Udo Hoffmann1, Maros Ferencik2, James E Udelson2, Michael H Picard2, Quynh A Truong2, Manesh R Patel2, Megan Huang2, Michael Pencina2, Daniel B Mark2, John F Heitner2, Christopher B Fordyce2, Patricia A Pellikka2, Jean-Claude Tardif2, Matthew Budoff2, George Nahhas2, Benjamin Chow2, Andrzej S Kosinski2, Kerry L Lee2, Pamela S Douglas2. 1. From Massachusetts General Hospital, Harvard Medical School, Boston (U.H., M.H.P.); Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.F.); Tufts University School of Medicine and the CardioVascular Center, Tufts Medical Center, Boston, MA (J.E.U.); Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medical College (Q.A.T.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.R.P., M.H., M.P., D.B.M., C.B.F., A.S.K., K.L.L., P.S.D.); Cardiovascular Research, New York Methodist Hospital, Brooklyn (J.F.H.); Mayo Clinic, Rochester, MN (P.A.P.); Montreal Heart Institute, Université de Montréal, Canada (J.-C.T.); Los Angeles Biomedical Research Institute, Torrance, CA (M.B.); Cardiology, Beaumont Hospital-Dearborn, MI (G.N.); and Department of Medicine, Ottawa Heart Institute, Ontario, Canada (B.C.). uhoffmann@mgh.harvard.edu. 2. From Massachusetts General Hospital, Harvard Medical School, Boston (U.H., M.H.P.); Knight Cardiovascular Institute, Oregon Health and Science University, Portland (M.F.); Tufts University School of Medicine and the CardioVascular Center, Tufts Medical Center, Boston, MA (J.E.U.); Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital and Weill Cornell Medical College (Q.A.T.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.R.P., M.H., M.P., D.B.M., C.B.F., A.S.K., K.L.L., P.S.D.); Cardiovascular Research, New York Methodist Hospital, Brooklyn (J.F.H.); Mayo Clinic, Rochester, MN (P.A.P.); Montreal Heart Institute, Université de Montréal, Canada (J.-C.T.); Los Angeles Biomedical Research Institute, Torrance, CA (M.B.); Cardiology, Beaumont Hospital-Dearborn, MI (G.N.); and Department of Medicine, Ottawa Heart Institute, Ontario, Canada (B.C.).
Abstract
BACKGROUND: Optimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing. METHODS: In the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain and intermediate pretest probability for obstructive coronary artery disease (CAD) were randomly assigned to functional testing (exercise electrocardiography, nuclear stress, or stress echocardiography) or coronary computed tomography angiography (CTA). Site-based diagnostic test reports were classified as normal or mildly, moderately, or severely abnormal. The primary end point was death, myocardial infarction, or unstable angina hospitalizations over a median follow-up of 26.1 months. RESULTS: Both the prevalence of normal test results and incidence rate of events in these patients were significantly lower among 4500 patients randomly assigned to CTA in comparison with 4602 patients randomly assigned to functional testing (33.4% versus 78.0%, and 0.9% versus 2.1%, respectively; both P<0.001). In CTA, 54.0% of events (n=74/137) occurred in patients with nonobstructive CAD (1%-69% stenosis). Prevalence of obstructive CAD and myocardial ischemia was low (11.9% versus 12.7%, respectively), with both findings having similar prognostic value (hazard ratio, 3.74; 95% confidence interval [CI], 2.60-5.39; and 3.47; 95% CI, 2.42-4.99). When test findings were stratified as mildly, moderately, or severely abnormal, hazard ratios for events in comparison with normal tests increased proportionally for CTA (2.94, 7.67, 10.13; all P<0.001) but not for corresponding functional testing categories (0.94 [P=0.87], 2.65 [P=0.001], 3.88 [P<0.001]). The discriminatory ability of CTA in predicting events was significantly better than functional testing (c-index, 0.72; 95% CI, 0.68-0.76 versus 0.64; 95% CI, 0.59-0.69; P=0.04). If 2714 patients with at least anintermediate Framingham Risk Score (>10%) who had a normal functional test were reclassified as being mildly abnormal, the discriminatory capacity improved to 0.69 (95% CI, 0.64-0.74). CONCLUSIONS: Coronary CTA, by identifying patients at risk because of nonobstructive CAD, provides better prognostic information than functional testing in contemporary patients who have stable chest pain with a low burden of obstructive CAD, myocardial ischemia, and events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01174550.
RCT Entities:
BACKGROUND: Optimal management of patients with stable chest pain relies on the prognostic information provided by noninvasive cardiovascular testing, but there are limited data from randomized trials comparing anatomic with functional testing. METHODS: In the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain and intermediate pretest probability for obstructive coronary artery disease (CAD) were randomly assigned to functional testing (exercise electrocardiography, nuclear stress, or stress echocardiography) or coronary computed tomography angiography (CTA). Site-based diagnostic test reports were classified as normal or mildly, moderately, or severely abnormal. The primary end point was death, myocardial infarction, or unstable angina hospitalizations over a median follow-up of 26.1 months. RESULTS: Both the prevalence of normal test results and incidence rate of events in these patients were significantly lower among 4500 patients randomly assigned to CTA in comparison with 4602 patients randomly assigned to functional testing (33.4% versus 78.0%, and 0.9% versus 2.1%, respectively; both P<0.001). In CTA, 54.0% of events (n=74/137) occurred in patients with nonobstructive CAD (1%-69% stenosis). Prevalence of obstructive CAD and myocardial ischemia was low (11.9% versus 12.7%, respectively), with both findings having similar prognostic value (hazard ratio, 3.74; 95% confidence interval [CI], 2.60-5.39; and 3.47; 95% CI, 2.42-4.99). When test findings were stratified as mildly, moderately, or severely abnormal, hazard ratios for events in comparison with normal tests increased proportionally for CTA (2.94, 7.67, 10.13; all P<0.001) but not for corresponding functional testing categories (0.94 [P=0.87], 2.65 [P=0.001], 3.88 [P<0.001]). The discriminatory ability of CTA in predicting events was significantly better than functional testing (c-index, 0.72; 95% CI, 0.68-0.76 versus 0.64; 95% CI, 0.59-0.69; P=0.04). If 2714 patients with at least an intermediate Framingham Risk Score (>10%) who had a normal functional test were reclassified as being mildly abnormal, the discriminatory capacity improved to 0.69 (95% CI, 0.64-0.74). CONCLUSIONS: Coronary CTA, by identifying patients at risk because of nonobstructive CAD, provides better prognostic information than functional testing in contemporary patients who have stable chest pain with a low burden of obstructive CAD, myocardial ischemia, and events. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01174550.
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