STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism (STRATEGY-PE)

Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Thromboembolism; Pulmonary Embolism
• Intervention / Treatment: Drug: Anticoagulants; Device: Mechanical Thrombectomy Devices; Drug: Thrombolytic Agents

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.

• Study Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: he xu Dr, doctor; Phone Number: +86 153 6611 0045; Email: kilogram@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital
      • Contact: Interventional Vascular Department Director, doctor; Phone Number: +86-25-52271000; Email: kilogram@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with intermediate-high risk acute pulmonary embolism admitted to participating tertiary hospitals with Pulmonary Embolism Response Teams (PERT).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anticoagulation Cohort; Patients receiving standard anticoagulation therapy alone without thrombolysis or mechanical thrombectomy.	Drug: Anticoagulants; Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens.; Other Names: Heparin, Enoxaparin, Rivaroxaban, Apixaban, Dabigatran, Edoxaban, Warfarin
Thrombolysis Cohort; Patients receiving systemic thrombolysis or catheter-directed thrombolysis.	Device: Mechanical Thrombectomy Devices; Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.; Other Names: Indigo Aspiration System, FlowTriever, Acostream
Mechanical Thrombectomy Cohort; Patients undergoing mechanical thrombectomy procedures using percutaneous devices.	Drug: Thrombolytic Agents; Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter.; Other Names: tPA, rt-PA, Urokinase, Tenecteplase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality at 30 Days	The percentage of participants who die from any cause within 30 days of enrollment.	30 days
All-Cause Mortality at 90 Days	The percentage of participants who die from any cause within 90 days of enrollment.	90 days
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.	48 hours ± 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Bleeding Events	Incidence of major bleeding defined by ISTH, GUSTO, or BARC criteria (including intracranial hemorrhage).	48 hours, 7 days, 30 days, 90 days
Clinical Deterioration	Composite of hemodynamic instability, need for rescue therapy (escalation to thrombolysis/MT/ECMO), intubation, or PE-related death.	48 hours, 7 days
6-Minute Walk Test (6MWT) Distance	Change in walking distance from baseline (estimated) to follow-up. Minimal Clinically Important Difference (MCID) ≥30 meters.	30 days, 90 days
Post-VTE Functional Status (PVFS) Score	Assessment of functional limitation due to VTE (Scale 0-5).	30 days, 90 days
Quality of Life (PEmb-QoL)	The questionnaire consists of 9 questions containing 40 items, which are organized into 6 domains: Frequency of Complaints (FC): Assesses the frequency of respiratory and general symptoms (e.g., dyspnea, chest pain). Daily Activity Limitations (AL): Measures limitations in performing activities of daily living (ADL). Work-related Problems (WP): Evaluates difficulties in performing work or school duties. Social Limitations (SL): Assesses restrictions on social activities. Intensity of Complaints (IC): Measures the severity of pain and breathlessness. Emotional Complaints (EC): Captures anxiety, frustration, and fear related to the disease.	90 days
Symptomatic PE Recurrence	Confirmed recurrent PE via CTPA or V/Q scan.	90 days
ICU Length of Stay	Duration of intensive care unit stay during the index hospitalization	From ICU admission to ICU discharge, assessed up to 30 days
Total Hospital Length of Stay	Duration of index hospitalization from emergency department admission to hospital discharge	From hospital admission to hospital discharge, assessed up to 90 days
Total Medical Costs	Direct medical costs incurred during index hospitalization and within 90 days of enrollment, including medications, procedures, and hospitalization	Through 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker Improvement (Troponin, BNP, D-Dimer)	Percentage reduction in cardiac biomarkers and D-Dimer levels.	48 hours, 7 days
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.	Continuous monitoring through 90 days

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Anticoagulation; Acute Pulmonary Embolism; Thrombolysis; Intermediate-High Risk
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Pulmonary Embolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Carbohydrates; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Morpholines; Oxazines; Thiophenes; Coumarins; Benzopyrans; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Cardiovascular Agents; 4-Hydroxycoumarins; Tissue Plasminogen Activator; Hematologic Agents; Rivaroxaban; Dabigatran; Tenecteplase; Enoxaparin; Warfarin; Heparin; Anticoagulants; Fibrinolytic Agents; apixaban; edoxaban; Urokinase-Type Plasminogen Activator
• Other Study ID Numbers: KY20260205-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and data dictionaries will be made available to researchers upon reasonable request after the publication of the primary results.
• IPD Sharing Time Frame: Starting 6 months after publication of the primary results, available for 5 years.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal and whose use of data is for legitimate research purposes. Requests should be directed to the Principal Investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No