RT Journal Article
T1 Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER).
A1 Holm, Niels Ramsing
A1 Andreasen, Lene Nyhus
A1 Walsh, Simon
A1 Kajander, Olli A
A1 Witt, Nils
A1 Eek, Christian
A1 Knaapen, Paul
A1 Koltowski, Lukasz
A1 Gutiérrez-Chico, Juan Luis
A1 Burzotta, Francesco
A1 Kockman, Janusz
A1 Ormiston, John
A1 Santos-Pardo, Irene
A1 Laanmets, Peep
A1 Mylotte, Darren
A1 Madsen, Morten
A1 Hjort, Jakob
A1 Kumsars, Indulis
A1 Råmunddal, Truls
A1 Christiansen, Evald Høj
AB Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome. OCTOBER is a randomized, investigator-initiated, multicenter trial aimed to show superiority of OCT-guided stent implantation compared to standard angiographic-guided implantation in bifurcation lesions. The primary outcome measure is a 2-year composite end point of cardiac death, target lesion myocardial infarction, and ischemia-driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized non–ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter ≥2.5mm. Treatment is performed by the provisional side branch stenting technique or 2-stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results. A positive outcome of the OCTOBER trial may establish OCT as a routine tool for optimization of complex percutaneous coronary intervention, whereas a negative result would indicate that OCT remains a tool for ad hoc evaluation in selected cases.
YR 2018
FD 2018-08-16
LK https://hdl.handle.net/10668/24996
UL https://hdl.handle.net/10668/24996
LA en
DS RISalud
RD Aug 6, 2025