Management of Coronary Disease in Patients with Advanced Kidney Disease
Authors: Zhen Huang
Daniel B Mark
Harmony R Reynolds
Gregg W Stone
Judith S Hochman
Sripal Bangalore
ISCHEMIA-CKD Research Group
Ziad A Ali
Radoslaw Pracon
John A Spertus
Upendra Kaul
Charles A Herzog
Olga Bockeria
Sean M O&#x27;Brien
Bernard R Chaitman
Jerome L Fleg
Karen P Alexander
Carlo Briguori
Jeffrey S Berger
Tomasz Mazurek
David J Maron
William E Boden
Samuel Broderick
Roy O Mathew
Mandeep S Sidhu
Glenn M Chertow
Jonathan D Newman
Evgeny I Kretov
Journal: New England Journal of Medicine (2020)
Discipline: CLINICAL MEDICINE
Keywords: Clinical trials; revascularization; stable coronary disease; advanced chronic kidney disease; ischemia
Affiliations: 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.)., 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...

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 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.). 

Retracted: No

PubPeer comments:
 ### ISCHEMIA-CKD: No advantage of an early invasive strategy in CKD, CCS and stress-induced myocardial ischemia For patients with advanced chronic kidney disease (CKD) there was little data on the effect of cardiac revascularization in chronic coronary syndrome (CCS) due to common exclusion criteria. In the ISCHEMIA-CKD study, 777 patients with advanced CKD, CCS and moderate to severe myocardial ischemia under stress testing were randomized into two groups. One group followed an initial invasive strategy (coronary angiography and possibly revascularisation) including drug therapy, the other group followed a conservative strategy with drug therapy only. Patients in the conservative group received coronary angiography only if drug therapy was not successful. The primary, combined endpoint was defined as death or non-fatal heart attack. The secondary, combined endpoint included additional hospitalization due to unstable angina pectoris, heart failure or cardiac arrest. After 2.2 years of median observation time, the primary endpoint occurred in 123 patients in the invasive group versus 129 patients in the conservative group. This represents an estimated 3-year event rate of 36.4% vs. 36.7% (adjusted HR 1.01; 95% CI, 0.79-1.29; p = 0.95). Similarly, the event rate for the secondary endpoint was 38.5% vs. 39.7% (HR 1.01; 95% CI, 0.79-1.29). The invasive strategy showed higher rates of stroke (HR 3.76; 95% CI, 1.52-9.32; p = 0.004) and death and dialysis (HR 1.48; 95% CI, 1.04-2.11; p = 0.03). In summary, patients with advanced CKD, CCS and moderate to severe ischemia under stress testing showed no benefit from an early invasive therapy strategy. Conservative drug therapy alone was not associated with an increased risk of death or non-fatal myocardial infarction. ,