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.
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.
Smith
Eric E
EE
Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA. eesmith@partners.org
Cannon
Christopher P
CP
Murphy
Sabina
S
Feske
Steven K
SK
Schwamm
Lee H
LH
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
D005343:Fibrinolytic Agents; D011759:Pyrrolidines; C120234:orbofiban; D000409:Alanine; D001241:Aspirin