- Question
- Does ultrasound-facilitated, catheter-directed fibrinolysis added to anticoagulation improve early clinical outcomes compared with anticoagulation alone in acute intermediate-risk pulmonary embolism?
- Design
- Multinational, randomized, adaptive-design trial with blinded outcome adjudication. The intention-to-treat population comprised 544 patients: 273 in the intervention group and 271 in the control group.
- Population
- Patients with acute intermediate-risk pulmonary embolism, with a right-to-left ventricular end-diastolic diameter ratio ≥1.0 and elevated troponin. They had to show at least two indicators of cardiorespiratory distress (systolic blood pressure ≤110 mm Hg, heart rate ≥100 beats per minute, or respiratory rate >20 breaths per minute). Mean age was 58.2 years and 42.6% were women.
- Intervention
- Ultrasound-facilitated, catheter-directed fibrinolysis with alteplase plus anticoagulation, according to prespecified treatment protocols.
- Control
- Anticoagulation alone, according to prespecified treatment protocols.
- Primary outcome
- Composite of pulmonary embolism-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days.
- Results
- A primary-outcome event occurred in 11 patients (4.0%) in the intervention group and 28 (10.3%) in the control group (relative risk, 0.39; 95% CI, 0.20 to 0.77; P = 0.005). The effect was driven primarily by a lower risk of cardiorespiratory decompensation or collapse with the intervention.
- Safety
- Major bleeding within 7 days occurred in 11 patients (4.1%) with the intervention and 6 (2.2%) with control (P = 0.32); within 30 days, in 11 (4.1%) and 8 (3.0%), respectively (P = 0.64). There was no intracranial hemorrhage and no substantial differences in other serious adverse events through 30 days.
- Conclusion
- In acute intermediate-risk pulmonary embolism, adding ultrasound-facilitated, catheter-directed fibrinolysis to anticoagulation lowered the 7-day composite of pulmonary embolism-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence compared with anticoagulation alone.
- Why it matters
- It provides randomized evidence that, in selected intermediate-risk pulmonary embolism patients with signs of cardiorespiratory distress, catheter-directed therapy can prevent early clinical deterioration, and it informs the debate on when to escalate beyond anticoagulation alone.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026