The Tryton® dedicated bifurcation stent: Five-year clinical outcomes

Area of Science:

• Interventional Cardiology
• Biomaterials Science

Background:

• Bifurcation lesions represent a complex challenge in percutaneous coronary intervention.
• The Tryton® Side-Branch Stent was designed to address these complexities.
• Long-term clinical data are crucial for evaluating the safety and efficacy of novel stent designs.

Purpose of the Study:

• To report the first 5-year clinical follow-up data for the Tryton® bifurcation stent.
• To evaluate the safety and efficacy of the Tryton® stent in a real-world setting.
• To compare outcomes between diabetic and non-diabetic patients and across different side branch sizes.

Main Methods:

• Prospective, multi-center clinical follow-up of 173 patients treated with the Tryton® stent.
• Collection of non-hierarchical Major Adverse Cardiovascular Events (MACE) and Major Adverse Cerebrovascular and Cardiovascular Events (MACCE) at 5 years.
• Analysis of outcomes stratified by diabetic status and side branch size (≤2.5 mm vs >2.5 mm).

Main Results:

• A 98% follow-up rate was achieved at 5 years.
• Low rates of non-hierarchical MACE (9.8%), including cardiac death (1.2%) and myocardial infarction (1.7%).
• Target lesion revascularization (TLR) was 6.9%, with only one case (0.6%) of definite, very late stent thrombosis.

Conclusions:

• The Tryton® Side-Branch Stent demonstrated favorable 5-year clinical outcomes with low MACE and MACCE rates.
• While diabetic patients showed higher event rates, lesion complexity based on side branch size did not significantly influence outcomes.
• The stent's safety profile is supported by a very low incidence of stent thrombosis.