Why the study?
While thrombolysis benefits massive pulmonary embolism, evidence supporting clinical outcome benefit in intermediate-risk pulmonary embolism is lacking.
Does thrombolytic therapy improve overall survival or reduce all-cause mortality in adult patients with intermediate-risk pulmonary embolism compared to anticoagulation alone?
Does thrombolytic therapy improve overall survival or reduce all-cause mortality in adult patients with intermediate-risk pulmonary embolism compared to anticoagulation alone?
In patients with intermediate-risk pulmonary embolism, systemic thrombolysis increases the risk of major bleeding without providing a statistically significant benefit in all-cause mortality compared to anticoagulation alone.
Thrombolysis increases major bleeding without reducing mortality in intermediate-risk PE; reinforces anticoagulation alone and leaves optimal selection open.
Background: Benefit of thrombolytic therapy in patients with massive pulmonary embolism (PE) is evident. However, evidence supporting benefit in clinical outcomes of this approach in intermediate risk PE is lacking. Objective: To determine the impact of thrombolysis on overall survival in intermediate risk PE patients. Methods: We searched in MEDLINE (OVID), EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials (CENTRAL) from present day. We also searched in other databases and unpublished literature. We included clinical trials without language restrictions. The risk of bias was evaluated with the Cochrane Collaboration's tool. The primary outcome was overall survival. Secondary outcomes were adverse events, including major bleeding, and all-cause mortality. The measure of the effect was the risk ratio with a 95% confidence interval (CI). Results: We included 11 studies in the qualitative and quantitative analysis, with a total of 1855 patients. Risk of bias was variable among the study items. There were no results reported about overall survival in any of the studies. The risk ratio (RR) for all-cause mortality was 0.68 95% CI (0.40 to 1.16). The RR of overall bleeding, major bleeding and stroke were 2.72 95% CI (1.58 to 4.69), 2.17 95% CI (1.03 to 4.55), and 2.22 95% CI (0.17 to 28.73), respectively. Additionally, the RR for recurrent PE was 0.56 95% CI (0.23 to 1.37). Conclusions: In patients with intermediate risk PE, the risk of bleeding is higher when thrombolysis is used. There was no significant difference between thrombolysis and anticoagulation in recurrence of PE, stroke, and all-cause mortality.
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Alcedo et al. (2020) studied this question.
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