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Am Heart J. 2018 Nov;205:97-109. doi: 10.1016/j.ahj.2018.08.003. Epub 2018 Aug 16.

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

Author information

1
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. Electronic address: niels.holm@clin.au.dk.
2
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
3
Department of Cardiology, Belfast Health and Social Care Trust, Belfast, Northern Ireland.
4
Heart Centre, Department of Cardiology, Tampere University Hospital, Tampere, Finland and Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.
5
Department of Clinical Science and Education, Karolinska Institute, Unit of Cardiology, Södersjukhuset, Stockholm, Sweden.
6
Department of Cardiology, Oslo University Hospital, Oslo, Norway.
7
Department of Cardiology, VU University Medical Center, Amsterdam, the Netherlands.
8
Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
9
Department of Cardiology, Punta de Europa University Hospital, Algeciras, Spain.
10
Institute of Cardiology, F.Policlinico Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
11
Intra - Image Guided Healthcare, Auckland, New Zealand.
12
Cardiology Center, North Estonia Medical Center, Tallinn, Estonia.
13
Department of Cardiology, Galway University Hospital, Galway, Ireland.
14
Department of Clinical Epidemiology, Aarhus University Hospital, Skejby, Denmark.
15
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
16
Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia.

Abstract

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.

Implications:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03171311.

PMID:
30205242
DOI:
10.1016/j.ahj.2018.08.003
[Indexed for MEDLINE]
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