March 1, 2008EuroIntervention
Tryton I, First-In-Man (FIM) study: six month clinical and angiographic outcome, analysis with new quantitative coronary angiography dedicated for bifurcation lesions
Key result
Tryton side-branch stent with standard DES achieves ~93% freedom from in-hospital MACE in bifurcation lesions.
- n=30
Why the study?
Clinical and angiographic outcomes after implantation of the Tryton Side-Branch Stent dedicated to bifurcation lesions were not previously reported.
Does the Tryton Side-Branch Stent in conjunction with a standard DES provide acceptable clinical and angiographic outcomes in patients with de novo bifurcation lesions?
Comparison
Tryton Side-Branch Stent plus standard workhorse DES vs no comparator
Design
First-in-man case series study
Follow-up
6 months
Authors
Discussion
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Member takes
Implication
Registry data support Tryton feasibility in bifurcations with low 6-month MACE; leaves open randomized efficacy versus provisional stenting.
Structured PICO
Does the Tryton Side-Branch Stent in conjunction with a standard DES provide acceptable clinical and angiographic outcomes in patients with de novo bifurcation lesions?
P
Population
30 patients with angina or silent myocardial ischaemia and de novo bifurcation lesions, followed for 6 months.
I
Intervention
Tryton Side-Branch Stent placed in the side-branch in conjunction with a standard workhorse drug-eluting stent (DES) subsequently implanted in the main-branch.
O
Outcome
Freedom from in-hospital major adverse cardiac events (MACE) following procedural success.composite
The Tryton side-branch stent used with a standard DES for bifurcation lesions demonstrated acceptable clinical outcomes and low side-branch late loss at 6 months in a first-in-man study.
Cite This Study
Onuma et al. (2008) studied Angina or silent myocardial ischaemia with de novo bifurcation lesions (n=30). Tryton Side-Branch Stent in conjunction with standard workhorse drug-eluting stent (DES) was evaluated on Freedom from in-hospital major adverse cardiac events (MACE) following procedural success. Implantation of the Tryton side-branch stent in conjunction with a standard DES achieved freedom from in-hospital MACE in 93.3% of patients with de novo bifurcation lesions.