American heart journal · 2025
Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Chopard Romain, Hobohm Lukas, Barco Stefano, Bangalore Sripal, Giri Jay, Mahfoud Felix, Moriarty John, Rosenkranz Stephan, Sharp Andrew, Thiele Holger, Toma Catalin, Tapson Victor F, Markovitz Craig D, Rosenberg Stuart P, Konstantinides Stavros, Meneveau Nicolas
Аннотация
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.
CONCLUSION: The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE.
CLINICALTRIALS: gov Identifier: NCT06588634.
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.
CONCLUSION: The PERSEVERE study will assess the potential superiority of LBMT over SoC for the treatment of High-Risk PE.
CLINICALTRIALS: gov Identifier: NCT06588634.