Tryton Medical said yesterday that data from a post hoc analysis of a randomized clinical trial of its Tryton side branch stent for patients with coronary bifurcation lesions showed reductions in target vessel failure and improved side branch diameter.
Results from the study were published in the journal Catheterization and Cardiovascular Interventions.
The 289-patient post-hoc analysis focused on patients with side branch bifurcation lesions 2.25 mm in diameter or greater.
The study reported that target vessel failure was lower in the Tryton-treated group compared to the control, and that patients treated with the company’s stent showed lower side branch diameter stentosis at 9-months follow up. There was no reported differencei n the rate of binary restenosis reported.
“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 RCT provides strong support for the safety and efficacy of the Tryton Side Branch Stent compared with a provisional stenting strategy,” lead study author Dr. Martin Leon of the Columbia University Medical Center in New York said in prepared remarks.
The data came from the company’s pivotal study of its Tryton side branch stent, the largest ever conducted on coronary bifurcation lesions, which failed to meet its primary endpoint for target vessel failure in March.
Results from the 704-patient, randomized study, published this month in the Journal of the American College of Cardiology, showed that at 9 months TVF was 17.4% in the cohort treated with the Tryton device, compared with 12.8% for the control group treated with a provisional stent and balloon angioplasty (p = 0.11).
The researchers put the discrepancy down in part to a higher rate of periprocedural myocardial infarction in the Tryton group (13.6% vs. 10.1%, p = 0.19).
“Provisional stenting should remain the preferred strategy for treatment of non–left main true coronary bifurcation lesions,” the researchers wrote.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.