Key result
Tenecteplase did not significantly affect short-term mortality (RR 0.83) in patients with intermediate-risk pulmonary embolism, but significantly increased the risk of major bleeding (RR 1.79).
Why the study?
The efficacy and safety of tenecteplase in patients with pulmonary embolism needed to be assessed.
Does tenecteplase improve survival and reduce hemodynamic failure compared to anticoagulation in patients with pulmonary embolism?
Meta-Analysis (n=2,201)
Does tenecteplase improve survival and reduce hemodynamic failure compared to anticoagulation in patients with pulmonary embolism?
Tenecteplase improves 30-day survival in high-risk PE without excess bleeding, but its use in intermediate-risk PE is limited by a significantly increased risk of major hemorrhage.
Does not support routine tenecteplase in intermediate-risk PE; reinforces anticoagulation alone given bleeding risk without mortality benefit.
Objective: To assess the efficacy and safety of tenecteplase in patients with pulmonary embolism (PE). Methods: We completed the literature search on May 31, 2021 using PubMed, EMBASE and the Web of Science. Analyses were conducted according to PE risk stratification, study design and duration of follow-up. The pooled risk ratios (RRs) and its 95% confident intervals (CIs) for death and major bleeding were calculated using a random-effect model. Results: A total of six studies, with four randomized controlled trials (RCTs) and two cohort studies, were included in this study out of the 160 studies retrieved. For patients with high-risk PE, tenecteplase increased 30-day survival rate (16% vs 6%; P = 0.005) and did not increase the incidence of bleeding (6% vs 5%; P = 0.73). For patients with intermediate-risk PE, four RCTs suggested that tenecteplase reduced right ventricular insufficiency at 24h early in the onset and the incidence of hemodynamic failure without affecting mortality in a short/long-term [<30 days RR = 0.83, 95% CI (0.47, 1.46);≥30 days RR = 1.04, 95% CI (0.88, 1.22)]. However, tenecteplase was associated with high bleeding risk [<30 days RR = 1.79, 95% CI (1.61, 2.00); ≥30 days RR = 1.28, 95% CI (0.62, 2.64)]. Conclusions: Tenecteplase may represent a promising candidate for patients with high risk PE. However, tenecteplase is not recommended for patients with intermediate-risk PE because of high bleeding risk. More large-scale studies focused on tenecteplase are still needed for PE patients.
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Zhang et al. (2022) conducted a meta-analysis in Pulmonary embolism (n=2,201). Tenecteplase vs. Anticoagulation therapy (Heparin, LMWH) or no fibrinolysis was evaluated on All-cause mortality at <30 days (intermediate-risk PE) (RR 0.83, 95% CI 0.47-1.46). Tenecteplase did not significantly affect short-term mortality (RR 0.83) in patients with intermediate-risk pulmonary embolism, but significantly increased the risk of major bleeding (RR 1.79).
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