• Ziad A Ali, Ulf Landmesser, Akiko Maehara, Mitsuaki Matsumura, Richard A Shlofmitz, Giulio Guagliumi, Matthew J Price, Jonathan M Hill, Takashi Akasaka, Francesco Prati, Hiram G Bezerra, William Wijns, David Leistner, Paolo Canova, Fernando Alfonso, Franco Fabbiocchi, Ozgen Dogan, Robert J McGreevy, Robert W McNutt, Hong Nie, Jana Buccola, WestNick E JNEJFrom St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena, Gregg W Stone, and ILUMIEN IV Investigators.
• From St. Francis Hospital, Roslyn (Z.A.A., R.A.S.), Clinical Trials Center, Cardiovascular Research Foundation, New York (Z.A.A., A.M., M.M.), the Center for Interventional Cardiovascular Care, Columbia University (A.M., O.D.), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.), New York, and New York Institute of Technology, Glen Head (Z.A.A.) - all in New York; the Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Charité-Universitätsmedizin Berlin (U.L., D.L.), Berlin Institute of Health (U.L.), and Deutsches Zentrum für Herz-Kreislaufforschung (DZHK), Partner Site Berlin (U.L.), Berlin, and the Department of Medicine, Cardiology, Goethe University Hospital, and DZHK Partner Site Rhein-Main, Frankfurt (D.L.) - all in Germany; IRCCS Galeazzi Sant'Ambrogio Hospital (G.G.) and IRCCS Centro Cardiologico Monzino (F.F.), Milan, Saint Camillus International University of Health Sciences and Centro per la Lotta contro l'Infarto, Rome (F.P.), and Ospedale Papa Giovanni XXIII, Bergamo (P.C.) - all in Italy; the Division of Cardiovascular Diseases, Scripps Clinic, La Jolla (M.J.P.), and Abbott Vascular, Santa Clara (R.J.M., R.W.M., H.N., J.B., N.E.J.W.) - both in California; Royal Brompton Hospital, London (J.M.H.); Wakayama Medical University, Wakayama, Japan (T.A.); Tampa General Hospital, Tampa, FL (H.G.B.); the Lambe Institute for Translational Medicine and Cúram, University of Galway, Galway, Ireland (W.W.); and the Department of Cardiology, Hospital Universitario de la Princesa, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid (F.A.).
• N. Engl. J. Med. 2023 Oct 19; 389 (16): 146614761466-1476.

BackgroundData regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.MethodsIn this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.ResultsThe trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.ConclusionsAmong patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).Copyright © 2023 Massachusetts Medical Society.

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