The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.
Informed Consent as documented by signature
Age ≥18 years
Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
Clinical instability (systolic blood pressure <100 mm Hg or arterial Oxygen saturation <92% at ambient air) at the time of presentation
Parallel
Rivaroxaban
DrugAnticoagulation
Placebo
DrugStudy drug without active agent
Recurrent venous thromboembolism
Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis)
Clinically significant bleeding
Proportion of the composite of major and clinically relevant non-major bleeding
All-cause mortality
Proportion of deaths (all causes of death will be considered)
Health-related quality of life
Pulmonary embolism related quality of life as assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Functional status
Functional status as assessed by the post-venous thromboembolism functional status scale
Initial length of stay (LOS)
Defined as the time/date of discharge minus time/date of admission at the emergency department
Subsequent overall hospitalizations
Number of overall hospitalizations
Click on the lead sponsor to view all of their trials.
Drahomir Aujesky
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
University of Bern
Collaborator
Schweizerischer Nationalfonds
Collaborator
Leiden University Medical Center
Collaborator
The Ottawa Hospital
Collaborator
Bayer
Collaborator
