Pulmonary vascular disease & thromboembolismRandomised controlled trial
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
- Randomised controlled trial
- international
- multicentre (22 sites)
- 1:1 randomisation
- blinded independent imaging core laboratory
Authors' conclusion
CAVT was superior to anticoagulation alone in reducing RV/LV ratio within 48 hours in patients with intermediate-high risk PE, accompanied by earlier normalization of vital signs and major adverse event rates comparable to those for anticoagulation.
Study context
- Population
- Normotensive adults with acute-onset (symptoms ≤14 days) intermediate-high risk pulmonary embolism (PE), right ventricular (RV)/left ventricular (LV) ratio ≥1.0 on CT pulmonary angiography and elevated cardiac biomarkers
- Participants
- 100 adults · 22 sites
- Comparison
- Computer-assisted vacuum thrombectomy (CAVT) with anticoagulation vs anticoagulation alone
- CAVTn = 47
- Anticoagulationn = 53reference
- Primary endpoint
- Change in RV/LV ratio
- Follow-up
- 48 hours
Primary result
Reduction in RV/LV ratio
Difference
0.27
95% CI 0.12–0.43
P < 0.001
By group
CAVT
0.52
mean reduction · SD 0.37
Anticoagulation
0.24
mean reduction · SD 0.40
As reported in the abstract
Secondary outcomes
| Outcome | CAVT | Anticoagulation |
|---|---|---|
| PE-related deaths | 2 events | Not reported in the abstract |
Refined modified and modified Miller scores · 48 hours
- Greater changes with CAVT than anticoagulation alone
- P < 0.001
Normalization of vital signs · within 48 hours
- More frequent after CAVT
Safety
Major adverse events (clinical deterioration needing rescue therapy, PE-related mortality, symptomatic recurrent PE, major bleeding) · within 7 days · not different
P = 0.681
Original publication
Summarised from the published abstract; every number is checked against it