Intermediate-high risk pulmonary embolism (PE) remains a therapeutic challenge. Anticoagulation is still the standard treatment, albeit with limited efficacy in patients with right ventricular (RV) dysfunction.
STORM-PE is the first randomized trial comparing mechanical thrombectomy (MT) using the Penumbra Lightning Flash system plus anticoagulation (AC) versus anticoagulation monotherapy.
A total of 100 patients with acute PE ≤14 days, RV dysfunction (RV/LV ratio ≥1.0 on CT angiography), and elevated biomarkers were enrolled. Patients were randomized 1:1 to MT+AC or AC alone. The intervention had to be initiated within 12 hours of randomization, and the primary endpoint was the change in RV/LV ratio at 48 hours.
Results showed a significantly greater reduction in RV/LV ratio with MT (29.7% decrease) compared with AC alone (13.1%; p<0.001), representing a 2.3-fold improvement in RV recovery. Moreover, 2.9 times more patients treated with MT achieved normalization of the RV/LV ratio ≤1.0 at 48 hours (p=0.005).
Regarding safety, the incidence of major adverse events at 7 days was low and comparable between groups (p=0.62), with no significant differences in mortality or major bleeding.
Conclusion
Mechanical thrombectomy with Penumbra Lightning Flash combined with anticoagulation resulted in a faster and more significant improvement in RV function compared with anticoagulation monotherapy in intermediate-high risk PE.
Presented by Robert Lookstein at TCT 2025 Late-Breaking Clinical Trials, October 26, San Francisco, USA.
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