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STORM-PE RCT—Thrombectomy for Intermediate-High Risk PE

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Written by Millie Cossé

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This RCT of 100 patients with intermediate-high risk PE showed that mechanical thrombectomy plus anticoagulation was superior to anticoagulation alone in reducing RV/LV ratio and earlier normalization of vitals.

There’s a STORM brewin’
The authors of the STORM-PE trial randomized 100 hemodynamically stable patients with acute PE and elevated RV/LV diameter with elevated cardiac biomarkers to either anticoagulation (AC) alone or anticoagulation with computer-assisted vacuum thrombectomy (CAVT).

The primary outcome of this study was change in RV/LV ratio assessed by CTA at 48 hours post-procedure. The CAVT+AC group had greater reduction in RV/LV ratio (0.52±0.37) than the AC group (0.24±0.40), a difference of 0.27 (95%CI 0.12 to 0.43, P<0.001).

While increased RV/LV ratio correlates with an increased risk of mortality, it may not be enough to justify the increased cost and expertise needed to treat these otherwise hemodynamically stable patients. The authors promise a future publication focused on functional outcomes (e.g. 6-minute walk test, post VTE functional status scale, etc.), which I think will be very important in weighing risks and benefits of this procedure. 

How will this change my practice?
When I have a hemodynamically stable patient with an acute PE in my critical access ED, I need more than a surrogate endpoint to recommend transfer for a procedure. I look forward to the next paper coming out, and in the meantime, I will continue to coordinate care closely with regional referral centers. 

Source
STORM-PE Trial Investigators. 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. 2025 Nov 3. doi: 10.1161/CIRCULATIONAHA.125.077232. Epub ahead of print. PMID: 41183181.

View Critical Appraisal

Critical Appraisal

Title: 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.
Background: Patients with intermediate-high risk pulmonary embolism are at risk of early clinical decompensation and mortality due to elevated RV/LV diameter ratio. Reperfusion therapy aims to relieve acute RV pressure overload.
Study Question: Does mechanical thrombectomy with anticoagulation improve outcomes compared to anticoagulation alone in intermediate-high risk PE?
Study Design: Randomized controlled trial with 1:1 randomization.
Population: 100 adults with acute intermediate-high risk PE, normotensive, RV/LV ratio ≥1.0, and elevated cardiac biomarkers.
Intervention: Mechanical thrombectomy with anticoagulation.
Comparison: Anticoagulation alone.
Primary Outcome: Change in RV/LV ratio at 48 hours.
Secondary Outcomes: Major adverse events within 7 days, change in vital signs, and PA obstruction at 48 hours.
Key Statistics: Mean reduction in RV/LV ratio was 0.52±0.37 for CAVT vs 0.24±0.40 for AC; difference of 0.27 (95% CI, 0.12, 0.43; P<0.001).
Results: CAVT significantly reduced RV/LV ratio more than AC alone, with no significant difference in MAE rates between groups.
Risk of Bias – RoB 2:
  • Randomization Process: Randomization was appropriately conducted with allocation concealment.
  • Deviations from Intended Interventions: Interventions were delivered as intended with no significant deviations.
  • Missing Outcome Data: Outcome data were complete with minimal loss to follow-up.
  • Measurement of the Outcome: Outcomes were measured using standardized and validated methods.
  • Selection of the Reported Result: All prespecified outcomes were reported, reducing the risk of selective reporting.
Take Home: Mechanical thrombectomy with anticoagulation is more effective than anticoagulation alone in reducing RV/LV ratio in intermediate-high risk PE, without increasing adverse events.
This critical appraisal is generated using a structured framework applied to the full text of the original article and is presented separately from the physician’s commentary.

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