Takeaway
- In patients with chronic atherosclerotic vascular disease, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily vs aspirin 100 mg once daily shows consistent reductions in cardiovascular (CV) death, stroke or myocardial infarction (MI) along with the increased risk of major bleeding, irrespective of body mass index (BMI) or body weight, suggesting no need for dose adjustments in the ranges of weights and BMI.
Why this matters
- Findings warrant further studies to determine if similar uniformity of safety and efficacy applies to patients with low body weight and to extremely obese patients.
Study design
- This secondary analysis of the COMPASS trial determined the effects of dual-pathway inhibition antithrombotic regimen (rivaroxaban plus aspirin) vs aspirin alone across a range of patient BMIs and body weights.
- BMI was categorised as normal (n=6459: 18.5-25 kg/m2), overweight (n=12047: 25-30 kg/m2) and obese (n=8701: ≥30 kg/m2) and body weight into ≤70 kg (n=7315), 70-90 kg (n=13,140) and >90 kg (n=6921).
- In the COMPASS trial, 27,395 patients were randomly assigned to receive rivaroxaban plus aspirin or rivaroxaban alone or aspirin alone.
- Funding: COMPASS trial was funded by Bayer AG.
Key results
- Rivaroxaban plus aspirin vs aspirin alone showed a consistent reduction in the primary composite outcome of CV death, stroke and MI, irrespective of BMI or body weight (HR; 95% credible interval [Crl]):
- BMI:
- normal (0.73; 0.58-0.90);
- overweight (0.80; 0.66-0.96); and
- obese (0.71; 0.57-0.86).
- Body weight:
- ≤70 kg (0.75; 0.62-0.91);
- 70-90 kg (0.76; 0.65-0.89); and
- >90 kg (0.74; 0.61-0.90).
- BMI:
- Effects on bleeding, mortality and net clinical benefit (a composite of CV mortality, stroke, MI, fatal bleeding or symptomatic bleeding into critical organ) were consistent irrespective of BMI or body weight.
Limitations
- Secondary analysis.
This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.
