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
Abstract
BACKGROUND
Patients with intermediate-high risk pulmonary embolism (PE) have an elevated right-to-left-ventricular (RV/LV) diameter ratio and are at risk of early clinical decompensation and mortality. Reperfusion therapy aims to rapidly relieve acute RV pressure overload and normalize hemodynamics. STORM-PE is the first reported randomized controlled trial (RCT) to test the efficacy and evaluate the safety of mechanical thrombectomy (MT), specifically computer assisted vacuum thrombectomy (CAVT) with anticoagulation (AC) compared to AC alone.
METHODS
STORM-PE is an international RCT with 1:1 randomization to CAVT with AC or AC alone. Eligible adults had acute onset (symptoms ≤14 days), intermediate-high risk PE, and were normotensive, with an RV≤LV ratio ≥1.0 on computed tomography pulmonary angiography and elevated cardiac biomarkers. The primary endpoint analysis tested for a difference between groups for the change in RV/LV ratio at 48 hours, assessed by a blinded independent imaging core laboratory. Secondary endpoints included major adverse events (MAE) within 7 days (a composite of clinical deterioration necessitating rescue therapy, PE-related mortality, symptomatic recurrent PE, and major bleeding), adjudicated by an external clinical events committee. Additional outcomes included change in vital signs and core lab assessed PA obstruction at 48 hours.
RESULTS
A total of 100 patients enrolled across 22 sites were randomized to CAVT (N=47) or AC alone (N=53). Baseline…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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