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

Francesco Burzotta, Niels Ramsing Holm, Lene Nyhus Andreasen, Simon Walsh, Olli A. Kajander, Nils Witt, Christian Eek, Paul Knaapen, Lukasz Koltowski, Juan Luis Gutiérrez-Chico, Janusz Kockman, John Ormiston, Irene Santos-Pardo, Peep Laanmets, Darren Mylotte, Morten Madsen, Jakob Hjort, Indulis Kumsars, Truls Råmunddal, Evald Høj Christiansen

Risultato della ricerca: Contributo in rivistaArticolo in rivista

10 Citazioni (Scopus)

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.
Lingua originaleEnglish
pagine (da-a)97-109
Numero di pagine13
RivistaAmerican Heart Journal
Volume205
DOI
Stato di pubblicazionePubblicato - 2018

Keywords

  • Aged
  • Coronary Angiography
  • Coronary Stenosis
  • Coronary Vessels
  • Drug-Eluting Stents
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention
  • Tomography, Optical Coherence
  • Treatment Outcome

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