RCT

PEITHO

Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism

NEJM, 2014 · Multicenter randomized double-blind placebo-controlled trial (n=1006)

Clinical question

Does systemic thrombolysis with tenecteplase improve outcomes in intermediate-risk (submassive) pulmonary embolism?

Population: Normotensive patients with acute PE, RV dysfunction on echo/CT, and elevated troponin
Intervention: Single IV bolus Tenecteplase plus Unfractionated Heparin
Comparator: Placebo plus Unfractionated Heparin
Primary outcome: All-cause mortality or hemodynamic collapse within 7 days
Result: Tenecteplase reduced the primary composite outcome (2.6% vs 5.6%, P=0.02) but significantly increased major extracranial bleeding (6.3% vs 1.2%, P<0.001) and hemorrhagic stroke (2.0% vs 0.2%, P=0.003).

What the trial found

Routine thrombolysis prevents hemodynamic decompensation but markedly increases major hemorrhage and hemorrhagic stroke.

Current guideline position

Class III for routine thrombolysis; Class I for rescue in ESC guidelines.

Clinical interpretation

Routine thrombolysis is withheld in submassive PE; close monitoring with rescue thrombolysis if shock develops is the standard of care.

Clinical Context & Relevant Topics (2)

Disease Reference

Acute Pulmonary Embolism

Pulmonary vascular occlusion, acute RV pressure overload, ESC/AHA risk stratification, systemic thrombolysis, catheter-directed therapies, and hemodynamic support.

View Topic Context →

Obstructive Shock

Extracardiac mechanical barriers to filling or ejection: Massive PE, Cardiac Tamponade, Tension Pneumothorax, and Auto-PEEP.

View Topic Context →