TY - JOUR
T1 - Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER)
AU - Holm, Niels Ramsing
AU - Andreasen, Lene Nyhus
AU - Walsh, Simon
AU - Kajander, Olli A.
AU - Witt, Nils
AU - Eek, Christian
AU - Knaapen, Paul
AU - Koltowski, Lukasz
AU - Gutiérrez-Chico, Juan Luis
AU - Burzotta, Francesco
AU - Kockman, Janusz
AU - Ormiston, John
AU - Santos-Pardo, Irene
AU - Laanmets, Peep
AU - Mylotte, Darren
AU - Madsen, Morten
AU - Hjort, Jakob
AU - Kumsars, Indulis
AU - Råmunddal, Truls
AU - Christiansen, Evald Høj
PY - 2018
Y1 - 2018
N2 - Background 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.Methods and design 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.
AB - Background 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.Methods and design 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.
KW - Aged
KW - Coronary Angiography
KW - Coronary Stenosis
KW - Coronary Vessels
KW - Drug-Eluting Stents
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Percutaneous Coronary Intervention
KW - Tomography, Optical Coherence
KW - Treatment Outcome
KW - Aged
KW - Coronary Angiography
KW - Coronary Stenosis
KW - Coronary Vessels
KW - Drug-Eluting Stents
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Percutaneous Coronary Intervention
KW - Tomography, Optical Coherence
KW - Treatment Outcome
UR - http://hdl.handle.net/10807/158409
U2 - 10.1016/j.ahj.2018.08.003
DO - 10.1016/j.ahj.2018.08.003
M3 - Article
SN - 0002-8703
VL - 205
SP - 97
EP - 109
JO - American Heart Journal
JF - American Heart Journal
ER -