
- Revision received March 7, 2016.
- Accepted March 24, 2016.
- American College of Cardiology Foundation