Low-Versus Standard-Dose Alteplase for Ischemic Strokes Within 4.5 Hours
Aged, 80 and over
Male
Middle Aged
Severity of Illness Index
Brain Ischemia
3. Good health
Stroke
03 medical and health sciences
0302 clinical medicine
Fibrinolytic Agents
Tissue Plasminogen Activator
Outcome Assessment, Health Care
Humans
Female
Thrombolytic Therapy
Registries
Aged
DOI:
10.1161/strokeaha.115.010180
Publication Date:
2015-08-05T02:20:21Z
AUTHORS (27)
ABSTRACT
Background and Purpose—
The low-dose (0.6 mg/kg) alteplase strategy to treat acute ischemic stroke patients became widespread in East Asian countries, without rigorous testing against standard-dose (0.9 mg/kg) alteplase treatment. Our aim was to investigate the comparative effectiveness and safety of the low-dose versus standard-dose intravenous alteplase strategy.
Methods—
A total of 1526 acute ischemic stroke patients who qualified for intravenous alteplase and treated within 4.5 hours were identified from a prospective, multicenter, and nationwide stroke registry database. Primary outcomes were a modified Rankin scale score of 0 to 1 at 3 months after stroke and occurrence of symptomatic hemorrhagic transformation. Inverse probability of low-dose alteplase weighting by propensity scores was used to remove baseline imbalances between the 2 groups, and variation among centers were also accounted using generalized linear mixed models with a random intercept.
Results—
Low-dose intravenous alteplase was given to 450 patients (29.5%) and standard-dose intravenous alteplase to 1076 patients (70.5%). Low-dose alteplase treatment was comparable to standard-dose therapy according to the following adjusted outcomes and odds ratios (95% confidence intervals): modified Rankin scale score 0 to 1 at 3 months and 0.95 (0.68–1.32); modified Rankin scale 0 to 2 at 3 months and 0.84 (0.62–1.15); symptomatic hemorrhagic transformation and 1.05 (0.65–1.70); and 3-month mortality and 0.54 (0.35–0.83). The associations were unchanged when the analysis was limited to those without endovascular recanalization.
Conclusions—
The low-dose alteplase strategy was comparable to the standard-dose treatment in terms of the effectiveness and safety.
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