• N. Engl. J. Med. · Oct 2023

    Randomized Controlled Trial Multicenter Study Comparative Study

    OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

    • 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, H EekChristianCFrom the Department of Cardiology, Aarhus University Hospital, Aarhus (N.R.H., L.N.A., O.N., S.-H.B.R., L.J.H.M., M.S.L., E.H.C.), the Department of Cardiology, Gentofte Hospital, Gentofte (N.T.O., A.T.K.), the Department of Cardiology, Zea, 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, and OCTOBER Trial Group.
    • From the Department of Cardiology, Aarhus University Hospital, Aarhus (N.R.H., L.N.A., O.N., S.-H.B.R., L.J.H.M., M.S.L., E.H.C.), the Department of Cardiology, Gentofte Hospital, Gentofte (N.T.O., A.T.K.), the Department of Cardiology, Zealand University Hospital, Roskilde (O.H.), the Department of Cardiology, Rigshospitalet, Copenhagen (J.L.), the Department of Cardiology, Odense University Hospital, Odense (L.O.J.), and the Department of Cardiology, Aalborg University Hospital, Aalborg (A.E.) - all in Denmark; the Department of Cardiology, North Estonia Medical Center, Tallinn, Estonia (P.L.); Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia (I.K.); the Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven (J.B.), and the Department of Cardiology, Ziekenhuis Oost-Limburg, Genk (J.D.) - both in Belgium; the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (J.O.), the Department of Cardiology, Karolinska University Hospital (L.H.), and the Department of Clinical Science and Education, Karolinska Institute, Unit of Cardiology, Södersjukhuset (N.W., I.S.-P.), Stockholm, and the Department of Cardiology, Örebro University Hospital, Örebro (F.C.) - all in Sweden; the Department of Cardiology, Oslo University Hospital, Ullevål (P.H.), the Department of Cardiology, Trondheim University Hospital, Trondheim (M.H.), the Department of Cardiology, Oslo University Hospital, Oslo (C.E.), and the Department of Cardiology, Sørlandet Sykehus Arendal, Arendal (S. Calic) - all in Norway; the Department of Cardiology, Manchester Academic Health Science Centre, Wythenshawe Hospital, Manchester (S. Chowdhary), the Department of Cardiology, Royal Bournemouth Hospital, Bournemouth (P.O.), the Department of Cardiology, Golden Jubilee Hospital, Glasgow (S.W.), the Department of Cardiology, Sussex Cardiac Centre, Brighton (J.C.), the Department of Cardiology, Belfast Health and Social Care Trust, Belfast (A.M.), and Cardiology Care Group, St. George's University Hospitals NHS Foundation Trust and Cardiovascular Clinical Academic Group, St. George's University of London, London (J.C.S.) - all in the United Kingdom; the Department of Cardiology, St. Antonius Ziekenhaus, Nieuwegein (J.P.V.K.), the Department of Cardiology, Amsterdam UMC, Amsterdam (P.K.), and the Department of Cardiology, Northwest Hospital Alkmaar, Alkmaar (T.H.) - all in the Netherlands; Azienda Ospedaliero-Universitaria di Ferrara, Cardiology Unit, Ferrara (S.B.), and the Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome (F.B.) - both in Italy; the Department of Cardiology, University Hospital Galway, Galway, Ireland (D.M.); 1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland (L.K.); Tampere Heart Hospital, Tampere University Hospital, Tampere, Finland (O.A.K.); and Vivantes Klinikum im Friedrichshain, Berlin (S.K.).
    • N. Engl. J. Med. 2023 Oct 19; 389 (16): 147714871477-1487.

    BackgroundImaging-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.MethodsWe 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.ResultsWe 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.ConclusionsAmong 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.).Copyright © 2023 Massachusetts Medical Society.

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