Reperfusion Treatment in Acute Pulmonary Embolism

Официальное название

Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Catheter directed intervention, any device
  Catheter directed intervention for treatment of pulmonary embolism
• Препарат Alteplase
  Systemic thrombolysis

Первичные конечные точки

• Composite of severe bleeding or mortality at 30 days [Срок оценки: From treatment to day 30 after treatment]

Вторичные конечные точки (12)

• Mortality [Срок оценки: 30 days]
• Mortality [Срок оценки: 30 days]
• Bleeding [Срок оценки: 30 days]
• Rescue treatment [Срок оценки: 30 days]
• Recurrent PE [Срок оценки: 30 days]
• Hospital free days [Срок оценки: 30 days]
• ICU/HDU free days [Срок оценки: 30 days]
• Change in RV/LV ratio [Срок оценки: 72 hours]
• RV dysfunction [Срок оценки: 1 year]
• Persisting dyspnea [Срок оценки: 1 year]
• 6-minute walk test [Срок оценки: 1 year]
• Sit-to-stand 60 test [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Ongoing enrolment in interventional catheter directed intervention trial
• Surgical embolectomy as primary reperfusion treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Швеция · 10 центров

• Sahlgrenska University Hospital — Gothenburg
• Linköping University Hospital — Linköping
• Sunderby Hospital — Luleå
• Skåne University Hospital — Lund
• Örebro University Hospital — Örebro
• Danderyd Hospital — Stockholm
• Karolinska University Hospital Huddinge — Stockholm
• Karolinska University Hospital Solna — Stockholm
• … и ещё 2 центра

Дания · 3 центра

• Aarhus University Hospital — Aarhus
• Rigshospitalet — Copenhagen
• Odense University Hospital — Odense

Публикации

• Einarsson Askeli F, Andersen A, Glise Sandblad K, Martinell L, Pivodic A, Rylander C, Tavoly M, Svennerholm K; PE-NORDIC Investigators. Reperfusion treatment strategies in acute pulmonary embolism: Study protocol for a multicenter prospective observational study in the Nordic countries (PE-NORDIC). Thromb Res. 2026 Apr;260:109635. doi: 10.1016/j.thromres.2026.109635. Epub 2026 Mar 3. PMID 41812431

Идентификаторы

NCT: NCT07003646 · PE-NORDIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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