OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

Abstract

BACKGROUND:

Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.

METHODS:

We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.

RESULTS:

We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.

CONCLUSIONS:

Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

• Authors: Niels R Holm, Lene N Andreasen, Omeed Neghabat, Peep Laanmets, Indulis Kumsars, Johan Bennett, Niels T Olsen, Jacob Odenstedt, Pavel Hoffmann, Jo Dens, Saqib Chowdhary, Peter O'Kane, Søren-Haldur Bülow Rasmussen, Matthias Heigert, Ole Havndrup, Jan P Van Kuijk, Simone Biscaglia, Lone J H Mogensen, Loghman Henareh, Francesco Burzotta, Christian H Eek, Darren Mylotte, Miquel S Llinas, Lukasz Koltowski, Paul Knaapen, Slobodan Calic, Nils Witt, Irene Santos-Pardo, Stuart Watkins, Jacob Lønborg, Andreas T Kristensen, Lisette O Jensen, Fredrik Calais, James Cockburn, Andrew McNeice, Olli A Kajander, Ton Heestermans, Stephan Kische, Ashkan Eftekhari, James C Spratt, Evald H Christiansen, OCTOBER Trial Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 389 Issue 16 Pg. 1477-1487 (Oct 19 2023) ISSN: 1533-4406 [Electronic] United States
• PMID: 37634149 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2023 Massachusetts Medical Society.

Topics

• Humans
• Coronary Angiography (adverse effects, methods)
• Coronary Artery Disease (diagnostic imaging, therapy)
• Percutaneous Coronary Intervention (adverse effects, methods)
• Tomography, Optical Coherence (adverse effects, methods)
• Treatment Outcome
• Europe