David J Maron1, Judith S Hochman1, Harmony R Reynolds1, Sripal Bangalore1, Sean M O'Brien1, William E Boden1, Bernard R Chaitman1, Roxy Senior1, Jose López-Sendón1, Karen P Alexander1, Renato D Lopes1, Leslee J Shaw1, Jeffrey S Berger1, Jonathan D Newman1, Mandeep S Sidhu1, Shaun G Goodman1, Witold Ruzyllo1, Gilbert Gosselin1, Aldo P Maggioni1, Harvey D White1, Balram Bhargava1, James K Min1, G B John Mancini1, Daniel S Berman1, Michael H Picard1, Raymond Y Kwong1, Ziad A Ali1, Daniel B Mark1, John A Spertus1, Mangalath N Krishnan1, Ahmed Elghamaz1, Nagaraja Moorthy1, Whady A Hueb1, Marcin Demkow1, Kreton Mavromatis1, Olga Bockeria1, Jesus Peteiro1, Todd D Miller1, Hanna Szwed1, Rolf Doerr1, Matyas Keltai1, Joseph B Selvanayagam1, P Gabriel Steg1, Claes Held1, Shun Kohsaka1, Stavroula Mavromichalis1, Ruth Kirby1, Neal O Jeffries1, Frank E Harrell1, Frank W Rockhold1, Samuel Broderick1, T Bruce Ferguson1, David O Williams1, Robert A Harrington1, Gregg W Stone1, Yves Rosenberg1. 1. From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).
Abstract
BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to aninitial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).
RCT Entities:
BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).
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