STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Anticoagulants, Thrombolytic Agents, Mechanical Thrombectomy Devices.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Embolism, Venous Thromboembolism. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Anticoagulants
Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens. - Препарат Thrombolytic Agents
Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter. - Устройство Mechanical Thrombectomy Devices
Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.
Первичные конечные точки
- All-Cause Mortality at 30 Days [Срок оценки: 30 days]
- All-Cause Mortality at 90 Days [Срок оценки: 90 days]
- Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours [Срок оценки: 48 hours ± 6 hours]
Вторичные конечные точки (9)
- Major Bleeding Events [Срок оценки: 48 hours, 7 days, 30 days, 90 days]
- Clinical Deterioration [Срок оценки: 48 hours, 7 days]
- 6-Minute Walk Test (6MWT) Distance [Срок оценки: 30 days, 90 days]
- Post-VTE Functional Status (PVFS) Score [Срок оценки: 30 days, 90 days]
- Quality of Life (PEmb-QoL) [Срок оценки: 90 days]
- Symptomatic PE Recurrence [Срок оценки: 90 days]
- ICU Length of Stay [Срок оценки: From ICU admission to ICU discharge, assessed up to 30 days]
- Total Hospital Length of Stay [Срок оценки: From hospital admission to hospital discharge, assessed up to 90 days]
- Total Medical Costs [Срок оценки: Through 90 days]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Nanjing First Hospital — Нанкин
Идентификаторы
NCT: NCT07603700 · KY20260205-04