Population:
Inclusion: Ischemic stroke with clearly defined onset (within 3hrs), measurable deficit on NIHSS, CT showing no evidence of intracranial hemorrhage
Exclusion: blood pressure >185 systolic or >110 diastolic, rapidly improving or minor symptoms, symptoms suggestive of SAH, GI or GU hemorrhage withing 21 days, arterial puncture at noncompressible site within 7 days, had seizure at onset of stroke, heparin within 48 hrs, PT >15s, platelets <100k, glucose <50 or >400mg/dL, aggressive BP treatment required
Two part study:
Phase 1: 291 patients tested improvement in NIHSS (>4 from baseline) or resolution of deficits between groups
Phase 2: 333 patients. Measured clinical outcomes at 3 months
Intervention:
t-PA vs standard medical care
Results:
No significant difference in improvement in NIHSS at 24hrs between groups
Median NIHSS was significantly lower in TPA group at 3 months
1.7 Odds ratio for favorable outcome in TPA group (p=0.008)
12% more pts in TPA group had no or minimal disability at 3 months
No difference in mortality at 3 months
TPA group had more symptomatic ICH (8/144 vs 0/147)
Outcome:
TPA initiated within 3 hours of is beneficial in terms of clinical recovery for patients with ischemic stroke
Population:
Inclusion: 18-80 years old, clinical diagnosis of acute ischemic stroke, could receive alteplase within 3-4.5 hours of symptom onset, CT without evidence of hemorrhage, symptomatic
Exclusion: ICH, unknown symptom onset, rapidly improving symptoms, minor symptoms, NIHSS >25, seizure, TPA condraindications
n=821
Intervention:
0.9 mg/kg of alteplase vs placebo
CT or MRI before and 22-36 hours after treatment
Results:
Favorable outcome (Rankin 0-1) 52.4% in tPa group compared to 45.2% (P=0.04) at 90 days
Number needed to treat = 14 in 3-4.5hr window
Favorable outcome (ability to return to an independent lifestyle) Odds ratio 1.28 (P=0.05)
mRS 0-1: Odds ratio 1.34 (p=0.04)
Barthel Index Score >95: Odds ratio 1.23 (p=0.16)
NIHSS 0-1: Odds ratio 1.33 (p =0.04)
GOS 1: Odds ratio 1.25 (p=0.11)
No statistical differences in all cause mortality (7.7% vs 8.4%) or symptomatic edema (6.9% vs 7.2%)
ICH occurred more frequently in tPA group (27.0% vs 17.6% p=0.001). Symptomatic ICH also occurred more often (2.4% vs 0.3% p=0.008)
Outcome:
TPA given within 3-4.5 hrs is associated with a significant clinical improvement at 3 months and has similar rates of symptomatic intracranial hemorrhage compared to TPA given <3hrs
Higher incidence of symptomatic intracranial hemorrhage compared to standard of care
Number needed to treat = 14 in 3-4.5hr window