Author + information
- Green Peregrine1,
- Pieter Stella2,
- Indulis Kumsārs3,
- Jo Dens4,
- Jeroen Sonck5,
- Johan Bennett6,
- Armando Bethencourt7,
- Benigno Ramos López8,
- Dariusz Dudek9,
- Robert van Geuns10 and
- Steve Ramcharitar1
- 1Wiltshire cardiac Centre, Swindon, United Kingdom
- 2Dept. of Interventional Cardiology, University Medical Centre, Utrecht, Netherlands
- 3Paula Stradiņa klīniskā universitātes slimnīca, Rīga, Latvia
- 4Ziekenhuis Oost-Limburg, Limburg, Belgium
- 5Universitair Ziekenhuis Brussel, Brussels, Belgium
- 6Catholic University of Leuven, Leuven, Belgium
- 7Hospital Son Dureta de Palma de Mallorca, Palma, Spain
- 8Clinico Univ Valladolid, Valladolid, Spain
- 9University Hospital, Krakow, Poland
- 10Thoraxcentre, Rotterdam, Netherlands
To evaluate 5 year clinical outcomes of the TrytonTM dedicated Side-Branch Stent in a real-world population.
The Tryton TM is an established stent for bifurcating lesions with disease involving the side branch. Although the six month follow-up has been reported there is no clinical data at 5 years particularly in view of the updated and current Society for Cardiovascular Angiography and Interventions (SCAI) definition for myocardial infarction (MI) in the follow-up phase. The earlier definition of 2xCKMB was used in the first in man (FIM) and at discharge. Comparator 5 year result as in the Nordic Bifurcation Study using the older MI definitions reveal Major Adverse Cardiovascular Events (MACE) (cardiac death, [MI] and target lesion revascularization [TLR]) of 15.8% to 21.8%, depending on whether the side branch was routinely stented. The Tryton TM is a bare metal stent (BMS) but there is encouraging data in recent 5 years follow-up in the NORSTENT trial where no difference in death or MI between BMS and drug-eluting stents was reported.
Clinical outcomes at five years from stent implantation were collected from 8 large centers across Europe having high volume bifurcation operators. Patient’s demographics, lesion characteristics, MACE and Major Adverse Cerebrovascular and Cardiovascular Events (MACCE) (MACE plus stroke and major bleeding in addition) were all collected via an electronic CRF and through an independent data analyst ClinFlows, Bielefeld, Germany.
171 patients with a follow up rate of 96% at 5 years from 8 responding centers were analyzed. The eTryton database had 300 patients with 5 year data however not all centers responded. Overall MACE were low at 10%, consisting of cardiac death 1.2% (n=2), a low observed MI of 1.8% (n=3) based on the earlier FIM and later SCAI definitions. A TLR of 7.0% (n=12) was observed. MACCE rates were also low, with major bleeding occurring in only 2.3% (n=4) and strokes in 1.8% (n=3) of patients. Interestingly, there was only 1 case (0.6%) of stent thrombosis that was definite and it occurred very late (782 days). All cause mortality was low, with 8.8% combined cardiac and non-cardiac death (n=15).
The Tryton Side-Branch StentTM had a MACE of 10% and MACCE 15.1% at 5 years in 8 high volume centers. Despite being a BMS the TLR was 7.0% with only 1 case of definite stent thrombosis recorded at 782 days.