The Tryton Side Branch Stent™ for the treatment of coronary bifurcation lesions

Abstract

Coronary bifurcation lesions account for approximately 15% of all percutaneous coronary interventions (PCI) performed. Although clinical outcomes after PCI have been improved considerably, PCI of bifurcation lesions remains to be associated with adverse clinical events, when compared with non-bifurcation PCI. Therefore, several dedicated bifurcation devices have been developed to improve clinical outcomes. The Tryton Side Branch Stent^™ is such device and is used in combination with a regular tubular balloon expandable stent in the main branch. Multiple single and multicenter registries and a patient pooled analysis including 900 patients have shown promising results regarding clinical outcomes after bifurcation PCI with Tryton. The pivotal Tryton IDE randomized trial is currently underway comparing the Tryton stent with side branch balloon angioplasty as side branch treatment in bifurcation lesions challenging the current dogma of provisional single stent strategy as treatment for coronary bifurcation lesions.

Keywords::

• coronary artery disease
• coronary bifurcation lesions
• dedicated bifurcation stent
• percutaneous coronary intervention
• Tryton Side Branch Stent

Financial & competing interests disclosure

MJ Grundeken and JJ Wykrzykowska receive consultancy fees from Tryton Medical. PR Stella is a member of the Tryton IDE trial steering committee. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • Coronary bifurcation lesions accounts for approximately 15% of all percutaneous coronary interventions performed and are associated with an increased risk of adverse clinical events during follow-up when compared with non-bifurcation lesions.

• • Dedicated bifurcation devices such as the Tryton Side Branch Stent have been developed to improve clinical outcomes.

• • The stent has a specific stent design (the Tri ZONE technology): a distal side branch (SB) zone scaffolding the SB, a central transition zone with three panels to adjust to the wide variety of carinal anatomies and to provide scaffolding of the SB ostium, and a proximal main branch (MB) zone with two wedding bands anchoring the stent and a minimum amount of metal allowing easy delivery of the MB stent.

• • Until now, only observational data is available on the Tryton confirming the safety and feasibility of the stent with promising clinical results as shown in a large patient-pooled analysis showing a target vessel failure rate of 8.5% at one year.

• • Currently, the pivotal Tryton IDE trial is running comparing Tryton with balloon angioplasty as side branch treatment, both in combination with a conventional drug-eluting stent in the MB, challenging the current dogma of single stenting in bifurcation lesions.

Notes