Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,300
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).