New STORM-PE Data Shows Improved Functional Outcomes with CAVT Plus Anticoagulation

Patients with acute intermediate-high risk pulmonary embolism treated with computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation achieved greater functional improvement compared to anticoagulation alone.

Apr. 13, 2026 at 11:21pm

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A ghostly, translucent X-ray-style image showing the human heart and lungs, with the pulmonary arteries glowing brightly to represent the effects of a pulmonary embolism. The image conveys the serious clinical nature of the condition while hinting at the advanced medical technology used to treat it.An advanced medical imaging technique reveals the internal structures affected by a pulmonary embolism, informing new treatment approaches that can improve long-term patient recovery.Mount Sinai Today

The 90-day results of the STORM-PE randomized controlled trial (RCT) have demonstrated that patients with acute intermediate-high risk pulmonary embolism (PE) who were treated with computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation achieved greater functional improvement, including walking significantly further and a higher proportion of patients achieving New York Heart Association (NYHA) class I (no physical limitations), compared to anticoagulation alone.

Why it matters

The STORM-PE trial provides important clinical evidence supporting the role of endovascular therapy like CAVT beyond anticoagulation alone for the treatment of intermediate-high risk PE, which can help inform future clinical guidelines and improve patient outcomes and recovery.

The details

The STORM-PE RCT enrolled 100 patients across 22 international sites to evaluate CAVT using Penumbra's Lightning Flash device plus anticoagulation, versus anticoagulation alone, for the treatment of acute intermediate-high risk PE. At 90 days, patients treated with CAVT plus anticoagulation walked significantly longer distances during the six-minute walk test (479m vs. 368m; p=0.003) and a higher proportion achieved NYHA class I (no physical limitations) compared to anticoagulation only (97% vs. 76%, p=0.022). The safety profile of CAVT was also confirmed, with no device-related mortality, no additional PE-related mortality past seven days, and no difference in symptomatic PE-recurrence.

  • The 90-day results of the STORM-PE RCT were presented at the Society of Interventional Radiology (SIR) annual scientific meeting on April 11-15, 2026 in Toronto, Canada.

The players

Robert Lookstein

Co-global principal investigator of the STORM-PE trial, professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai in New York.

Rachel Rosovsky

Co-global principal investigator of the STORM-PE trial, haematologist at Massachusetts General Hospital in Boston and associate professor of medicine at Harvard Medical School.

James F Benenati

Chief medical officer at Penumbra, the company that manufactures the Lightning Flash device used in the CAVT procedure.

Penumbra

A medical device company that manufactures the Lightning Flash device used in the computer-assisted vacuum thrombectomy (CAVT) procedure.

Society of Interventional Radiology (SIR)

The organization that hosted the annual scientific meeting where the STORM-PE trial results were presented.

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What they’re saying

“Together with the initial STORM‑PE results, which demonstrated faster reperfusion and improved right ventricular recovery, this 90 day data highlights significant patient‑cantered benefits of CAVT in intermediate‑high risk PE.”

— Robert Lookstein, Co-global principal investigator of the STORM-PE trial, professor of radiology and surgery at the Icahn School of Medicine at Mount Sinai

“STORM-PE continues to highlight emerging benefits of treatment beyond anticoagulation alone for patients with intermediate‑high risk PE. These functional endpoints are important because they reflect outcomes that matter to patients and directly affect their daily lives.”

— Rachel Rosovsky, Co-global principal investigator of the STORM-PE trial, haematologist at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School

“Historically, there has been limited randomised evidence describing how different treatment strategies for PE influence longer‑term recovery. In STORM‑PE, those treated with CAVT achieved significantly greater gains in objective functional measures, including six‑minute walk distance, compared to anticoagulation alone.”

— James F Benenati, Chief medical officer at Penumbra

What’s next

The STORM-PE trial results will likely be used to inform future clinical guidelines for the treatment of intermediate-high risk pulmonary embolism, potentially leading to greater adoption of endovascular therapies like CAVT in addition to anticoagulation.

The takeaway

The STORM-PE trial provides robust evidence supporting a greater role for computer-assisted vacuum thrombectomy (CAVT) in the treatment of acute intermediate-high risk pulmonary embolism, as it has been shown to improve functional outcomes and recovery for patients compared to anticoagulation alone.