Catheter-Directed Therapy Bests Anticoagulation in Intermediate-Risk PE

In the HI-PEITHO trial, ultrasound-facilitated catheter-directed fibrinolysis plus anticoagulation cut the risk of PE-related death, cardiorespiratory decompensation, or recurrence by 61% at 7 days compared with anticoagulation alone in acute intermediate-risk PE. The benefit was driven mainly by fewer cases of decompensation or collapse, without excess bleeding. Results were presented at ACC.26 and published in NEJM.

Key results

The trial randomized 544 patients from 59 sites with confirmed intermediate-risk PE, defined by RV dysfunction, elevated troponin, and signs of cardiorespiratory distress. Intervention patients received EkoSonic thrombolysis (mean alteplase dose 8-17 mg) plus heparin within 2 hours. The primary composite endpoint at 7 days was 4.0% vs 10.3% (RR 0.4; P=0.005), with a number needed to treat of 16.

Safety profile

No significant differences emerged in major bleeding by ISTH or GUSTO criteria at 72 hours, 7 days, or 30 days, and there were no intracranial bleeds. All-cause mortality was low and similar at 30 days (1.8% intervention vs 1.1% control). Escalation to rescue therapy was also less frequent in the intervention arm.

Clinical implications

Experts said the results support catheter-directed therapy for select intermediate-high-risk patients, like those in category D of the 2026 PE guidelines (incipient failure with hypotension or normotensive shock). Caution is advised against broad extrapolation beyond this enriched cohort, which excluded many screened patients. The trial builds on PEITHO by showing efficacy with lower bleeding risk than systemic lysis.