Tryton Medical Announces Publication of Post Hoc Analysis of Randomized Clinical Trial in Treatment of Bifurcation Lesions using Tryton Side Branch Stent

Analysis showed reductions in target vessel failure and improved side branch percent diameter stenosis in patients with a coronary bifurcation lesion in vessels 2.25mm in diameter or greater

DURHAM, N.C.,  Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced that results of a post hoc analysis of the pivotal Tryton Randomized Clinical Trial (RCT) have been published in the peer-reviewed journal Catheterization and Cardiovascular Interventions (CCI), the official publication of the Society for Cardiovascular Angiography and Interventions (SCAI). The analysis, “Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study,” examines 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 or greater determined by quantitative coronary angiography (QCA).

The study authors, led by Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, conclude that treatment with the Tryton Side Branch Stent showed reductions in target vessel failure and improved side branch percent diameter stenosis in the population of patients with lesions involving side branches that were 2.25mm in diameter or greater. Both the Tryton Side Branch Stent and provisional treatment strategies were shown to have similarly low rates of stent thrombosis and no cardiac deaths were reported at nine months.

“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,” said Dr. Leon. “For the treatment of bifurcation lesions involving significant side branches, this analysis of the pivotal Tryton RCT provides strong support for the safety and efficacy of the Tryton Side Branch Stent compared with a provisional stenting strategy.”

In the post hoc analysis of 289 patients with a coronary bifurcation lesion involving a side branch greater than or equal to 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.

“We welcome the results of this post hoc analysis in patients with large side branches as an important step towards bringing a dedicated stent to cardiologists in the United States, and addressing challenges in treating significant coronary bifurcation lesions,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “We recently completed enrollment in the Tryton Confirmatory Study, a single-arm study of our dedicated stent designed to confirm results from the pivotal Tryton RCT study in our intended population of patients with coronary bifurcation lesions involving side branches that are 2.25mm in diameter or greater. We plan to present findings from this study at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting in the coming weeks.”

Source: BusinessWire