Thrombectomy in high-risk pulmonary embolism - device versus thrombolysis: rationale and design of the TORPEDO-NL investigator-initiated, academically-sponsored, multicenter, open-label randomized controlled trial

Abstract

BACKGROUND: Catheter-directed thrombectomy (CDT) is a promising alternative to full dose thrombolysis in patients with acute high-risk pulmonary embolism (PE), expected to have a more direct effect on pulmonary artery clot burden and a better safety profile. Randomized trials evaluating the safety and efficacy of CDT in high-risk patients are currently unavailable. METHODS AND RESULTS: The TORPEDO-NL study is an investigator-initiated, publicly-funded, multicenter, open-label randomized controlled trial designed to evaluate the superiority of CDT over systemic thrombolysis in patients with high-risk PE. Adults with: 1) confirmed acute PE, 2) a high risk for mortality, and 3) CDT available and technically feasible, will be randomized 2:1 to CDT versus systemic thrombolysis. The primary outcome is the composite incidence of all-cause mortality, treatment failure, major bleeding, and all-cause stroke at day 30. Secondary outcomes include desirability of outcome ranking (DOOR) at day 7, length of hospital stay, patient-reported outcomes including quality of life and symptom burden, functional recovery, and 1-year cost-effectiveness. The trial anticipates recruiting 111 patients and is funded by the The Netherlands Health Care Institute, The Netherlands Organization for Health Research and Development, the Dutch Heart Foundation, and unrestricted grants from Penumbra Inc. and Inari Medical. CLINICALTRIALS: gov number, NCT06833827. CONCLUSIONS: TORPEDO-NL is the first publicly-funded randomized trial to investigate the effect of CDT treatment specifically in high-risk PE patients. The trial is anticipated to play an important role in revising recommendations for high-risk PE treatment in international guidelines.