title: Factors associated with intracerebral hemorrhage after thrombolytic therapy for ischemic stroke: pooled analysis of placebo data from the Stroke-Acute Ischemic NXY Treatment (SAINT) I and SAINT II Trials.
abstract: OBJECTIVE
  A number of factors have been associated with postthrombolysis intracerebral hemorrhage, but these have varied across studies.
  
  
  METHODS
  We examined patients with acute ischemic stroke treated with intravenous tissue plasminogen activator within 3 hours of symptom onset who were enrolled in the placebo arms of 2 trials (Stroke-Acute Ischemic NXY Treatment [SAINT] I and II Trials) of a putative neuroprotectant. Early CT changes were graded using the Alberta Stroke Program Early CT Score (ASPECTS). Post-tissue plasminogen activator symptomatic intracerebral hemorrhage was defined as a worsening in National Institutes of Health Stroke Scale of > or =4 points within 36 hours with evidence of hemorrhage on follow-up neuroimaging. Good clinical outcome was defined as a modified Rankin scale of 0 to 2 at 90 days.
  
  
  RESULTS
  Symptomatic intracerebral hemorrhage occurred in 5.6% of 965 patients treated with tissue plasminogen activator. In multivariable analysis, symptomatic intracerebral hemorrhage was increased with baseline antiplatelet use (single antiplatelet: OR, 2.04, 95% CI, 1.07 to 3.87, P=0.03; double antiplatelet: OR, 9.29, 3.28 to 26.32, P<0.001), higher National Institutes of Health Stroke Scale score (OR, 1.09 per point, 1.03 to 1.15, P=0.002), and CT changes defined by ASPECTS (ASPECTS 8 to 9: OR, 2.26, 0.63 to 8.10, P=0.21; ASPECTS < or =7: OR, 5.63, 1.66 to 19.10, P=0.006). Higher National Institutes of Health Stroke Scale was associated with decreased odds of good clinical outcome (OR, 0.82 per point, 0.79 to 0.85, P<0.001). There was no relationship between baseline antiplatelet use or CT changes and clinical outcome.
  
  
  CONCLUSIONS
  Along with higher National Institutes of Health Stroke Scale and extensive early CT changes, baseline antiplatelet use (particularly double antiplatelet therapy) was associated with an increased risk of post-tissue plasminogen activator symptomatic intracerebral hemorrhage. Of these factors, only National Institutes of Health Stroke Scale was associated with clinical outcome.
authors.affiliation: Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. cucchiar@mail.med.upenn.edu
authors.forename: Brett
authors.initials: B
authors.lastname: Cucchiara
authors.forename: Scott E
authors.initials: SE
authors.lastname: Kasner
authors.forename: David
authors.initials: D
authors.lastname: Tanne
authors.forename: Steven R
authors.initials: SR
authors.lastname: Levine
authors.forename: Andrew
authors.initials: A
authors.lastname: Demchuk
authors.forename: Steven R
authors.initials: SR
authors.lastname: Messe
authors.forename: Lauren
authors.initials: L
authors.lastname: Sansing
authors.forename: Kennedy R
authors.initials: KR
authors.lastname: Lees
authors.forename: Patrick
authors.initials: P
authors.lastname: Lyden
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000175:diagnosis / Q000188:drug therapy*; D002543:Cerebral Hemorrhage / Q000139:chemically induced* / Q000175:diagnosis; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator