Adding low-dose rivaroxaban to aspirin did not reduce carotid plaque inflammation compared with aspirin alone over 12 months (difference -1.50 percentage points; P=0.529).
RCT (n=92)
Open-label
1:1
No
Does adding low-dose rivaroxaban to aspirin reduce 18F-FDG PET/CT-detectable carotid plaque inflammation in adults with asymptomatic carotid stenosis?
Adding low-dose rivaroxaban to aspirin does not significantly reduce carotid plaque inflammation assessed by 18F-FDG PET/CT over 12 months in patients with asymptomatic carotid stenosis.
Mean Difference: -1.5 (95% CI -6.2–3.21)
Absolute Event Rate: -7.25% vs -7.36%
p-value: p=0.529
AIMS: Aspirin plus low-dose rivaroxaban reduces cardiovascular events in stable atherosclerosis; its effect on arterial inflammation in humans remains unclear. We tested whether adding low-dose rivaroxaban to aspirin reduces 18F-fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT)-detectable carotid plaque inflammation. METHODS AND RESULTS: In this single-centre, randomised, open-label, proof-of-concept trial with blinded endpoint assessment, adults with asymptomatic carotid stenosis (20%-80%) and elevated carotid FDG uptake (target-to-background ratio TBR ≥ 1.6) were assigned 1:1 to aspirin (100 mg/day) plus rivaroxaban (2.5 mg twice daily) or aspirin alone. The primary endpoint was percent change in the most diseased segment (MDS) TBR of the index carotid artery at 12 months. Secondary endpoints included whole-vessel carotid TBR, aortic TBR, lipid and high-sensitivity C-reactive protein (hsCRP) changes. From September 2021 to December 2023, 92 patients were randomised (mean age 69.4 years; 88% men), and 81 (88%) completed paired imaging. Mean percent changes in MDS TBR were -7.25% (95% confidence interval CI, -11.03 to -3.48) with combination therapy and -7.36% (95% CI, -11.06 to -3.67) with aspirin alone (adjusted between-group difference, -1.50 percentage points, 95% CI, -6.20 to 3.21; P = 0.529). Secondary imaging endpoints were concordant. Laboratory parameters were similar, except for a nominal hsCRP difference without multiplicity adjustment. Minor bleeding occurred in four (8.7%) and one (2.2%) patients, respectively; no major bleeding or deaths occurred. CONCLUSIONS: 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.
Kim et al. (Thu,) conducted a rct in Asymptomatic carotid stenosis (n=92). Rivaroxaban plus aspirin vs. Aspirin alone was evaluated on percent change in the most diseased segment (MDS) TBR of the index carotid artery at 12 months (MD -1.50, 95% CI -6.20 to 3.21, p=0.529). Adding low-dose rivaroxaban to aspirin did not reduce carotid plaque inflammation compared with aspirin alone over 12 months (difference -1.50 percentage points; P=0.529).