Dedicated side branch stent shows promising results in TRYTON post hoc analysis
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In a post hoc analysis of the randomized TRYTON trial, a dedicated side branch stent reduced target vessel failure and improved side branch percent diameter stenosis in patients with bifurcation lesions involving large side branches.
“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,” principal investigator Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital, said in a press release.
Martin B. Leon
Leon and colleagues conducted the subanalysis in 289 patients with bifurcation lesions in vessels at least 2.25 mm in diameter, based on quantitative coronary angiography. The original TRYTON trial involved 704 patients with smaller diameter vessels (59% with side branches ≤ 2.25 mm).
Patients received the dedicated bifurcation bare-metal stent (Tryton side branch stent, Tryton Medical) or balloon angioplasty.
The investigators assessed target vessel failure as the primary endpoint and angiographic percent diameter stenosis in the side branch as the secondary endpoint at 9 months.
The initial trial failed to meet its primary endpoint because of a high periprocedural MI rate. Inside the cohort, the investigators compared the rates between the 146 patients who received the dedicated side branch stent and the 143 patients who received provisional stenting.
Target vessel failure was lower with side branch vs. provisional stenting (11.3% vs. 15.6%, P = .38) and was within the margin of noninferiority. Investigators observed no differences in clinically driven target vessel revascularization with side branch vs. provisional stenting (3.5% vs. 4.3% P = .77). No cardiac deaths occurred in either group. In-segment percent diameter stenosis of the side branch was lower with side branch vs. provisional stenting (30.4% vs. 40.6%, P = .004).
“This analysis … provides strong support for the safety and efficacy of the Tryton side branch stent compared with a provisional stenting strategy,” Leon said. – by Allegra Tiver
Disclosure: Funding for TRYTON was provided by Tryton Medical Inc. Leon reports serving on the scientific advisory board for Abbott Vascular, Boston Scientific and Medtronic, and was the principal investigator of the TRYTON trial. Please see the full study for a list of all other authors’ relevant financial disclosures.