The STRATIFY II trial investigates the efficacy of three different approaches to reducing thrombus burdon in patients with acute intermediate high-risk pulmonary embolism: percutaneous embolectomy (the AlphaVAC(R), AngioDynamics or the Flow Triever® system, INARI medical), Low intravenous thrombolysis (Alteplase 10 mg) and heparin with the option to perform full-dose thrombolysis. As a co-primary secondary end point the trial assess the incremental efficacy of the embolectomy vs the catheter based low dose thrombolysis approach.
Thus the two main hypothesis being tested are:
1. Thrombus burden reduction after 48-96 h is increased with a catheter based (embolectomy or low-dose alteplase) compared to the a heparin with optional high dose thrombolysis approach (1st co-primary outcome) 2. Thrombus burden reduction after 48-96 h is increased with percutaneous embolectomy compared to low-dose alteplase (2nd co-primary outcome)
Age ≥ 18 years
Intermediate high-risk PE according to ESC criteria
Class II risk assessed by the Pulmonary Embolism Severity Index (1).
Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
Altered mental state (GCS < 14)
No qualifying CT angiography performed (> 24 hour since CT angiography)
Women of childbearing potential, unless negative HCG test is present.
Thrombolysis for PE within 14 days of randomization
Parallel
Ultrasound assisted Thrombolysis
DevicePlease see Arms
Percutaneous Embolectomy
DevicePlease see arms
Heparin
DrugActive comparator
Thrombus burdon reduction (intervention vs. heparin)
Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and low dose thrombolysis) to heparin/LMWH alone group, p\<0.01 (n=140 vs. n=70)
Thrombus burdon reduction (USAT vs. embolektomy)
Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and low dose thrombolysis, p\<0.04 (n=70 vs n=70)
Bleeding complications (major and minor bleeding complication according the TIMI classification)
TIMI classification
Duration of index admission, including hospital based rehabilitation
Duration of index admission
Dyspnea index (Visual analog scale) after 48-96 hours and after 3 months
Duration of index admission
Rate of further interventions for pulmonary embolism during index admission
(embolectomy, full dose thrombolysis, mechanical ventilation, need for vasopressors, cardio pulmonary resusuctation, VA-ECMO etc)
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Jesper Kjaergaard
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Zealand University Hospital
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
