HI-PEITHO: katheter-gestuurde trombolyse halveert ernstige uitkomsten bij intermediair-hoog-risico longembolie

Background: The role of catheter-directed therapy in intermediate-high-risk pulmonary embolism (PE) is unclear. Methods: In this multicenter, randomized, open-label trial conducted at 59 sites in the United States and Europe, we assigned patients with acute intermediate-high-risk PE to ultrasound-facilitated catheter-directed fibrinolysis (EKOS Endovascular System) plus anticoagulation or anticoagulation alone. The primary endpoint was a composite of PE-related death, cardiorespiratory decompensation or collapse, or symptomatic nonfatal PE recurrence within 7 days. Results: A total of 544 patients were enrolled (mean age 58.2 years, 42.6% women). The primary endpoint occurred in 10 of 270 patients (3.7%) in the catheter-directed fibrinolysis group and in 28 of 274 patients (10.3%) in the anticoagulation-alone group (relative risk, 0.4; 95% CI, 0.2-0.7; P=0.005), representing a 61% relative risk reduction. There was no intracranial bleeding in either group and no significant difference in major bleeding. At 30 days, mortality was 1.8% versus 1.1% (not significant). The mean alteplase dose was 8.85 mg for unilateral and 16.92 mg for bilateral catheter placement, with a mean infusion time of 7 hours. Conclusions: Among patients with acute intermediate-high-risk PE, ultrasound-facilitated catheter-directed fibrinolysis was superior to anticoagulation alone in reducing the composite of PE-related death, cardiorespiratory decompensation, or recurrent PE within 7 days.