Eike Nagel1, John P Greenwood1, Gerry P McCann1, Nuno Bettencourt1, Ajay M Shah1, Shazia T Hussain1, Divaka Perera1, Sven Plein1, Chiara Bucciarelli-Ducci1, Matthias Paul1, Mark A Westwood1, Michael Marber1, Wolf-Stefan Richter1, Valentina O Puntmann1, Carsten Schwenke1, Jeanette Schulz-Menger1, Rajiv Das1, Joyce Wong1, Derek J Hausenloy1, Henning Steen1, Colin Berry1. 1. From the Institute for Experimental and Translational Cardiovascular Imaging, DZHK (German Center for Cardiovascular Research) Center for Cardiovascular Imaging, Goethe University, and the Department of Cardiology, University Hospital Frankfurt, Frankfurt am Main (E.N., V.O.P.), Pharmtrace (W.-S.R.), Schwenke Consulting (C.S.), and Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health, DZHK, and Helios Kliniken Berlin-Buch (J.S.-M.), Berlin, and the Clinic for Cardiology, Angiology, and Pulmonology, University Hospital Heidelberg, Heidelberg (H.S.) - all in Germany; the Division of Biomedical Engineering and Imaging Sciences (E.N., S.T.H., S.P., M.P.) and British Heart Foundation Centre (A.M.S., D.P., M.M.), King's College London, Barts Heart Centre, St. Bartholomew's Hospital (M.A.W.), the Hatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London (D.J.H.), and the National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre (D.J.H.), London, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds (J.P.G., S.P.), the Department of Cardiovascular Sciences, University of Leicester and the NIHR Leicester Biomedical Research Centre, Glenfield Hospital (G.P.M.), and the Department of Cardiology, Glenfield Hospital (S.T.H.), Leicester, Bristol Heart Institute, University of Bristol and Bristol NIHR Biomedical Research Centre, Bristol (C.B.-D.), the Faculty of Health and Life Sciences, Northumbria University, and Freeman Hospital, Newcastle-upon-Tyne (R.D.), the Department of Cardiology, Royal Brompton and Harefield NHS Foundation Trust, Harefield Hospital, Uxbridge (J.W.), and the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow (C.B.) - all in the United Kingdom; Cardiovascular Research and Development Unit, Faculty of Medicine, University of Porto, Porto, Portugal (N.B.); Kardiologie, Herzzentrum Luzern, Luzerner Kantonsspital, Lucerne, Switzerland (M.P.); and the Cardiovascular and Metabolic Disorders Program, Duke-National University of Singapore Medical School, and the National Heart Research Institute Singapore, National Heart Center, Yong Loo Lin School of Medicine, National University of Singapore, Singapore (D.J.H.).
Abstract
BACKGROUND: In patients with stable angina, two strategies are often used to guide revascularization: one involves myocardial-perfusion cardiovascular magnetic resonance imaging (MRI), and the other involves invasive angiography and measurement of fractional flow reserve (FFR). Whether a cardiovascular MRI-based strategy is noninferior to an FFR-based strategy with respect to major adverse cardiac events has not been established. METHODS: We performed an unblinded, multicenter, clinical-effectiveness trial by randomly assigning 918 patients with typical angina and either two or more cardiovascular risk factors or a positive exercise treadmill test to a cardiovascular MRI-based strategy or an FFR-based strategy. Revascularization was recommended for patients in the cardiovascular-MRI group with ischemia in at least 6% of the myocardium or in the FFR group with an FFR of 0.8 or less. The composite primary outcome was death, nonfatal myocardial infarction, or target-vessel revascularization within 1 year. The noninferiority margin was a risk difference of 6 percentage points. RESULTS: A total of 184 of 454 patients (40.5%) in the cardiovascular-MRI group and 213 of 464 patients (45.9%) in the FFR group met criteria to recommend revascularization (P = 0.11). Fewer patients in the cardiovascular-MRI group than in the FFR group underwent index revascularization (162 [35.7%] vs. 209 [45.0%], P = 0.005). The primary outcome occurred in 15 of 421 patients (3.6%) in the cardiovascular-MRI group and 16 of 430 patients (3.7%) in the FFR group (risk difference, -0.2 percentage points; 95% confidence interval, -2.7 to 2.4), findings that met the noninferiority threshold. The percentage of patients free from angina at 12 months did not differ significantly between the two groups (49.2% in the cardiovascular-MRI group and 43.8% in the FFR group, P = 0.21). CONCLUSIONS: Among patients with stable angina and risk factors for coronary artery disease, myocardial-perfusion cardiovascular MRI was associated with a lower incidence of coronary revascularization than FFR and was noninferior to FFR with respect to major adverse cardiac events. (Funded by the Guy's and St. Thomas' Biomedical Research Centre of the National Institute for Health Research and others; MR-INFORM ClinicalTrials.gov number, NCT01236807.).
