Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism (PEITHO)

Systemic thrombolysis is established for massive PE (hemodynamic instability). PEITHO tested whether thrombolysis benefits intermediate-risk (submassive) PE — RV dysfunction + troponin elevation but hemodynamically stable.

Multicenter RCT (76 centers, 13 countries, n=1,006) comparing tenecteplase + heparin vs. placebo + heparin in intermediate-risk PE.

Tenecteplase reduced the composite of death or hemodynamic decompensation (2.6% vs 5.6%, p=0.02). However, major extracranial bleeding was significantly higher (6.3% vs 1.5%) and stroke (2.4% vs 0.2%, p=0.003).

Systemic thrombolysis in submassive PE reduces hemodynamic decompensation but significantly increases major bleeding and stroke. Thrombolysis is NOT routinely recommended for submassive PE. Reserve for patients who deteriorate hemodynamically. Catheter-directed thrombolysis (CDT) is an alternative with lower bleeding risk.

Composite endpoint driven by hemodynamic decompensation (not mortality). Tenecteplase dose not weight-adjusted in all patients.