Aims: The percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents. Dedicated bifurcation stents could provide an attractive alternative to improve early outcomes and reduce SB restenosis. We aimed to assess in a prospective single-arm multicentre registry, safety and effectiveness at 6-month clinical follow-up of the Tryton dedicated side branch (SB) stent.
Methods and results: In this prospective international registry, patients with coronary bifurcation lesions underwent treatment with a dedicated stenting technique using the Tryton stent, in conjunction with a "workhorse" main branch (MB) stent (drug-eluting or bare metal). The Tryton stent is specifically designed for bifurcations, with minimal strut/vessel ratio in the proximal MB, providing full strut coverage at the SB ostium, with short stent length in the SB and with the ability to adapt to the wide spectrum of bifurcation angles and sizes. The primary endpoint was 6-month major adverse cardiac events (MACE: cardiac death, myocardial infarction and target lesion revascularisation). Secondary endpoints were technical and procedural success (respectively defined as successful implantation of Tryton at the intended lesion and successful performance of the whole procedure with Tryton without in-hospital MACE). A total of 302 patients were enrolled. Of these, 296 had 6-month data available for evaluation. Technical and procedural success occurred in 98.0% (95% confidence interval: 95.7%-99.1%) and 94.4% (91.2%-96.5%) patients, respectively. The cumulative 6-month MACE rate was 6.4% (4.2%-9.7%), including 4.7% (2.9%-7.7%) myocardial infarctions (3.7% periprocedural), and 3.4% (2.0%-6.1%) target lesion revascularisations (2.4% in the MB, 0.7% in the SB, and 0.3% in both MB and SB). One stent thrombosis (0.3% [0%-1.6%]) occurred.
Conclusions: The treatment of bifurcation lesions with a dedicated Tryton stent is safe and feasible, with good technical and procedural success, very low revascularisation, MACE and stent thrombosis rates at 6-month clinical follow-up.