Six-month and one-year clinical outcomes after placement of a dedicated coronary bifurcation stent: a patient-level pooled analysis of eight registry studies.
OBJECTIVE
Smaller studies have previously shown promising results after Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA) placement. However, these previous studies were limited by their small sample size and relatively short follow-up. We performed a patient-level pooled analysis to evaluate six-month and one year clinical outcomes of more than 900 patients who were enrolled in eight registries with the Tryton stent.


RESULTS
Data from eight Tryton registries, including 905 patients with 929 bifurcation lesions, were pooled on a patient level to form one dataset. The primary outcome was six-month target vessel failure (TVF), defined as the composite of cardiac death, any myocardial infarction, and clinically indicated target vessel revascularisation. Procedural success was defined as successful stent placement and no in-hospital major adverse cardiac events. Multivariable analysis was performed to determine independent predictors for one-year TVF. Follow-up data were available in 97%. Procedural success was 95% and TVF rate was 6.5% at six months and 8.5% at one year. Stent thrombosis occurred in 0.5% of patients. Left main coronary artery bifurcation lesion (HR 6.46) and main branch reference vessel diameter <3.0 mm (HR 2.62) were independent predictors for TVF.


CONCLUSIONS
In the real world setting of registries including more than 900 patients, the use of the Tryton stent is associated with procedural and mid-term clinical results that compare very favourably with historical studies. The primary endpoint of TVF was primarily determined by reference vessel diameter of the main branch and left main bifurcation lesion location.
Department of Cardiology, University of Amsterdam, Amsterdam, The Netherlands.
Maik J
MJ
Grundeken
Solomon
S
Asgedom
Peter
P
Damman
Maciej
M
Lesiak
Michael S
MS
Norell
Eulogio
E
Garcia
Armando
A
Bethencourt
Pier
P
Woudstra
Karel T
KT
Koch
Marije M
MM
Vis
Jose P S
JP
Henriques
Yoshinobu
Y
Onuma
David P
DP
Foley
Antonio L
AL
Bartorelli
Pieter R
PR
Stella
Jan G P
JG
Tijssen
Robbert J
RJ
de Winter
Joanna J
JJ
Wykrzykowska
D000368:Aged; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality / Q000628:therapy; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000628:therapy; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome