Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER)

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 opt...

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Published in:	The American heart journal Vol. 205; pp. 97 - 109
Main Authors:	Holm, Niels Ramsing, Andreasen, Lene Nyhus, Walsh, Simon, Kajander, Olli A., Witt, Nils, Eek, Christian, Knaapen, Paul, Koltowski, Lukasz, Gutiérrez-Chico, Juan Luis, Burzotta, Francesco, Kockman, Janusz, Ormiston, John, Santos-Pardo, Irene, Laanmets, Peep, Mylotte, Darren, Madsen, Morten, Hjort, Jakob, Kumsars, Indulis, Råmunddal, Truls, Christiansen, Evald Høj
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-11-2018 Elsevier Limited
Subjects:	Angina Angina pectoris Bifurcations Clinical outcomes Heart attacks Implantation Implants Intervention Ischemia Lesions Medical imaging Medicin och hälsovetenskap Mortality Myocardial infarction Optical Coherence Tomography Optimization Optimization techniques Patients Randomization Stenosis Stents Surgical implants Tomography
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23
ISSN:	0002-8703 1097-6744 1097-6744
DOI:	10.1016/j.ahj.2018.08.003