title: One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care] Trial).
abstract: The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) settings showed 80% reduction in infarct size at 30 days, suggesting potential longer-term benefits. Here we report 1-year outcomes. Prespecified 1-year end points of this randomized, placebo-controlled, double-blind, effectiveness trial included all-cause mortality and composites including cardiac arrest, mortality, or hospitalization for heart failure (HF). Of 871 participants randomized to GIK versus placebo, death occurred within 1 year in 11.6% versus 13.5%, respectively (unadjusted hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.57 to 1.23, p = 0.36). The composite of cardiac arrest or 1-year mortality was 12.8% versus 17.0% (HR 0.71, 95% CI 0.50 to 1.02, p = 0.06). The composite of hospitalization for HF or mortality within 1 year was 17.2% versus 17.2% (HR 0.98, 95% CI 0.70 to 1.37, p = 0.92). The composite of mortality, cardiac arrest, or HF hospitalization within 1 year was 18.1% versus 20.4% (HR 0.85, 95% CI 0.62 to 1.16, p = 0.30). In patients presenting with suspected ST elevation myocardial infarction, HRs for 1-year mortality and the 3 composites were, respectively, 0.65 (95% CI 0.33 to 1.27, p = 0.21), 0.52 (95% CI 0.30 to 0.92, p = 0.03), 0.63 (95% CI 0.35 to 1.16, p = 0.14), and 0.51 (95% CI 0.30 to 0.87, p = 0.01). In patients with suspected acute coronary syndromes, serious end points generally were lower with GIK than placebo, but the differences were not statistically significant. However, in those with ST elevation myocardial infarction, the composites of cardiac arrest or 1-year mortality, and of cardiac arrest, mortality, or HF hospitalization within 1 year, were significantly reduced.
authors.affiliation: Center for Cardiovascular Health Services Research, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts. Electronic address: hselker@tuftsmedicalcenter.org.
authors.forename: Harry P
authors.initials: HP
authors.lastname: Selker
authors.affiliation: Division of Cardiology and the CardioVascular Center, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: James E
authors.initials: JE
authors.lastname: Udelson
authors.affiliation: Department of Biostatistics, Boston University School of Medicine, Boston, Massachusetts.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.affiliation: Center for Cardiovascular Health Services Research, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Robin
authors.initials: R
authors.lastname: Ruthazer
authors.affiliation: Department of Mathematics and Statistics, Boston University, Boston, Massachusetts.
authors.forename: Ralph B
authors.initials: RB
authors.lastname: D'Agostino
authors.affiliation: Bouvé College of Health Sciences, Northeastern University, Boston, Massachusetts.
authors.forename: John L
authors.initials: JL
authors.lastname: Griffith
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Sheehan
authors.affiliation: National Institutes of Health, National Heart, Lung and Blood Institute, Bethesda, Maryland.
authors.forename: Patrice
authors.initials: P
authors.lastname: Desvigne-Nickens
authors.affiliation: National Institutes of Health, National Heart, Lung and Blood Institute, Bethesda, Maryland.
authors.forename: Yves
authors.initials: Y
authors.lastname: Rosenberg
authors.affiliation: National Institutes of Health, National Heart, Lung and Blood Institute, Bethesda, Maryland.
authors.forename: Xin
authors.initials: X
authors.lastname: Tian
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Vickery
authors.affiliation: Department of Medicine, University of Texas Southwestern Medical School, Dallas, Texas.
authors.forename: James M
authors.initials: JM
authors.lastname: Atkins
authors.affiliation: Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Tom P
authors.initials: TP
authors.lastname: Aufderheide
authors.affiliation: Department of Emergency Medicine, Cambridge Health Alliance, Cambridge, Massachusetts.
authors.forename: Assaad J
authors.initials: AJ
authors.lastname: Sayah
authors.affiliation: Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Ronald G
authors.initials: RG
authors.lastname: Pirrallo
authors.affiliation: Alaska Regional Hospital, Department of Emergency Medicine, Anchorage, Alaska.
authors.forename: Michael K
authors.initials: MK
authors.lastname: Levy
authors.affiliation: Department of Emergency Medicine, University of New Mexico Health Sciences Center, University of New Mexico School of Medicine, Albuquerque, New Mexico.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Richards
authors.affiliation: Department of Emergency Medicine, University of New Mexico Health Sciences Center, University of New Mexico School of Medicine, Albuquerque, New Mexico; Department of Anesthesiology, University of New Mexico Health Sciences Center, University of New Mexico School of Medicine, Albuquerque, New Mexico.
authors.forename: Darren A
authors.initials: DA
authors.lastname: Braude
authors.affiliation: Department of Emergency Medicine, Medical Center of Central Georgia, Macon, Georgia.
authors.forename: Delanor D
authors.initials: DD
authors.lastname: Doyle
authors.affiliation: Regions Hospital Emergency Medical Services, St. Paul, Minnesota.
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: Frascone
authors.affiliation: Avera Medical Group, Sioux Falls, South Dakota.
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Kosiak
authors.affiliation: Department of Emergency Medicine, Penn State Hershey Medical Center, Hershey, Pennsylvania.
authors.forename: James M
authors.initials: JM
authors.lastname: Leaming
authors.affiliation: Department of Emergency Medicine, Johnson Memorial Hospital, Stafford, Connecticut; Department of Emergency Medicine, Windham Community Memorial Hospital, Willimantic, Connecticut.
authors.forename: Carin M
authors.initials: CM
authors.lastname: Van Gelder
authors.affiliation: Department of Emergency Medicine, Emerson Hospital, Concord, Massachusetts.
authors.forename: Gert-Paul
authors.initials: GP
authors.lastname: Walter
authors.affiliation: Department of Emergency Medicine, Peace Health St. Joseph Medical Center, Bellingham, Washington.
authors.forename: Marvin A
authors.initials: MA
authors.lastname: Wayne
authors.affiliation: Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, Texas.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Woolard
authors.affiliation: Center for Cardiovascular Health Services Research, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Joni R
authors.initials: JR
authors.lastname: Beshansky
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D039602:After-Hours Care / Q000379:methods*; D002314:Cardioplegic Solutions; D002423:Cause of Death / Q000639:trends; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D005947:Glucose / Q000008:administration & dosage; D006323:Heart Arrest / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D007262:Infusions, Intravenous; D007328:Insulin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000378:metabolism; D010045:Outpatients; D011188:Potassium / Q000008:administration & dosage; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D002314:Cardioplegic Solutions; D007328:Insulin; C030396:glucose-insulin-potassium cardioplegic solution; D005947:Glucose; D011188:Potassium