Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism.
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Rosenfield Kenneth, Klok Frederikus A, Piazza Gregory, Sharp Andrew S P, Ní Áinle Fionnuala, Jaff Michael R, Barco Stefano, Goldhaber Samuel Z, Kucher Nils, Lang Irene M, Schmidtmann Irene, Sterling Keith M, Araszkiewicz Aleksander, Arora Vishal, Cires-Drouet Rafael, Coghlan John, Hobohm Lukas, Ito Wulf D, Jacobson Kurt, Kaiser Christoph, Kopec Grzegorz, Marx Kristin, McElwee Samuel, Meneveau Nicolas, Monteleone Peter, Montero-Cabezas Jose M, Olivier Christoph B, Park John, Roik Marek, Sakhuja Rahul, Tego Andi, Theurl Markus, Visveswaran Gautam, Vos Jan Albert, Young Michael N, Asch Federico M, Konstantinides Stavros V, HI-PEITHO Investigators
Аннотация
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.).