Two RCTs (n=357) were included.
Both of the included studies reported using adequate methods of randomisation and concealment and intention-to-treat analysis. One study was open label; the other study was reported as double-blinded, but became open label if participants had clinical deterioration requiring escalation of therapy. Both studies reported that the participants were similar at baseline, and reported cointerventions. Both studies also had complete follow-up.
There were no statistically significant differences in mortality between participants treated with thrombolytic therapy and participants in the control groups. One study (n=256) reported the death of 4 of the 118 participants in the thrombolytic group compared with 3 of the 138 in the control group (RR 1.56, 95% CI: 0.36, 6.83). The subgroup analysis of one study (n=46) reported no deaths in 23 patients in the thrombolytic group compared with the death of 2 of the 23 patients in the control group (RR 0.20, 95% CI: 0.01, 3.95).
There were no statistically significant differences in recurrence of PE between participants treated with thrombolytic therapy and participants in the control groups. One study reported that 4 of the 118 participants in the thrombolytic group compared with 4 of the138 in the control group had recurrent PE (RR 1.17, 95% CI: 0.30, 4.57). In the subgroup analysis of the second study, no participants in the thrombolytic group experienced recurrent PE compared with 5 of the 23 participants in the control group (RR 0.09, 95% CI: 0.01, 1.55). This included the 2 patients who died in the control group.
There were no statistically significant differences between groups for occurrence of major haemorrhage. One of the 118 patients in the thrombolytic group and 5 of the 138 patients in the control group had a major haemorrhage (RR 0.23, 95% CI: 0.03, 1.97). The subgroup analysis in the other study showed that one of the 23 patients in the control group experienced a major haemorrhage. This was a patient who had been inappropriately enrolled after head trauma.