title: Intensive glucose regulation in hyperglycemic acute coronary syndrome: results of the randomized BIOMarker study to identify the acute risk of a coronary syndrome-2 (BIOMArCS-2) glucose trial.
abstract: OBJECTIVE
  Elevated plasma glucose levels in patients with acute coronary syndrome (ACS) on hospital admission are associated with increased mortality. Clinical trials of glucose regulation have provided inconsistent results with respect to cardiovascular outcomes, perhaps because target glucose levels have been suboptimal.
  
  
  OBJECTIVE
  To study the effectiveness and safety of intensive glucose management in patients with ACS who have hyperglycemia, aiming at strict blood glucose normalization.
  
  
  METHODS
  Single-center, prospective, open-label, randomized clinical trial in a large teaching hospital. Patients with ACS with an admission plasma glucose level of 140 to 288 mg/dL were eligible for inclusion and enrolled from July 23, 2008, to February 8, 2012. Patients with insulin-dependent diabetes mellitus were excluded. Informed consent was obtained from 294 patients, who were randomized. Of these, 93.6% received percutaneous coronary intervention (PCI).
  
  
  METHODS
  Intensive glucose management strategy, aiming at a plasma glucose level of 85 to 110 mg/dL by using intravenous insulin, or to conventional expectative glucose management.
  
  
  METHODS
  End points were assessed according to the intention-to-treat principle. The primary end point was high-sensitivity troponin T value 72 hours after admission (hsTropT72); secondary end points, area under the curve of creatine kinase, myocardial band (AUC-CK-MB), release and myocardial perfusion scintigraphy findings at 6 weeks' follow-up.
  
  
  RESULTS
  In the intensive management arm, median hsTropT72 was 1197 ng/L (25th and 75th percentiles of distribution, 541-2296 ng/L) vs 1354 ng/L (530-3057 ng/L) in the conventional arm (P = .41). Median AUC-CK-MB was 2372 U/L (1242-5004 U/L) vs 3171 U/L (1620-5337 U/L) (P = .18). The difference in median extent of myocardial injury measured by myocardial perfusion scintigraphy was not significant (2% vs 4%) (P = .07). Severe hypoglycemia (<50 mg/dL) was rare and occurred in 13 patients. Before discharge, death or a spontaneous second myocardial infarction occurred in 8 patients (5.7%) vs 1 (0.7%) (P = .04). CONCLUSIONS AND RELEVANCE Intensive glucose regulation did not reduce infarct size in hyperglycemic patients with ACS treated with PCI, and was associated with harm. Future studies should focus on patients with ACS who have persistently elevated blood glucose after PCI, and should evaluate alternative strategies for optimizing glycemia.
  
  
  BACKGROUND
  www.trialregister.nl Identifier: NTR1205.
authors.affiliation: Department of Cardiology, Medical Center Alkmaar, Alkmaar, the Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: de Mulder
authors.forename: Victor A
authors.initials: VA
authors.lastname: Umans
authors.forename: Jan H
authors.initials: JH
authors.lastname: Cornel
authors.forename: Friso M
authors.initials: FM
authors.lastname: van der Zant
authors.forename: Frank
authors.initials: F
authors.lastname: Stam
authors.forename: Rohit M
authors.initials: RM
authors.lastname: Oemrawsingh
authors.forename: K Martijn
authors.initials: KM
authors.lastname: Akkerhuis
authors.forename: Eric
authors.initials: E
authors.lastname: Boersma
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications* / Q000473:pathology / Q000628:therapy; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects; D003402:Creatine Kinase / Q000097:blood; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000150:complications / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000473:pathology; D055414:Myocardial Perfusion Imaging; D009206:Myocardium / Q000473:pathology; D011446:Prospective Studies; D020107:Troponin T / Q000097:blood
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D020107:Troponin T; D003402:Creatine Kinase