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. 2025 Dec 24:107331.
doi: 10.1016/j.ahj.2025.107331. Online ahead of print.

Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: rationale and design of the PERSEVERE randomized controlled trial

Romain Chopard  1 , Lukas Hobohm  2 , Stefano Barco  3 , Sripal Bangalore  4 , Jay Giri  5 , Felix Mahfoud  6 , John Moriarty  7 , Stephan Rosenkranz  8 , Andrew Sharp  9 , Holger Thiele  10 , Catalin Toma  11 , Victor F Tapson  12 , Craig D Markovitz  13 , Stuart P Rosenberg  13 , Stavros Konstantinides  4 , Nicolas Meneveau  14
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Free article

Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: rationale and design of the PERSEVERE randomized controlled trial

Romain Chopard et al. Am Heart J. .
Free article

Abstract

Background: Catheter-directed therapies are increasingly used to treat acute pulmonary embolism (PE). However, randomized data on reperfusion treatments, including large-bore mechanical thrombectomy (LBMT), for patients with High-Risk PE are lacking.

Methods: PERSEVERE (NCT06588634) is a multinational randomized controlled trial comparing the FlowTriever LBMT system vs. standard of care (SoC) in patients with High-Risk PE, with the modified intention-to-treat population planned for 200 patients from 40 sites in Europe and the US. Patients are randomized 1:1 to LBMT or SoC (systemic thrombolysis [ST], surgical embolectomy, extracorporeal membrane oxygenation [ECMO], or anticoagulation alone). Key inclusion criteria are the presence of proximal pulmonary thrombus on computed tomography plus ≥1 of the following: 1) systolic hypotension or need for vasopressors, 2) venous lactate ≥4 mmol/L with clinical signs suggesting obstructive shock, 3) need for mechanical circulatory support, 4) resuscitated cardiac arrest. Exclusion criteria include known chronic thromboembolic pulmonary hypertension and key absolute contraindications to ST. Patients are followed for 3 months. The primary endpoint is a composite of events through hospital discharge or 7 days post randomization, whichever occurs first: 1) all-cause death; 2) cardiac arrest requiring cardiopulmonary resuscitation; 3) bailout to rescue treatment; 4) major bleeding; and 5) ECMO in place on day 7. Secondary endpoints include a broad spectrum of functional and patient-reported outcomes (quality of life, functional status and healthcare resource utilization) at 3 months. The trial is funded by Inari Medical.

Conclusion: The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE.

Keywords: Pulmonary embolism; hemodynamic instability; percutaneous mechanical thrombectomy; randomized controlled trial.

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Conflict of interest statement

Declaration of competing interest S. Barco reports honoraria of low amount from Penumbra, Inari, Concept Medical, and Boston Scientific, and institutional grants from Penumbra and Boston Scientific; Sripal Bangalore reports lecture/consultant fees from Inari, Imperative Care, Argon Medical and Jupiter; Romain Chopard reports lecture/consultant fees from MSD, BMS/Pfizer, Bayer Healthcare, Braun Medical, Edwards Life Science, and Inari Medical, outside the submitted work; Jay Giri reports serving as an advisor to and receiving research funds to the institution from Inari Medical, Boston Scientific, and Endovascular Engineering; Lukas Hobohm reports lecture/consultant fees from Boston Scientific, Inari Medical, MSD and Johnson&Johnson, outside the submitted work; Stavros Konstantinides reports research grants or contracts to his institution from Bayer AG, Boston Scientific, Daiichi Sankyo, Inari Medical, and Penumbra and personal consulting fees from Boston Scientific, Daiichi Sankyo, Inari Medical, and Penumbra; Felix Mahfoud has been supported by Deutsche Forschungsgemeinschaft (SFB TRR219, Project-ID 322900939), and Deutsche Herzstiftung. Saarland University has received scientific support from Ablative Solutions, Medtronic and ReCor Medical. Until May 2024, FM has received speaker honoraria/consulting fees from Ablative Solutions, Astra-Zeneca, Inari, Medtronic, Merck, Novartis, Philips and ReCor Medical; John Moriarty reports consultant fees from Inari Medical, AngioDynamics, Penumbra, Argon Medical, Pavmed, Auxetics, Innova Vascular, Retriever Medical, Truvic, Inquis Medical, and Imperative Care and is president of the PERT Consortium; Nicolas Meneveau reports consultancy agreements with Inari, Abbott, Boston Scientific, Edwards Lifesciences, and Terumo as well as speaker fees from Astra Zeneca, BMS-Pfizer, and Servier; Stephan Rosenkranz reports remunerations for lectures and/or consultancy from Abbott, Acceleron, Actelion, Aerovate, AOP, AstraZeneca, Bayer, BMS, Boehringer-Ingelheim, Edwards, Ferrer, Gossamer, Inari, Janssen, Lilly, Liquidia, MSD, OMT, Pfizer, and United Therapeutics and grants to institution from Actelion, AstraZeneca, Bayer, MSD, and Janssen; Andrew Sharp reports Consultancy/Speaker’s Fees from Philips, Medtronic, Boston Scientific, Penumbra, AngioDynamics and Recor Medical; Holger Thiele reports having no conflicts of interest; Catalin Toma reports a consultancy agreement with Inari and SAB membership for Jupiter Endovascular.

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