Effect of Low-Dose Rivaroxaban Plus Aspirin on 18F-FDG PET/CT-Detectable Carotid Plaque Inflammation: A Randomised Trial
In brief
Low-dose rivaroxaban adds no extra plaque inflammation reduction to aspirin
In a trial of 92 patients with asymptomatic carotid stenosis, both aspirin alone and aspirin plus low-dose rivaroxaban reduced FDG-PET measured plaque inflammation by about 7% over 12 months, with no statistically meaningful difference between groups (difference ≈ -1.5%). Minor bleeding was slightly more common with the combination, and no major bleeding occurred, indicating that adding rivaroxaban does not provide additional imaging-detected anti-inflammatory benefit.
- Journal
- European heart journal. Cardiovascular Imaging (Q1)
- Published
- 13 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Tae Oh Kim, Sangwon Han, Jeongryul Ryu, Jung Bok Lee, Chong Hyun Suh, Seong-Bong Wee, et al.
- PMID
- 42439277
- DOI
- 10.1093/ehjci/jeag176
Why clinicians should know about it
- Picked for Radiology, Radiation Oncology, Nuclear Medicine, Medical Physics and Imaging (top studies of the week, 18 October 2026): Rivaroxaban + aspirin RCT with FDG PET/CT plaque inflammation
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.