Overview
- HI-PEITHO, presented Saturday at the ACC meeting and published in NEJM, showed 4% vs 10.3% for the 30‑day composite outcome with catheter thrombolysis plus anticoagulation vs anticoagulation alone.
- The benefit came from fewer episodes of cardiorespiratory decompensation or collapse, with fewer patients needing rescue therapy.
- Major bleeding did not differ significantly between groups and no intracranial hemorrhages were reported in either arm within 30 days.
- The trial enrolled 544 adults with intermediate‑risk PE and signs of cardiorespiratory distress and used a low 9‑mg alteplase dose delivered by the EKOS ultrasound catheter system.
- Experts said the data could influence care for this specific patient group, though generalizability to other devices is uncertain, longer‑term outcomes to 6 and 12 months are pending, and the study had industry support.