Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 13
- 主要终点
- Composite of severe bleeding or mortality at 30 days
研究概览
简要总结
International guidelines recommend immediate reperfusion with systemic thrombolysis (ST) as first-line treatment in high-risk pulmonary embolism (PE). The therapy improves hemodynamics and overall survival but is also associated with a significant risk of severe bleeding. Catheter-directed intervention (CDI) is recommended as an alternative reperfusion therapy in high-risk PE when ST is contraindicated or has failed, as well as in patients who deteriorate or fail to improve during anticoagulation (AC) treatment. Despite lack of high-quality evidence and randomized studies between CDI and standard care, the use of CDI is spreading rapidly in high-risk PE and in less severe PE not fulfilling current treatment criteria.
详细描述
Several CDI methods are available, including mechanical thrombectomy (MT) and catheter-directed thrombolysis (CDT), but no method is currently recommended over the other. In Sweden, the MT device FlowTriever® (FT) was introduced in 2021 and has since then been the predominant method. Industry sponsored trials have investigated FT in uncontrolled observational trials and primarily in intermediate-risk PE. The investigator-initiated research on FT is limited to relatively small, descriptive, single-arm studies, or trials focusing on intermediate-risk PE.
There are several ongoing trials comparing different CDI methods to anticoagulation. However, in clinical practice, patients with acute PE may be subjected to different reperfusion strategies depending on severity and available resources. The PE-NORDIC observational study will compare the outcomes of different patient groups treated with current CDI methods used in the Nordic countries to patients treated with ST.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (≥18 years), including pregnant women, with verified (CTPA, angiography or scintigraphy) acute pulmonary embolism who are planned for, or have received, treatment with catheter directed intervention or systemic thrombolysis
- •Informed consent (for patients who do not survive before informed consent can be obtained, a waiver of consent applies)
排除标准
- •Ongoing enrolment in interventional catheter directed intervention trial
- •Surgical embolectomy as primary reperfusion treatment
研究组 & 干预措施
Catheter-directed intervention
Catheter-directed intervention, any device
干预措施: Catheter directed intervention, any device (Procedure)
Systemic thrombolysis
Intravenous thrombolysis with tissue-type plasminogen activator (tPA)
干预措施: Alteplase (Drug)
结局指标
主要结局
Composite of severe bleeding or mortality at 30 days
时间窗: From treatment to day 30 after treatment
A composite of severe bleeding according to GUSTO (defined as intracranial bleeding or bleeding with substantial hemodynamic com-promise requiring treatment) or death within 30 days after treatment
次要结局
- Mortality(30 days)
- Bleeding(30 days)
- Rescue treatment(30 days)
- Recurrent PE(30 days)
- Hospital free days(30 days)
- ICU/HDU free days(30 days)
- Change in RV/LV ratio(72 hours)
- RV dysfunction(1 year)
- Persisting dyspnea(1 year)
- 6-minute walk test(1 year)
- Sit-to-stand 60 test(1 year)
- PEmb-QoL(1 year)
- MRC dyspnoea scale(1 year)
- EQ-5D-5L(1 year)
- PVFS scale(1 year)
- Incidence of CTED/CTEPH(1 year)
- Cardiac biomarkers(1 year)
研究者
Kristina Svennerholm
Principal investigator. MD. PhD.
Sahlgrenska University Hospital