STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anticoagulants, Thrombolytic Agents, Mechanical Thrombectomy Devices.
- Who it may be relevant to
- Registry conditions: Pulmonary Embolism, Venous Thromboembolism. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study
Overview
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.
Detailed description
Background: Acute pulmonary embolism (PE) is a severe manifestation of venous thromboembolism (VTE). Intermediate-high risk PE accounts for 20-30% of all PE cases with significant mortality driven by right ventricular (RV) dysfunction. Current guidelines recommend anticoagulation for all, with thrombolysis or mechanical thrombectomy as rescue or alternative therapies. However, there is significant heterogeneity in real-world treatment selection and a lack of head-to-head comparative evidence among the three strategies in complex real-world populations.
Objective: To compare the 30-day and 90-day all-cause mortality and 48-hour RV/LV ratio improvement rate among three treatment strategies (Anticoagulation, Thrombolysis, Mechanical Thrombectomy) in patients with intermediate-high risk acute PE.
Design: This is a prospective, multicenter, non-randomized, pragmatic cohort study. Treatment allocation is based on routine clinical decision-making (natural allocation) without investigator intervention. Advanced statistical methods (Propensity Score Matching/Weighting, Instrumental Variable analysis) will be used to control for confounding factors.
Participants: 1,300 patients with confirmed acute intermediate-high risk PE (RV/LV ratio ≥0.9 and elevated cardiac biomarkers, hemodynamically stable). There are no age limits to reflect real-world diversity.
Interventions/Exposures:
1. Anticoagulation (AC): Standard anticoagulant therapy (LMWH, DOAC, UFH, or Warfarin). 2. Thrombolysis (TL): Systemic thrombolysis or Catheter-Directed Thrombolysis (CDT) using agents like Urokinase, Alteplase, etc. 3. Mechanical Thrombectomy (MT): Mechanical removal of thrombus using FDA/NMPA approved devices (e.g., Indigo, FlowTriever, Acoscream), with or without adjunctive anticoagulation/thrombolysis.
Outcomes:
* Primary: 30-day and 90-day all-cause mortality; 48-hour RV/LV ratio improvement rate (≥15% reduction). * Secondary: Clinical deterioration, major bleeding (ISTH/GUSTO/BARC), functional status (6MWT, NYHA, PVFS), quality of life (PEmb-QoL, EQ-5D-5L), PE recurrence, and healthcare resource utilization.
Follow-up: Patients will be followed at 48 hours, 7 days, 30 days, and 90 days.
Interventions
- Drug Anticoagulants
Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens. - Drug Thrombolytic Agents
Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter. - Device Mechanical Thrombectomy Devices
Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.
Primary outcome measures
- All-Cause Mortality at 30 Days [Time frame: 30 days]
- All-Cause Mortality at 90 Days [Time frame: 90 days]
- Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours [Time frame: 48 hours ± 6 hours]
Secondary outcome measures (9)
- Major Bleeding Events [Time frame: 48 hours, 7 days, 30 days, 90 days]
- Clinical Deterioration [Time frame: 48 hours, 7 days]
- 6-Minute Walk Test (6MWT) Distance [Time frame: 30 days, 90 days]
- Post-VTE Functional Status (PVFS) Score [Time frame: 30 days, 90 days]
- Quality of Life (PEmb-QoL) [Time frame: 90 days]
- Symptomatic PE Recurrence [Time frame: 90 days]
- ICU Length of Stay [Time frame: From ICU admission to ICU discharge, assessed up to 30 days]
- Total Hospital Length of Stay [Time frame: From hospital admission to hospital discharge, assessed up to 90 days]
- Total Medical Costs [Time frame: Through 90 days]
Eligibility criteria
Inclusion criteria
- Age unlimited (reflecting real-world population).
- Symptom duration of acute PE ≤ 14 days.
- Confirmed acute PE by CTPA involving main or lobar pulmonary arteries.
- Defined as Intermediate-High Risk PE meeting all of the following:
- RV/LV ratio ≥ 0.9 (by CT or Echocardiography).
- Elevated cardiac biomarkers (Troponin > 99th percentile or BNP > 100 pg/mL).
- Hemodynamically stable (SBP ≥ 90 mmHg, no vasopressors required).
- Able to provide informed consent and complete follow-up.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanjing First Hospital — Nanjing
Identifiers
NCT: NCT07603700 · KY20260205-04