Andrew E Arai1, Jeanette Schulz-Menger2, Daniel Berman3, Heiko Mahrholdt4, Yuchi Han5, W Patricia Bandettini6, Matthias Gutberlet7, Arun Abraham8, Pamela K Woodard9, Joseph B Selvanayagam10, Gerry P McCann11, Christian Hamilton-Craig12, U Joseph Schoepf13, Ru San Tan14, Christopher M Kramer15, Matthias G Friedrich16, Daniel Haverstock17, Zheyu Liu17, Guenther Brueggenwerth18, Claudia Bacher-Stier18, Marta Santiuste17, Dudley J Pennell19. 1. National Heart, Lung, and Blood Institute, National Institutes of Health, DHHS, Bethesda, Maryland. Electronic address: araia@nih.gov. 2. Helios Klinikum Berlin Buch Klinik für Kardiologie und Nephrologie Abteilung Kardio-MRT, Berlin, Germany. 3. Cedar-Sinai Medical Center, Los Angeles, California. 4. Robert-Bosch-Krankenhaus Zentrum für Innere Medizin (ZIM) III Abteilung für Kardiologie, Stuttgart, Germany. 5. Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania. 6. National Heart, Lung, and Blood Institute, National Institutes of Health, DHHS, Bethesda, Maryland. 7. Herzzentrum Leipzig Abteilung für Diagnostische und Interventionelle Radiologie, Leipzig, Germany. 8. Royal Perth Hospital, Perth, Western Australia, Australia. 9. Washington University School of Medicine, St. Louis, Missouri. 10. Flinders University, Flinders Medical Centre, Adelaide, South Australia, Australia. 11. Department of Cardiovascular Sciences University of Leicester and the NIHR Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, United Kingdom. 12. The Prince Charles Hospital Cardiology Research Centre, Brisbane, Queensland, Australia. 13. Medical University of South Carolina, Charleston, South Carolina. 14. National Heart Centre Singapore, Singapore. 15. University of Virginia Health System, Charlottesville, Virginia. 16. Departments of Medicine and Diagnostic Radiology, McGill University Health Centre, Montreal, Quebec, Canada. 17. Bayer Pharmaceuticals LLC, Whippany, New Jersey. 18. Bayer AG, Berlin, Germany. 19. Cardiovascular Research Centre and CMR Unit at Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom; National Heart and Lung Institute, Imperial College, London, United Kingdom.
Abstract
BACKGROUND: Gadolinium-based contrast agents were not approved in the United States for detecting coronary artery disease (CAD) prior to the current studies. OBJECTIVES: The purpose of this study was to determine the sensitivity and specificity of gadobutrol for detection of CAD by assessing myocardial perfusion and late gadolinium enhancement (LGE) imaging. METHODS: Two international, single-vendor, phase 3 clinical trials of near identical design, "GadaCAD1" and "GadaCAD2," were performed. Cardiovascular magnetic resonance (CMR) included gadobutrol-enhanced first-pass vasodilator stress and rest perfusion followed by LGE imaging. CAD was defined by quantitative coronary angiography (QCA) but computed tomography coronary angiography could exclude significant CAD. RESULTS: Because the design and results for GadaCAD1 (n = 376) and GadaCAD2 (n = 388) were very similar, results were summarized as a fixed-effect meta-analysis (n = 764). The prevalence of CAD was 27.8% defined by a ≥70% QCA stenosis. For detection of a ≥70% QCA stenosis, the sensitivity of CMR was 78.9%, specificity was 86.8%, and area under the curve was 0.871. The sensitivity and specificity for multivessel CAD was 87.4% and 73.0%. For detection of a 50% QCA stenosis, sensitivity was 64.6% and specificity was 86.6%. The optimal threshold for detecting CAD was a ≥67% QCA stenosis in GadaCAD1 and ≥63% QCA stenosis in GadaCAD2. CONCLUSIONS: Vasodilator stress and rest myocardial perfusion CMR and LGE imaging had high diagnostic accuracy for CAD in 2 phase 3 clinical trials. These findings supported the U.S. Food and Drug Administration approval of gadobutrol-enhanced CMR (0.1 mmol/kg) to assess myocardial perfusion and LGE in adult patients with known or suspected CAD. Published by Elsevier Inc.
BACKGROUND:Gadolinium-based contrast agents were not approved in the United States for detecting coronary artery disease (CAD) prior to the current studies. OBJECTIVES: The purpose of this study was to determine the sensitivity and specificity of gadobutrol for detection of CAD by assessing myocardial perfusion and late gadolinium enhancement (LGE) imaging. METHODS: Two international, single-vendor, phase 3 clinical trials of near identical design, "GadaCAD1" and "GadaCAD2," were performed. Cardiovascular magnetic resonance (CMR) included gadobutrol-enhanced first-pass vasodilator stress and rest perfusion followed by LGE imaging. CAD was defined by quantitative coronary angiography (QCA) but computed tomography coronary angiography could exclude significant CAD. RESULTS: Because the design and results for GadaCAD1 (n = 376) and GadaCAD2 (n = 388) were very similar, results were summarized as a fixed-effect meta-analysis (n = 764). The prevalence of CAD was 27.8% defined by a ≥70% QCA stenosis. For detection of a ≥70% QCA stenosis, the sensitivity of CMR was 78.9%, specificity was 86.8%, and area under the curve was 0.871. The sensitivity and specificity for multivessel CAD was 87.4% and 73.0%. For detection of a 50% QCA stenosis, sensitivity was 64.6% and specificity was 86.6%. The optimal threshold for detecting CAD was a ≥67% QCA stenosis in GadaCAD1 and ≥63% QCA stenosis in GadaCAD2. CONCLUSIONS: Vasodilator stress and rest myocardial perfusion CMR and LGE imaging had high diagnostic accuracy for CAD in 2 phase 3 clinical trials. These findings supported the U.S. Food and Drug Administration approval of gadobutrol-enhanced CMR (0.1 mmol/kg) to assess myocardial perfusion and LGE in adult patients with known or suspected CAD. Published by Elsevier Inc.
Authors: Amit R Patel; Michael Salerno; Raymond Y Kwong; Amita Singh; Bobak Heydari; Christopher M Kramer Journal: J Am Coll Cardiol Date: 2021-10-19 Impact factor: 27.203
Authors: Roel S Driessen; Pepijn A van Diemen; Pieter G Raijmakers; Juhani Knuuti; Teemu Maaniitty; S Richard Underwood; Eike Nagel; Lourens F H J Robbers; Ahmet Demirkiran; Martin B von Bartheld; Peter M van de Ven; Leonard Hofstra; G Aernout Somsen; Igor I Tulevski; Ronald Boellaard; Albert C van Rossum; Ibrahim Danad; Paul Knaapen Journal: Eur Heart J Date: 2022-09-01 Impact factor: 35.855