Penumbra (PEN) said Monday that 90-day results from the STORM-PE randomized controlled trial showed patients with acute intermediate-high risk pulmonary embolism treated with computer-assisted vacuum thrombectomy, or CAVT, plus anticoagulation achieved greater functional improvement than those receiving anticoagulation alone.
Patients in the CAVT plus anticoagulation arm walked farther in the six-minute walk test, averaging 479 meters compared with 368 meters and reached 94% of their predicted walking distance versus 75.2% for those on anticoagulation alone. A higher proportion of patients also reported no physical limitations based on the New York Heart Association functional class scale, at 97% versus 76%.
Safety outcomes through 90 days were comparable across both groups, with no device-related mortality, no additional pulmonary embolism-related deaths beyond seven days, and no difference in symptomatic recurrence.
The data were presented at the Society of Interventional Radiology Annual Scientific Meeting. Penumbra said interim Strike-PE data on long-term quality of life and functional outcomes in CAVT-treated patients will be presented at the same meeting on April 15.
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