BACKGROUND: In patients with stable angina, two strategies are often used to guide revascularization: one involves myocardial-perfusion cardiovascular magnetic resonance imaging (MRI), and the other involves invasive angiography and measurement of fractional flow reserve (FFR). Whether a cardiovascular MRI-based strategy is noninferior to an FFR-based strategy with respect to major adverse cardiac events has not been established. METHODS: We performed an unblinded, multicenter, clinical-effectiveness trial by randomly assigning 918 patients with typical angina and either two or more cardiovascular risk factors or a positive exercise treadmill test to a cardiovascular MRI-based strategy or an FFR-based strategy. Revascularization was recommended for patients in the cardiovascular-MRI group with ischemia in at least 6% of the myocardium or in the FFR group with an FFR of 0.8 or less. The composite primary outcome was death, nonfatal myocardial infarction, or target-vessel revascularization within 1 year. The noninferiority margin was a risk difference of 6 percentage points. RESULTS: A total of 184 of 454 patients (40.5%) in the cardiovascular-MRI group and 213 of 464 patients (45.9%) in the FFR group met criteria to recommend revascularization (P = 0.11). Fewer patients in the cardiovascular-MRI group than in the FFR group underwent index revascularization (162 [35.7%] vs. 209 [45.0%], P = 0.005). The primary outcome occurred in 15 of 421 patients (3.6%) in the cardiovascular-MRI group and 16 of 430 patients (3.7%) in the FFR group (risk difference, -0.2 percentage points; 95% confidence interval, -2.7 to 2.4), findings that met the noninferiority threshold. The percentage of patients free from angina at 12 months did not differ significantly between the two groups (49.2% in the cardiovascular-MRI group and 43.8% in the FFR group, P = 0.21). CONCLUSIONS: Among patients with stable angina and risk factors for coronary artery disease, myocardial-perfusion cardiovascular MRI was associated with a lower incidence of coronary revascularization than FFR and was noninferior to FFR with respect to major adverse cardiac events. (Funded by the Guy's and St. Thomas' Biomedical Research Centre of the National Institute for Health Research and others; MR-INFORM ClinicalTrials.gov number, NCT01236807.).
Authors: Daniel E Forman; James A de Lemos; Leslee J Shaw; David B Reuben; Radmila Lyubarova; Eric D Peterson; John A Spertus; Susan Zieman; Marcel E Salive; Michael W Rich Journal: J Am Coll Cardiol Date: 2020-09-29 Impact factor: 24.094
Authors: Hans R Figulla; Alexander Lauten; Lars S Maier; Udo Sechtem; Sigmund Silber; Holger Thiele Journal: Dtsch Arztebl Int Date: 2020-02-28 Impact factor: 5.594
Authors: Panagiotis Antiochos; Yin Ge; Kevin Steel; Scott Bingham; Shuaib Abdullah; J Ronald Mikolich; Andrew E Arai; W Patricia Bandettini; Amit R Patel; Afshin Farzaneh-Far; John F Heitner; Chetan Shenoy; Steve W Leung; Jorge A Gonzalez; Dipan J Shah; Subha V Raman; Victor A Ferrari; Jeanette Schulz-Menger; Matthias Stuber; Orlando P Simonetti; Raymond Y Kwong Journal: J Am Coll Cardiol Date: 2020-08-25 Impact factor: 24.094