Ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower 7-day risk of PE-related death, decompensation, or recurrence than anticoagulation alone.
RCT
Does ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation reduce the composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days in patients with acute, intermediate-risk pulmonary embolism?
In patients with acute, intermediate-risk pulmonary embolism, ultrasound-facilitated catheter-directed fibrinolysis plus anticoagulation reduces the short-term risk of adverse clinical outcomes compared to anticoagulation alone.
BACKGROUND: Whether anticoagulation alone is an adequate treatment for acute, intermediate-risk pulmonary embolism is uncertain. METHODS: We conducted a multinational, adaptive-design trial with blinded outcome adjudication. Patients with intermediate-risk pulmonary embolism (with a ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter of ≥1.0 and an elevated troponin level) were eligible if they had at least two indicators of cardiorespiratory distress (systolic blood pressure of ≤110 mm Hg, a heart rate of ≥100 beats per minute, or a respiratory rate of >20 breaths per minute). Patients were randomly assigned to undergo ultrasound-facilitated, catheter-directed fibrinolysis with alteplase plus anticoagulation (the intervention group) or anticoagulation alone (the control group) according to prespecified treatment protocols. The primary outcome was a composite of pulmonary embolism-related death, cardiorespiratory decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days. RESULTS: The intention-to-treat population comprised 544 patients: 273 in the intervention group and 271 in the control group. The mean (±SD) age was 58.2±13.5 years, and 42.6% of the patients were women. A primary-outcome event occurred in 11 patients (4.0%; 95% confidence interval CI, 2.3 to 7.1) in the intervention group and 28 (10.3%; 95% CI, 7.2 to 14.5) 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 in the intervention group. Major bleeding occurred within 7 days after randomization in 11 patients (4.1%) in the intervention group and 6 (2.2%) in the control group (P = 0.32); major bleeding occurred within 30 days in 11 patients (4.1%) and 8 patients (3.0%), respectively (P = 0.64). No substantial between-group differences in the incidence of other serious adverse events were observed up to 30 days after randomization; no intracranial hemorrhage occurred. CONCLUSIONS: In patients with acute, intermediate-risk pulmonary embolism, ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower risk of the composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days than anticoagulation alone. (Funded by Boston Scientific; HI-PEITHO ClinicalTrials.gov number, NCT04790370.).
“This trial shows that a catheter intervention can indeed be effective and improve the prognosis for patients with severe PE and elevated risk of early death or life-threatening complications. If the right patients are selected for this procedure, it can prevent patients from deteriorating and it can do so at an acceptably low risk of bleeding complications.”
Positive late-breaker at ACC.26 simultaneously published in NEJM; strong media coverage (10+ outlets) and interventional cardiology discussions; >400 X engagements; positions EKOS as superior for select PE patients with practice-changing potential.
Rosenfield et al. (Sat,) conducted a rct in Acute, intermediate-risk pulmonary embolism. Ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation vs. Anticoagulation alone was evaluated on Composite of pulmonary embolism-related death, cardiopulmonary decompensation or collapse, or symptomatic recurrence of pulmonary embolism within 7 days. Ultrasound-facilitated, catheter-directed fibrinolysis plus anticoagulation led to a lower 7-day risk of PE-related death, decompensation, or recurrence than anticoagulation alone.