title: Risk factors for stroke after acute coronary syndromes in the Orbofiban in Patients with Unstable Coronary Syndromes--Thrombolysis In Myocardial Infarction (OPUS-TIMI) 16 study.
abstract: BACKGROUND
  Previous reports have associated acute coronary syndromes (ACSs) with cerebrovascular disease but in general have not included long-term patient follow-up or have not analyzed ischemic and hemorrhagic cerebrovascular events separately.
  
  
  METHODS
  We analyzed stroke outcomes from the OPUS-TIMI 16 study, a multicenter, randomized, placebo-controlled trial. Patients were randomized to aspirin plus either orbofiban or placebo and followed for up to 1 year. Cerebrovascular events were prospectively identified and classified by a committee of cardiologists and neurologists blinded to treatment assignment.
  
  
  RESULTS
  During 10 months of follow-up, there were 150 (1.5%) patients with cerebrovascular events. Risk factors for ischemic stroke (n = 67) and transient ischemic attack (TIA) (n = 44) were age, prior ischemic stroke, history of hypertension, and increased heart rate. Prior ischemic stroke and history of hypertension were not risk factors for 30-day ischemic stroke or TIA. Risk factors for intracranial hemorrhage (ICH) (n = 14) were age, history of hypertension, history of TIA, and coronary angiography with evidence of coronary artery disease. Compared with placebo, treatment with orbofiban was associated with a nonsignificant increased risk of ischemic stroke or TIA (HR 1.15, 95% CI 0.76-1.74, P = .51) and ICH (HR 1.25, 95% CI 0.39-4.00, P = .70).
  
  
  CONCLUSIONS
  The overall incidence of cerebrovascular events after ACS was highest in the first 30 days then declined; risk factors for cerebrovascular events may be different in the different periods. Orbofiban, despite no significant excess risk of ICH, was not effective in preventing ischemic stroke or TIA.
authors.affiliation: Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA. eesmith@partners.org
authors.forename: Eric E
authors.initials: EE
authors.lastname: Smith
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Cannon
authors.forename: Sabina
authors.initials: S
authors.lastname: Murphy
authors.forename: Steven K
authors.initials: SK
authors.lastname: Feske
authors.forename: Lee H
authors.initials: LH
authors.lastname: Schwamm
mesh_terms: D000368:Aged; D000409:Alanine / Q000627:therapeutic use; D000789:Angina, Unstable / Q000150:complications*; D001241:Aspirin / Q000627:therapeutic use; D002543:Cerebral Hemorrhage / Q000209:etiology* / Q000401:mortality; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology* / Q000401:mortality / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000150:complications*; D016016:Proportional Hazards Models; D011759:Pyrrolidines / Q000627:therapeutic use; D012307:Risk Factors; D020521:Stroke / Q000209:etiology* / Q000401:mortality / Q000517:prevention & control; D013577:Syndrome; D015912:Thrombolytic Therapy
chemical_list: D005343:Fibrinolytic Agents; D011759:Pyrrolidines; C120234:orbofiban; D000409:Alanine; D001241:Aspirin