title: Diabetic retinopathy should not be a contraindication to thrombolytic therapy for acute myocardial infarction: review of ocular hemorrhage incidence and location in the GUSTO-I trial. Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries.
abstract: OBJECTIVE
  This study sought to evaluate the incidence of ocular hemorrhage in patients with and without diabetes after thrombolytic therapy for acute myocardial infarction.
  
  
  BACKGROUND
  Ocular hemorrhage after thrombolysis has been reported rarely. However, there is concern that the risk is increased in patients with diabetes. In fact, diabetic hemorrhagic retinopathy has been identified as a contraindication to thrombolytic therapy without clear evidence that these patients have an increased risk for ocular hemorrhage.
  
  
  METHODS
  We identified all suspected ocular hemorrhages from bleeding complications reported in patients enrolled in the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO)-I trial. Additional information was collected on a one-page data form. We compared the incidence and location of ocular hemorrhages in patients with and without diabetes.
  
  
  RESULTS
  There were 40,899 patients (99.7%) with information about diabetic history and ocular bleeding. Twelve patients (0.03%) had an ocular hemorrhage. Intraocular hemorrhage was confirmed in only one patient. There were 6,011 patients (15%) with diabetes, of whom only 1 had an ocular hemorrhage (eyelid hematoma after a documented fall). The upper 95% confidence intervals for the incidence of intraocular hemorrhage in patients with and without diabetes were 0.05% and 0.006%, respectively.
  
  
  CONCLUSIONS
  Ocular hemorrhage and, more important, intraocular hemorrhage after thrombolytic therapy for acute myocardial infarction is extremely uncommon. The calculated upper 95% confidence interval for the incidence of intraocular hemorrhage in patients with diabetes was only 0.05%. We conclude that diabetic retinopathy should not be considered a contraindication to thrombolysis in patients with an acute myocardial infarction.
authors.affiliation: Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA. mahaf002@mc.duke.edu
authors.forename: K W
authors.initials: KW
authors.lastname: Mahaffey
authors.forename: C B
authors.initials: CB
authors.lastname: Granger
authors.forename: C A
authors.initials: CA
authors.lastname: Toth
authors.forename: H D
authors.initials: HD
authors.lastname: White
authors.forename: A L
authors.initials: AL
authors.lastname: Stebbins
authors.forename: G I
authors.initials: GI
authors.lastname: Barbash
authors.forename: A
authors.initials: A
authors.lastname: Vahanian
authors.forename: E J
authors.initials: EJ
authors.lastname: Topol
authors.forename: R M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D000368:Aged; D000075202:Contraindications; D003930:Diabetic Retinopathy / Q000150:complications* / Q000453:epidemiology; D005130:Eye Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy*; D012307:Risk Factors; D013300:Streptokinase / Q000627:therapeutic use; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use
chemical_list: D005343:Fibrinolytic Agents; D006493:Heparin; D013300:Streptokinase; D010959:Tissue Plasminogen Activator