Philippe Généreux1,2,3, Annapoorna Kini4, Maciej Lesiak5, Indulis Kumsars6, Géza Fontos7, Ton Slagboom8, Imre Ungi9, D Christopher Metzger10, Joanna J Wykrzykowska11, Pieter R Stella12, Antonio L Bartorelli13, William F Fearon14, Thierry Lefèvre15, Robert L Feldman16, Giuseppe Tarantini17, Nicolas Bettinger1,2, Girma Minalu Ayele2, Laura LaSalle2, Dominic P Francese2, Yoshinobu Onuma18, Maik J Grundeken11, Hector M Garcia-Garcia18, Linda L Laak19, Donald E Cutlip20, Aaron V Kaplan19,21, Patrick W Serruys18, Martin B Leon1,2. 1. Columbia University Medical Center/NewYork Presbyterian Hospital, New York, New York. 2. Cardiovascular Research Foundation, New York, New York. 3. Hôpital Du Sacré-Coeur De Montréal, Université De Montréal, Montréal, Québec, Canada. 4. Mount Sinai Medical Center, New York, New York. 5. 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland. 6. Latvian Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia. 7. Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary. 8. Department of Cardiology, OLVG, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 9. 2nd Department of Medicine and Cardiology Center Medical Faculty, Albert Szent-Györgyi Clinical Center, University of Szeged- Department of Cardiology, Szeged, Hungary. 10. Wellmont CVA Heart Institute, Kingsport, Tennessee. 11. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands. 12. Department of Interventional Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. 13. Centro Cardiologico Monzino, University of Milan, Milan, Italy. 14. Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, California. 15. Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France. 16. MediQuest Research Group, Ocala, Florida. 17. Azienda Ospedaliera Di Padova, Padova, Italy. 18. Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 19. Tryton Medical Inc., Durham, North Carolina. 20. Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 21. Dartmouth-Hitchcock Medical Center, New Hampshire, Lebanon.
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.
RCT Entities:
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.
Authors: Larragem Parsley-Raines; Dominique M Brandt; Dillon L Carr; Sabrina Uhry; Eileen S Alexander; Stephanie A Donauer; Peter J Mallow Journal: J Health Econ Outcomes Res Date: 2019-04-26