Sripal Bangalore1, David J Maron1, Sean M O'Brien1, Jerome L Fleg1, Evgeny I Kretov1, Carlo Briguori1, Upendra Kaul1, Harmony R Reynolds1, Tomasz Mazurek1, Mandeep S Sidhu1, Jeffrey S Berger1, Roy O Mathew1, Olga Bockeria1, Samuel Broderick1, Radoslaw Pracon1, Charles A Herzog1, Zhen Huang1, Gregg W Stone1, William E Boden1, Jonathan D Newman1, Ziad A Ali1, Daniel B Mark1, John A Spertus1, Karen P Alexander1, Bernard R Chaitman1, Glenn M Chertow1, Judith S Hochman1. 1. From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), 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; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).
Abstract
BACKGROUND: Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease. METHODS: We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with aninitial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. RESULTS: At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03). CONCLUSIONS: Among patients with stable coronary disease, advanced chronic kidney 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 death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).
RCT Entities:
BACKGROUND: Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease. METHODS: We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. RESULTS: At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03). CONCLUSIONS: Among patients with stable coronary disease, advanced chronic kidney 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 death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).
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