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Randomized Controlled Trial
. 2025 Nov:255:109420.
doi: 10.1016/j.thromres.2025.109420. Epub 2025 Aug 7.

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

W J E Stenger  1 , C A den Uil  2 , W J R Rietdijk  3 , I Al Amri  4 , J M Montero-Cabezas  5 , C V Elzo Kraemer  6 , T E van Mens  7 , C L Meuwese  8 , N M D A van Mieghem  9 , M N Lauw  10 , L M van den Toorn  11 , S Levolger  12 , K M van de Luijtgaarden  13 , R A Sprenger  14 , J M van Dongen  15 , F Imani  16 , M Meuwissen  17 , K M Kant  18 , R A H M Aarts  19 , K Winckers  20 , R J B Brans  21 , G J A J M Kuiper  22 , R Schnabel  23 , Y M Ende-Verhaar  24 , T A J Urlings  25 , T A Ruys  26 , S Slot  27 , H J Scheffer  28 , S O J H Adriaansens  29 , M F Boomsma  30 , I M Nijholt  31 , S Walen  32 , J Leentjens  33 , S Jenniskens  34 , R J van Geuns  35 , A Griffioen  36 , M Nijkeuter  37 , D Ruigrok  38 , J A Vos  39 , D A Kies  40 , P R Tuinman  41 , R J Lely  42 , B B van der Meijs  43 , M M C Hovens  44 , S V Konstantinides  45 , M S Mol  46 , A O Kraaijeveld  47 , F A Klok  48 ; Contributing authors
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Free article
Randomized Controlled Trial

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

W J E Stenger et al. Thromb Res. 2025 Nov.
Free article

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.

Keywords: Pulmonary embolism; Randomized controlled trial; Shock; Thrombectomy; Thrombolytic therapy.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: CAU reports financial support was provided by Netherlands Health Care Institute & the Netherlands Organization for Health Research and Development. CAU reports financial support was provided by Dutch Heart Foundation. CAU reports financial support was provided by Inari Medical Inc. CAU reports financial support was provided by Penumbra Inc. IAM received speaker fees from Penumbra Inc. and Medtronic, outside this work and paid to the institution. JMMC received research funds from Shockwave Medical and EIT Health and consultant/speaker fees from Shockwave Medical, Abiomed, Boston Scientific, Penumbra Inc. and Angiodynamics, outside this work and paid to the institution. CVEK received consultant payment from Baxter, outside this work and paid to the institution. CLM reports having received research funds from the Dutch Heart Foundation, Foundation SGS and speaker fees from AOP, outside this work and paid to the institution. NVM received research grants from Abbott Vascular, Medtronic, Boston Scientific, Daiichi Sankyo, Teleflex and advisory fees from Anteris, JenaValve, Siemens, Polares, Pie Medical, Materialise, PulseCath BV, Abiomed, Abbott Vascular, Medtronic, Boston Scientific, Daiichi Sankyo, Teleflex, outside this work and paid to the institution. MNL received research funding from Leo Pharma, outside this work and paid to her institution. SL received funding by qure.ai, outside this work and paid to the institution. HJS is paid consultant for AngioDynamiscs, outside this work and paid to the institution. SVK received institutional grants and personal lecture/consultant fees from Bayer AG, Daiichi-Sankyo, Inari Medical, Penumbra Inc. and Boston Scientific. AOK received research funding from Xenios AG and consultancy payments from Philips, all outside this work and paid to his institution. FAK received research funding from Bayer, BMS, BSCI, AstraZeneca, MSD, Leo Pharma, Actelion, VarmX, The Netherlands Organisation for Health Research and Development, The Dutch Heart Foundation, and the Horizon Europe Program, all outside this work and paid to his institution. ARB is in the advisory board BMS, AstraZeneca, all outside this work and paid to his institution. All other authors have nothing to disclose. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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