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

Publication date: Available online 16 August 2018Source: American Heart JournalAuthor(s): Niels Ramsing Holm, Lene Nyhus Andreasen, Simon Walsh, Olli A. Kajander, Nils Witt, Christian Eek, Paul Knaapen, Lukasz Koltowski, Juan Luis Gutiérrez-Chico, Francesco Burzotta, Janusz Kockman, John Ormiston, Irene Santos-Pardo, Peep Laanmets, Darren Mylotte, Morten Madsen, Jakob Hjort, Indulis Kumsars, Truls Råmunddal, Evald Høj ChristiansenBackgroundPercutaneous coronary intervention (PCI) 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 designOCTOBER is a randomized, investigator initiated, multi-center 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 two-year composite endpoint of cardiac death, target lesion myocardial infarction, and ischemia driven target lesion revascularization. The calculated sample size is 1200 patients in total and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized NSTEMI, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter...
Source: American Heart Journal - Category: Cardiology Source Type: research