Acute pulmonary embolism (PE) is the third most common cardiovascular cause of death. In patients with intermediate-high risk acute PE, percutaneous mechanical thrombectomy (PMT) using large-bore catheters achieves rapid hemodynamic improvement while avoiding the bleeding risk of systemic thrombolysis, and low-dose catheter-directed thrombolysis (CDT) can dissolve residual thrombus with a lower systemic bleeding risk. This prospective, multicenter, non-randomized cohort study aims to compare the safety and efficacy of PMT alone versus PMT combined with low-dose CDT (PMT+LDCDT) in patients with acute intermediate-high risk PE. Approximately 150 patients will be enrolled and allocated to either PMT alone or PMT+LDCDT based on operator assessment. The primary safety endpoint is the composite incidence of major adverse events (MAE) within 48 hours, and the primary efficacy endpoint is the change in the right ventricular/left ventricular (RV/LV) diameter ratio from baseline to 48 hours assessed by a CTPA core laboratory.
Age 18-80 years.
Acute pulmonary embolism confirmed by CTPA, with symptom onset to diagnosis ≤14 days.
Imaging evidence of right ventricular dysfunction (CTPA RV/LV diameter ratio ≥1.0, or echocardiographic right ventricular dilation/hypokinesia) and elevated cardiac injury biomarkers (troponin I or T above the upper limit of normal).
Presence of a contraindication to systemic thrombolysis, or failure of systemic thrombolysis, or clinical deterioration during anticoagulation.
Cardiac arrest at enrollment; systolic blood pressure <80 mmHg for >15 minutes unresponsive to fluid resuscitation and vasopressors.
Active bleeding; known coagulopathy (INR >2.0 or platelet count <50×10⁹/L); intracranial hemorrhage within 90 days, or intracranial tumor/vascular malformation; major surgery, major trauma, or stroke within 30 days.
Known heparin allergy or a history of heparin-induced thrombocytopenia.
Prior systemic thrombolytic therapy.
Parallel
PMT alone (percutaneous mechanical thrombectomy only)
DevicePercutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system)
PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)
DeviceLow-dose catheter-directed thrombolysis: Alteplase (rt-PA), ≤20 mg (≤10 mg per lung), infused over ≤30 min via pulmonary artery catheter
Composite incidence of major adverse events (MAE) within 48 hours after the procedure
Change in the RV/LV diameter ratio from baseline to 48 hours (ΔRV/LV) measured by CTPA core laboratory
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Qiu Jipeng
Lead sponsor
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Sponsor institution
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