The PERSEVERE study is an ongoing randomized controlled trial of 200 patients aiming to establish the superiority of large-bore mechanical thrombectomy over standard of care for high-risk PE.
RCT (n=200)
1:1
Yes
Does large-bore mechanical thrombectomy improve clinical outcomes compared to standard of care in patients with high-risk pulmonary embolism?
The PERSEVERE study is designed as the first randomized controlled trial to compare large-bore mechanical thrombectomy versus standard of care in patients with high-risk pulmonary embolism.
Abstract Background The frontline therapy for high-risk pulmonary embolism (PE) is systemic thrombolysis (ST). Yet, only one-quarter of high-risk patients receive ST, and in-hospital mortality with ST is 25%. Results from observational studies of large-bore mechanical thrombectomy (LBMT) for high-risk PE are encouraging but randomized data are needed to confirm that LBMT improves outcomes. Purpose To present the design of PERSEVERE, a randomized controlled trial (RCT) evaluating LBMT versus standard of care (SOC) for high-risk PE (Figure). Methods The modified intention-to-treat population in PERSEVERE is planned for 200 patients with high-risk PE. Patients will be enrolled at up to 40 sites in Europe and the United States. All patients receive anticoagulation therapy (AC) and are randomized 1:1 to LBMT or SOC, defined as ST, surgical embolectomy, extracorporeal membrane oxygenation (ECMO) alone, or AC alone. In both arms, ECMO may be used as part of a combinatory primary treatment strategy. Key inclusion criteria are proximal filling defect and one or more of the following: 1) systolic blood pressure (SBP) 90 mmHg for 15 mins, or vasopressor support needed to maintain SBP 90 mmHg, 2) venous lactate ≥4 mmol/L and clinical signs suggesting obstructive shock or hypoperfusion, 3) ECMO before randomization, 4) resuscitation from cardiac arrest suspected to be related to the PE with Glasgow Coma Scale score ≥13 or, if intubated, ≥8T. Key exclusion criteria are chronic thromboembolic pulmonary hypertension or imaging signs of chronic PE, cranial or spinal surgery or stroke in the past 14 days, intracranial tumor, or life-threatening active bleeding into a critical area. Patients are followed for 3 months post randomization. The primary endpoint is a composite of events occurring through the earlier of initial hospital discharge or 7 days post randomization: 1) all-cause mortality, 2) cardiac arrest with loss of consciousness requiring cardiopulmonary resuscitation, 3) bailout to an alternate treatment, 4) major bleeding, and 5) ECMO in place on postrandomization day 7. Secondary endpoints include the individual primary endpoint components, with mortality and bleeding also assessed at the 3-month visit; change in RV/LV ratio at the 72-hour visit; all-cause and PE-related readmissions at 30 and 90 days; days alive outside the hospital at 90 days; and PE-related mortality, PE-related and general health-related quality of life, and Post-PE Impairment at the 3-month visit. As of February 17th, 2025, 1 subject has been enrolled. Conclusions The PERSEVERE study aims to establish the superiority of catheter-based thrombectomy over standard of care for the treatment of high-risk PE and will inform treatment guidelines as the first RCT to compare LBMT versus SOC for patients with high-risk PE.
Meneveau et al. (Sat,) conducted a rct in High-risk pulmonary embolism (n=200). Large-bore mechanical thrombectomy vs. Standard of care (systemic thrombolysis, surgical embolectomy, ECMO alone, or anticoagulation alone) was evaluated on Composite of all-cause mortality, cardiac arrest requiring CPR, bailout to alternate treatment, major bleeding, and ECMO in place on postrandomization day 7. The PERSEVERE study is an ongoing randomized controlled trial of 200 patients aiming to establish the superiority of large-bore mechanical thrombectomy over standard of care for high-risk PE.