CAVT plus anticoagulation reduces 48-hour RV/LV ratio by ~0.27 versus anticoagulation alone.
Why the study?
Patients with intermediate-high risk PE are at risk of early decompensation and mortality, but randomized controlled trial data evaluating the efficacy and safety of mechanical thrombectomy compared with anticoagulation alone were lacking.
Does computer-assisted vacuum thrombectomy with anticoagulation reduce RV/LV ratio at 48 hours in adults with acute intermediate-high risk pulmonary embolism compared to anticoagulation alone?
Population
100 adults with acute intermediate-high risk PE across 22 sites
Comparison
CAVT with anticoagulation vs anticoagulation alone
Design
International randomized controlled trial with blinded core laboratory outcome assessment
Follow-up
7 days
Key result
Computer-assisted vacuum thrombectomy with anticoagulation was superior to anticoagulation alone in reducing RV/LV ratio at 48 hours (difference 0.27; 95% CI 0.12-0.43; P<0.001).
Authors
Discussion
Loading...
Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The field of interventional therapies for acute PE has really expanded rapidly in the last 10 years, but there has not been a randomized controlled trial evaluating any minimally invasive therapy since 2013, so many of us in the interventional space felt that there was a need to establish core data to move the field forward, and that's what STORM-PE was about. We found the addition of the thrombectomy procedure in a statistically significant way dramatically reduced the strain on the right heart as compared to anticoagulation alone.”
“What distinguishes STORM‑PE from prior studies is its deliberate focus on recovery beyond early physiologic improvement. Functional endpoints are critical because they capture outcomes that are most meaningful to patients.”
“The time that the catheter spent in the patient was incredibly short, arguably the shortest recorded time in the modern cardiovascular era. All trial operators were able to deliver the catheters where the thrombus was located and successfully extract the clot. In other words, the technical success was 100%. There were no complications related to either the insertion or removal of the catheter.”
Overview
Mechanical thrombectomy may accelerate early RV/LV normalization in intermediate-high-risk PE; leaves open effects on clinical outcomes.
Key Points
- To evaluate the efficacy and safety of mechanical thrombectomy with anticoagulation versus anticoagulation alone in acute intermediate-high risk pulmonary embolism.
- International multicenter randomized controlled trial with 1:1 randomization
- Eligible adults with acute intermediate-high risk pulmonary embolism and a right ventricular to left ventricular ratio ≥1.0 were enrolled
- Primary endpoint was the change in RV/LV ratio at 48 hours, assessed by a blinded imaging core laboratory.
- CAVT group showed a mean reduction in RV/LV ratio of 0.52 ± 0.37 compared to 0.24 ± 0.40 in the anticoagulation group (P < 0.001)
- Early normalization of vital signs was more frequent in the CAVT group
- The major adverse event rates were comparable between groups (CAVT: 4.3%, anticoagulation: 7.5%, P = 0.681).
Study Design
Type
RCT (n=100)
Blinding
Blinded outcome assessment
Randomization
1:1
Multicenter
Yes
Structured PICO
Does computer-assisted vacuum thrombectomy with anticoagulation reduce RV/LV ratio at 48 hours in adults with acute intermediate-high risk pulmonary embolism compared to anticoagulation alone?
P
Population
100 adults with acute intermediate-high risk pulmonary embolism, normotension, RV/LV ratio ≥1.0, and elevated cardiac biomarkers, assessed at 48 hours.
I
Intervention
Computer-assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System plus anticoagulation
C
Comparator
Anticoagulation alone
O
Outcome
Change in RV/LV ratio at 48 hours, assessed by a blinded independent imaging core laboratorysurrogate
Main Result
Mean Difference: 0.27 (95% CI 0.12–0.43)
Absolute Event Rate: 0.52% vs 0.24%
p-value: p=<0.001
In patients with intermediate-high risk pulmonary embolism, computer-assisted vacuum thrombectomy combined with anticoagulation significantly reduced RV/LV ratio at 48 hours compared to anticoagulation alone, without increasing major adverse events.
Cite This Study
Lookstein et al. (2025) conducted an RCT in Acute intermediate-high risk pulmonary embolism (n=100). Computer-assisted vacuum thrombectomy (CAVT) with anticoagulation vs. Anticoagulation alone was evaluated on Change in RV/LV ratio at 48 hours (MD 0.27, 95% CI 0.12-0.43, p=<0.001). Computer-assisted vacuum thrombectomy with anticoagulation was superior to anticoagulation alone in reducing RV/LV ratio at 48 hours (difference 0.27; 95% CI 0.12-0.43; P<0.001).