Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions.

AIM: To report clinical and angiographic follow-up at 6 months after implantation of the Tryton Side-Branch Stent dedicated to bifurcation, in conjunction with standard workhorse drug-eluting stent (DES). METHODS AND
RESULTS: Patients having angina or silent myocardial ischaemia with de novo bifurcation lesions were enrolled at three sites. The Tryton stent was first placed in the side-branch and a standard DES subsequently implanted in the main-branch. The primary endpoint was freedom from in-hospital major adverse cardiac events (MACE) following procedural success. Angiographic and clinical follow-up was performed at 6-months. Quantitative coronary angiography (QCA) was analysed with a new dedicated bifurcation software. Thirty patients were enrolled. At six months clinical follow-up was available in 100% with angiographic follow-up performed in 78%. The primary endpoint was met in 93.3%. The MACE rate at 6 months was 9.9%. QCA analysis demonstrated late luminal loss of 0.17 mm with no restenosis in the side branch.
CONCLUSIONS: In conjunction with a workhorse DES to treat bifurcation lesions, the Tryton side-branch stent demonstrated acceptable clinical outcome and low side-branch late loss at six months.