This study aims to compare the effectiveness and safety of three treatment strategies (Anticoagulation, Thrombolysis, and Mechanical Thrombectomy) for patients with intermediate-high risk acute pulmonary embolism (PE) in a real-world setting. Approximately 1,300 patients will be enrolled across multiple centers in China. Patients will be followed for 90 days to assess mortality, heart function recovery, bleeding risks, and quality of life. The results will help guide personalized treatment decisions and healthcare policy.
Age unlimited (reflecting real-world population).
Symptom duration of acute PE ≤ 14 days.
Confirmed acute PE by CTPA involving main or lobar pulmonary arteries.
RV/LV ratio ≥ 0.9 (by CT or Echocardiography).
Already received thrombolysis or mechanical thrombectomy for the current episode prior to enrollment.
Unable to obtain baseline or follow-up CTPA imaging.
(Note: Unlike strict RCTs, patients with cancer, renal insufficiency, or advanced age are NOT excluded to ensure real-world representativeness).
Patients diagnosed with intermediate-high risk acute pulmonary embolism admitted to participating tertiary hospitals with Pulmonary Embolism Response Teams (PERT).
Cohort
Prospective
Anticoagulants
DrugLow Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens.
Thrombolytic Agents
DrugUrokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter.
Mechanical Thrombectomy Devices
DeviceAny FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.
All-Cause Mortality at 30 Days
The percentage of participants who die from any cause within 30 days of enrollment.
All-Cause Mortality at 90 Days
The percentage of participants who die from any cause within 90 days of enrollment.
Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours
The proportion of participants with a reduction in RV/LV ratio ≥15% from baseline measured by CTPA or Echocardiography.
Major Bleeding Events
Incidence of major bleeding defined by ISTH, GUSTO, or BARC criteria (including intracranial hemorrhage).
Clinical Deterioration
Composite of hemodynamic instability, need for rescue therapy (escalation to thrombolysis/MT/ECMO), intubation, or PE-related death.
6-Minute Walk Test (6MWT) Distance
Change in walking distance from baseline (estimated) to follow-up. Minimal Clinically Important Difference (MCID) ≥30 meters.
Post-VTE Functional Status (PVFS) Score
Assessment of functional limitation due to VTE (Scale 0-5).
Biomarker Improvement (Troponin, BNP, D-Dimer)
Percentage reduction in cardiac biomarkers and D-Dimer levels.
Daily Step Count
Average daily step count measured by smart band (e.g., Xiaomi/Huawei/Apple Watch) during the 90-day follow-up period. Assessed as a continuous variable (steps/day) and correlated with 6-Minute Walk Test distance and Post-VTE Functional Status score.
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