Background: Whether patients presenting with mild stroke should or should not be treated with intravenous rtPA is still controversial. This systematic review aims to assess the safety and outcome of thrombolysis in these patients. Material/Methods: We systematically searched PubMed and Cochrane Central Register of Controlled Trials for studies evaluating intravenous rtPA in patients with mild or rapidly improving symptoms except case reports. Excellent outcome (author reported, mainly mRS 0-1), symptomatic intracranial hemorrhage (sICH) and mortality were analyzed. Results: Fourteen studies were included (n=1906 patients). Of these, 4 studies were comparative (2 randomized and 2 non-randomized). The remaining were single-arm studies. On the basis of 4 comparative studies with a total of 1006 patients, the meta-analysis did not identify a significant difference in the odds of excellent outcome (OR=0.86; 95% CI: 0.64–1.15; I2=0) between IV rtPA-treated minor stroke and those without rtPA treatment. Eleven studies involving 1083 patients showed the pooled rate of excellent outcome was 76.1% (95% CI: 69.8–81.5%, I2=42.5). Seven studies involving 378 patients showed the mortality rate was 4.5% (95% CI: 2.6–7.5%, I2=1.4). Twelve studies involving 831 patients showed the pooled rate of sICH was 2.4% (95% CI: 1.5–3.8, I2=0). Conclusions: Although efficacy is not clearly established, this study reveals the adverse event rates related to thrombolysis are low in mild stroke. Intravenous rtPA should be considered in these patients until more RCT evidence is available.

Keywords: Stroke - drug therapy, Thrombolytic Therapy