A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study

BACKGROUND: Therapeutic anticoagulation (AC) is standard care for pulmonary embolism (PE). Endovascular therapy with mechanical thrombectomy (MT) is commonly performed for PE and well-studied in single-arm trials. The efficacy benefit of MT over AC alone in a randomized fashion remains unstudied. METHODS AND RESULTS: STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team Consortium. Up to 100 patients with confirmed acute intermediate-high-risk PE demonstrated by right ventricular (RV) dysfunction with a right-to-left ventricular (RV/LV) ratio ≥1.0 and elevated cardiac biomarkers will be randomized 1:1 to receive AC alone or AC plus computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra Inc.). The primary outcome is a mean change in RV/LV ratio at 48 hours, assessed by computed tomographic pulmonary angiography (CTPA) and adjudicated by a blinded, independent imaging Core Lab. Additional endpoints are composite major adverse events, functional outcomes (6-minute walk test, New York Heart Association classification, post-venous thromboembolism functional status scale, modified Medical Research Council Dyspnea Scale, Borg Scale), quality of life (Pulmonary Embolism Quality of Life Questionnaire and EQ-5D-5L), mortality, and symptomatic PE recurrence through 90 days. A Clinical Events Committee will adjudicate adverse events for causality and attribution and an independent Data Safety Monitoring Board will oversee the study. STORM-PE is funded by Penumbra Inc. CONCLUSIONS: The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT for patients with acute intermediate-high-risk PE. TRIAL REGISTRATION: STORM-PE, NCT05684796, is registered at https://clinicaltrials.gov/study/NCT05684796.