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Publications

Journal Article Ahead of print 2 citations

PubMed: 41911017 DOI: 10.1056/NEJMoa2600440

IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease.

N Engl J Med

Authors: Luca Testa, Jose Maria De la Torre Hernandez, Giovanni Luigi De Maria, Daniel A Jones, Pablo Piñon-Esteban, Gianluca Campo, Bruno Garcia Del Blanco, Manuel Pan, Tamara Garcia-Camarero, Gennaro Sardella, Peter O'Kane, John P Greenwood, Flavio L Ribichini, Irene Pescetelli, Alfonso Ielasi, Iñigo Lozano, James Cockburn, Jacopo A Oreglia, Azfar G Zaman, Francesco Bedogni, Wietze Lindeboom, Jan G P Tijssen, Ernest Spitzer, Adrian P Banning

Affiliations

  • Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan.
  • Vita-Salute University-San Raffaele Hospital, Milan.
  • Department of Cardiology, Hospital Universitario Marques de Valdecilla, Instituto de Investigación Sanitaria de Valdecilla, Santander, Spain.
  • Oxford Heart Centre, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom.
  • Acute Multidisciplinary Imaging and Interventional Centre, University of Oxford, Oxford, United Kingdom.
  • Department of Cardiology, St. Bartholomew's Hospital, Barts Health NHS Trust, London.
  • Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London.
  • Department of Cardiology, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • Department of Cardiology, Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy.
  • Department of Cardiology, Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBER CV), Barcelona.
  • Department of Cardiology, Hospital Reina Sofia, University of Cordoba, Instituto Maimonides de Investigaciones Biomédicas de Córdoba, CIBER CV, Cordoba, Spain.
  • Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome.
  • Department of Cardiology, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
  • Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
  • Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.
  • Department of Medicine, Division of Cardiology, University of Verona, Verona, Italy.
  • Department of Cardiology, Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
  • Department of Cardiology, IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan.
  • Department of Cardiology, Hospital de Cabueñes, University of Oviedo, Gijon, Spain.
  • Department of Cardiology, Royal Sussex County Hospital, Brighton, United Kingdom.
  • Department of Cardiology, Niguarda Hospital, Milan.
  • Department of Cardiology, Freeman Hospital, Newcastle University, Newcastle, United Kingdom.
  • Cardialysis, Rotterdam, the Netherlands.
  • Department of Cardiology, Amsterdam University Medical Center, Amsterdam.
  • European Cardiovascular Research Institute, Rotterdam, the Netherlands.
  • National Institute for Health and Care Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, United Kingdom.

Abstract

BACKGROUND

Percutaneous coronary intervention (PCI) is increasingly used for revascularization of unprotected left main coronary artery disease. Whether intravascular ultrasonographic (IVUS) guidance during PCI results in better clinical outcomes than conventional angiographic guidance alone is uncertain.

METHODS

In an international, multicenter, open-label trial, we randomly assigned patients with unprotected left main coronary artery disease in a 1:1 ratio to undergo either IVUS-guided PCI or angiography-guided PCI. The primary end point was a patient-oriented composite of any stroke, any myocardial infarction, any revascularization, or death from any cause at the longest follow-up.

RESULTS

A total of 806 patients underwent randomization; 401 were assigned to undergo IVUS-guided PCI and 405 to undergo angiography-guided PCI. The mean (±SD) age of the patients was 71.4±10.7 years, 78.4% of the patients were men, and 34.7% had diabetes. At a median follow-up of 2.9 years, a primary end-point event had occurred in 135 patients (33.7%) in the IVUS-guided PCI group and in 125 patients (30.9%) in the angiography-guided PCI group (hazard ratio, 1.11; 95% confidence interval, 0.87 to 1.42; P = 0.40). The incidence of death, myocardial infarction, or revascularization appeared to be similar in the two groups. The percentages of patients with procedure-related and overall safety events also appeared to be similar in the two groups.

CONCLUSIONS

Among patients with unprotected left main coronary artery disease, IVUS-guided PCI showed no additional benefit over angiography-guided PCI with respect to the incidence of stroke, myocardial infarction, any revascularization, or death from any cause at a median follow-up of 2.9 years. (Funded by Philips Image Guided Therapy Devices and Boston Scientific; OPTIMAL ClinicalTrials.gov number, NCT04111770.).

MeSH

Stroke, Coronary Artery Disease, Myocardial Infarction, Incidence, Angiography, Arteries, Coronary Disease

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