Patients with intermediate-high risk pulmonary embolism have an elevated right-to-left ventricular diameter ratio and are at risk of early clinical decompensation and mortality. Reperfusion therapy aims to rapidly relieve acute right ventricular pressure overload and normalize hemodynamics. STORM-PE is the first reported randomized controlled trial to test the efficacy and evaluate the safety of mechanical thrombectomy, specifically computer-assisted vacuum thrombectomy with anticoagulation compared to anticoagulation alone.
STORM-PE is an international randomized controlled trial with 1:1 randomization to computer-assisted vacuum thrombectomy with anticoagulation or anticoagulation alone. Eligible adults had acute onset (symptoms ≤14 days), intermediate-high risk pulmonary embolism, and were normotensive, with a right-to-left ventricular ratio ≥1.0 on computed tomography pulmonary angiography and elevated cardiac biomarkers. The primary endpoint analysis tested for a difference between groups for the change in right-to-left ventricular ratio at 48 hours, assessed by a blinded independent imaging core laboratory. Secondary endpoints included major adverse events within 7 days (a composite of clinical deterioration necessitating rescue therapy, pulmonary embolism–related mortality, symptomatic recurrent pulmonary embolism, and major bleeding), adjudicated by an external clinical events committee. Additional outcomes included change in vital signs and core laboratory–assessed pulmonary artery obstruction at 48 hours. Results: A total of 100 patients enrolled across 22 sites were randomized to computer-assisted vacuum thrombectomy (N=47) or anticoagulation alone (N=53). Baseline characteristics were comparable between arms. At 48 hours, mean reduction in right-to-left ventricular ratio was greater for computer-assisted vacuum thrombectomy (0.52±0.37) than anticoagulation alone (0.24±0.40), a difference of 0.27 (95 percent confidence interval, 0.12, 0.43; P<0.001). Refined modified and modified Miller score exhibited greater changes for computer-assisted vacuum thrombectomy than anticoagulation at 48 hours (P<0.001). Early normalization of vital signs within 48 hours was more frequent after computer-assisted vacuum thrombectomy. The major adverse event rate within 7 days was not different between groups (computer-assisted vacuum thrombectomy 4.3 percent vs anticoagulation 7.5 percent, P=0.681). Two pulmonary embolism–related deaths occurred in the computer-assisted vacuum thrombectomy arm.
Computer-assisted vacuum thrombectomy was superior to anticoagulation alone in reducing right-to-left ventricular ratio within 48 hours in intermediate-high risk pulmonary embolism patients, accompanied by earlier normalization of vital signs and comparable major adverse event rates to anticoagulation.
Keywords:
Pulmonary embolism, Intermediate-high risk PE, Mechanical thrombectomy, Anticoagulation therapy, Catheter-based intervention, Randomized controlled trial, STORM-PE Trial, Acute PE management, Hemodynamic instability, Right ventricular dysfunction
Reference:
Lookstein, R. A., Konstantinides, S. V., Weinberg, I., Dohad, S. Y., Rosol, Z., Kopeć, G., Moriarty, J. M., and the STORM-PE Trial Investigators. (2025). Randomized controlled trial of mechanical thrombectomy with anticoagulation versus anticoagulation alone for acute intermediate-high risk pulmonary embolism: Primary outcomes from the STORM-PE Trial. Circulation. Advance online publication. https://doi.org/10.1161/CIRCULATIONAHA.125.077232
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