Eleven RCTs (n=3,709) were included in the review. Nine of the included studies were placebo-controlled and two used an active comparator. The duration of follow-up ranged from 1 to 12 months.
Thrombolytic therapy was associated with a non significant slight increase in mortality at the end of follow-up (OR 1.07, 95% CI: 0.8, 1.39, P=0.3; based on 11 RCTs). The absolute increased risk of mortality was 11 per 1,000 persons (95% CI: -24, 48, P=0.3) and the NNH was 84.
Similar results in mortality were shown when the analysis was based on thrombolytic therapy administered during the first month of therapy (OR 1.14, 95% CI: 0.75, 1.73, P=0.6; based on 9 RCTs), following the exclusion of ancrod studies (OR 1.13, 95% CI: 0.77, 1.68, P=0.2; based on 9 RCTs) and for studies of rt-PA therapy (OR 1.25, 95% CI: 0.87, 1.78, P=0.1; based on 7 RCTs). A non significant slight decrease in mortality was shown for rt-PA therapy administration within 3 hours (OR 0.98, 95% CI: 0.63, 1.53, P=0.8; based on 4 RCTs).
The funnel plots did not show any evidence of publication bias (data not reported).