Aortic & peripheral vascular disease

Effect of low-dose rivaroxaban plus aspirin on 18F-FDG PET/CT-detectable carotid plaque inflammation: a randomized trial

Eur Heart J Cardiovasc ImagingPublished

Primary result · Per cent change in the most diseased segment (MDS) TBR of the index carotid arteryAdjusted between-group difference −1.50 percentage points 95% CI −6.20 to 3.21
  • single-centre, randomized, open-label, proof-of-concept trial with blinded endpoint assessment

Authors' conclusion

In patients with carotid atherosclerosis, adding low-dose rivaroxaban to aspirin did not produce a detectable incremental reduction in 18F-FDG PET/CT-assessed carotid plaque inflammation compared with aspirin alone over 12 months.

Study context

Population
Adults with asymptomatic carotid stenosis (20–80%) and elevated carotid FDG uptake (TBR ≥ 1.6)randomized, 81 (88%) completed paired imaging
Participants
92 adults
Comparison
aspirin plus rivaroxaban or aspirin alone
Primary endpoint
Per cent change in the most diseased segment (MDS) TBR of the index carotid artery
Follow-up
12 months

Primary result

As reported in the abstract

Per cent change in the most diseased segment (MDS) TBR of the index carotid artery

Adjusted between-group difference

−1.50 percentage points

95% CI −6.20 to 3.21

P = 0.529

By group

combination therapy

−7.25%

mean per cent change · 95% CI −11.03–-3.48

aspirin alone

−7.36%

mean per cent change · 95% CI −11.06–-3.67

combination therapy vs aspirin alone
adjusted between-group difference −1.50 percentage points (95% CI −6.20 to 3.21); P = 0.529

Secondary outcomes

Secondary imaging endpoints

Secondary imaging endpoints were concordant

Laboratory parameters

Laboratory parameters were similar, except for a nominal high-sensitivity C-reactive protein (hsCRP) difference
  • without multiplicity adjustment

Safety

Minor bleeding

Minor bleeding

Minor bleeding occurred in four (8.7%) patients with combination therapy and one (2.2%) patient with aspirin alone; no major bleeding or deaths occurred

Original publication

Effect of low-dose rivaroxaban plus aspirin on 18F-FDG PET/CT-detectable carotid plaque inflammation: a randomized trial. Eur Heart J Cardiovasc Imaging. Published 13 July 2026. doi:10.1093/ehjci/jeag176

Summarised from the published abstract; every number is checked against it