A post-hoc analysis of the Tryton randomised controlled trial—now published in Catheterization and Cardiovascular Interventions—show that the Tryton side-branch stent is associated with reduced target vessel failure and improved side branch percent diameter stenosis in patients with vessels ≥2.25mm in diameter. The analysis examined the use of the Tryton side-branch stent compared with provisional stenting in the intended treatment population of patients with a coronary bifurcation lesion in vessels ≥2.25mm in diameter determined by quantitative coronary angiography (QCA).
In the post-hoc analysis of 289 patients with a coronary bifurcation lesion involving a side branch ≥2.25mm in diameter, target vessel failure, the primary endpoint, was numerically lower among the Tryton group compared to the provisional group. The Tryton side-branch stent demonstrated a statistically significant lower side branch percent diameter stenosis at nine month follow up compared with the provisional group (30.4% vs. 40.6%, P=0.004). In addition, the Tryton side-branch stent reduced the need for additional side branch “bail-out” stenting compared with the provisional approach (0.7% vs. 5.6%; p=0.02). There was no significant difference in the rate of binary restenosis.
The study authors, Martin B Leon (director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, New York, USA) and others, report that both the Tryton device and provisional treatment strategies were shown to have similarly low rates of stent thrombosis and no cardiac deaths were reported at nine months. Leon says: “Coronary bifurcation lesions present a number of challenges for interventional cardiologists because each patient can present with varying vessel sizes and there is a wide range of angulations between the main vessel and side branch. For the treatment of bifurcation lesions involving significant side branches, this analysis of the pivotal Tryton randomised controlled trial provides strong support for the safety and efficacy of the Tryton Side Branch Stent compared with a provisional stenting strategy.”