Safety of routine IV thrombolysis between 3 and 4.5 h after ischemic stroke.
BACKGROUND
The administration of tissue plasminogen activator (t-PA) has been proven effective for ischemic stroke within 3 h after onset. A pooled-analysis of six trials showed that intravenous t-PA still improves outcome when given between 3 to 4.5 h after stroke onset. On the basis of this pooled analysis, t-PA was also routinely offered to our patients between 3-4.5 h. We report the safety and clinical features of this group together with the features of the group given t-PA within 3 h.


METHODS
Prospectively patient characteristics, stroke severity, stroke subtype, incidence of symptomatic intracerebral hemorrhage (SICH), in-hospital mortality, and 3-months modified Rankin Scale scores (mRS) were registered. Data was analyzed separately for patients treated within 3 h (early group) and those treated between 3-4.5 h (late group).


RESULTS
Among 176 patients who underwent intravenous thrombolysis, 101 were treated in the early group and 75 in the late group. Six (5.9%; 95% CI 2.8%-12.3%) patients in the early group and 4 (5.3%; 95% CI 2.2%-12.9%) in the late group developed SICH (p=1.0). In the early group 13 (12.9%; 95% CI 7.7%-20.8%) patients died within 7 days after admission, compared to 5 (6.7%; 95% CI 3.0%-14.7%) in the late group (p=0.179). In the early group 44 (43.6%; 95% CI 43.3%-53.3%) were independent (mRS< or =2) at three months, compared to 36 (48.0%; 95% CI 37.0%-59.1%) in the late group (p=0.559).


CONCLUSIONS
Our data show no trend of decreased safety of thrombolysis beyond 3 h. Due to a small sample size a harmful effect cannot be excluded but seems unlikely.
Uyttenboogaart
M
M
Department of Neurology, University Medical Center Groningen, Hanzeplein 1, 9700 RB Groningen, The Netherlands. m.uyttenboogaart@neuro.umcg.nl
Vroomen
P C A J
PC
Stewart
R E
RE
De Keyser
J
J
Luijckx
G J
GJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D002543:Cerebral Hemorrhage / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000517:prevention & control; D004334:Drug Administration Schedule; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007275:Injections, Intravenous / Q000009:adverse effects; D008297:Male; D011237:Predictive Value of Tests; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000401:mortality / Q000592:standards*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D014057:Tomography, X-Ray Computed / Q000592:standards; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator