Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE)
Key result
SAFE-SSPE trial tests whether clinical surveillance is non-inferior to rivaroxaban for VTE in low-risk SSPE.
Why the study?
The risk-benefit ratio of anticoagulation for isolated subsegmental pulmonary embolism is controversial and evidence from randomized controlled trials is lacking.
Does clinical surveillance without anticoagulation prevent symptomatic recurrent VTE non-inferiorly to rivaroxaban in low-risk patients with isolated subsegmental pulmonary embolism?
Population
Low-risk patients with isolated subsegmental pulmonary embolism
Comparison
Clinical surveillance with placebo vs anticoagulant treatment with rivaroxaban
Design
International multicentre placebo-controlled double-blind parallel-group non-inferiority trial
Follow-up
90 days
Authors
Discussion
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Member takes
Implication
Challenges routine anticoagulation in low-risk isolated SSPE; provides first RCT testing surveillance non-inferiority.
Study Design
Type
RCT
Blinding
double-blind
Randomization
randomised
Multicenter
Yes
Structured PICO
Does clinical surveillance without anticoagulation prevent symptomatic recurrent VTE non-inferiorly to rivaroxaban in low-risk patients with isolated subsegmental pulmonary embolism?
P
Population
Low-risk patients with isolated subsegmental pulmonary embolism (SSPE) who underwent bilateral whole-leg compression ultrasonography to exclude concomitant deep vein thrombosis
I
Intervention
Clinical surveillance with placebo (no anticoagulation)
C
Comparator
Anticoagulant treatment with rivaroxaban
O
Outcome
Symptomatic recurrent VTE at 90 dayshard clinical
This protocol outlines a trial to determine if clinical surveillance without anticoagulation is non-inferior to rivaroxaban for low-risk patients with isolated subsegmental pulmonary embolism.
Cite This Study
Baumgartner et al. (2020) conducted an RCT in isolated subsegmental pulmonary embolism. clinical surveillance with placebo vs. anticoagulant treatment with rivaroxaban was evaluated on symptomatic recurrent VTE. The SAFE-SSPE trial is a randomized, double-blind protocol designed to evaluate whether clinical surveillance is non-inferior to rivaroxaban for preventing recurrent VTE in low-risk isolated SSPE.