Study Validates Safety of Tryton Stent

The TRYTON dedicated bifurcation stent is confirmed to be safe and effective in treating patients who have coronary bifurcations with side branches of 2.25 mm or larger, according to data presented in a Featured Clinical Research session on Monday.    

Philippe Genéréux, MD, of Hôpital du Sacré-Coeur de Montréal, Canada, and CRF, New York, N.Y., and colleagues conducted the TRYTON confirmatory study to prospectively assess the safety of the Tryton dedicated bifurcation stent (Tryton Medical) in patients with true bifurcation lesions involving large side branches.

“Bifurcation lesions are frequent and remain a challenge, requiring more time, skill and equipment costs,” said Genéréux. “These lesions are associated with an increase in peri-procedural MIs, stent thrombosis, restenosis and suboptimal angiographic outcomes, especially side branch ostium at long-term follow-up. One of the reasons the Tryton stent failed in certain patients in the initial trial was that 60% of patients enrolled had side branches that were less than 2.25 mm – this is why we conducted a subanalysis.”  

Patients (n = 133) were recruited across 28 investigational sites including 13 U.S. centers. Mean age was 66 years, 70% of patients were male, 82% had hypertension and 71% had hypercholesterolemia.

Nearly all patients achieved a final in-stent residual stenosis less than 30% without device malfunction. All patients achieved a final in-stent diameter less than 50% within the side branch (Figure).   

The rate of periprocedural MI (CK-MB ≥ 3 times the upper limit of normal; primary endpoint) was 10.5%, less than the performance goal of 17.9%. In addition, there were no deaths or cases of stent thrombosis during 30-day follow-up. 

“For me, we have confirmation to keep the branch open when it is needed, especially [in] patients with a large side branch. These data are reassuring. We do not know when the company will move forward with the stent, but we know for certain it is safe and effective,” said Genéréux. “In light of the higher procedural success rate, improved acute angiographic results and a higher rate of side branch patency at 9-month follow-up compared to provisional stenting, the TRYTON Confirmatory Study and the TRYTON trial support the use of the dedicated bifurcation Tryton stent in conjunction with standard DES in the treatment of bifurcation lesions involving large side branches.”

Disclosures: 

• Généreux reports receiving consultant/honoraria fees from Abbott Vascular, Cardiovascular Systems, Inc., Edwards Lifesciences and Pi-Cardia as well as grant/research support from Boston Scientific Corporation, Cardiovascular Systems, Inc. and Tryton Medical.