Dual-pathway antithrombotic therapy with rivaroxaban and aspirin for the treatment of chronic atherosclerotic vascular disease was found not to require adjustment based on body mass index (BMI) or weight, according to a study published in the Journal of the American College of Cardiology.

In this secondary analysis of the Cardiovascular OutcoMes for People using Anticoagulation StrategieS trial (ClinicalTrials.gov Identifier: NCT01776424), the data of 27,395 patients with chronic coronary artery disease or peripheral artery disease was further examined in relation to BMI and body weight. Trial participants were randomly assigned to receive 2.5 mg rivaroxaban twice-daily plus 100 mg aspirin once-daily or 100 mg aspirin once-daily. The study’s primary efficacy outcome was a composite of cardiovascular death, stroke, or myocardial infarction (MI).

Participants were grouped based on body mass index (normal BMI: 18.5 kg/m2 to <25 kg/m2; n=6459; overweight: BMI from 25 kg/m2 to <30 kg/m2; n=12,047; and obese: BMI ≥30 kg/m2; n=8701) and body weight (≤70 kg: n=7315; 70 to ≤90 kg: n=13,140; >90 kg: n=6921; and ≤120 kg vs >120 kg).

The rates of primary outcomes were reduced across BMI and body weight subgroups in patients receiving dual therapy vs aspirin alone: normal BMI: 3.5% vs 0.5%, respectively (hazard ratio [HR], 0.73; 95% CI, 0.58-0.90);  overweight BMI: 4.3% vs 5.1%, respectively (HR, 0.80; 95% CI, 0.66-0.96); and  BMI indicative of obesity: 4.2% vs 6.14.3% vs 5.1%, respectively (HR, 0.71; 95% CI, 0.57-0.86); Body weight ≤70 kg: 4.1% vs 5.3%, respectively (HR, 0.75; 95% CI, 0.62-0.91); body weight 70 to ≤90 kg: 4.1% vs 5.3%, respectively (HR, 0.76; 95% CI, 0.65-0.89); and body weight >90 kg: 4.2% vs 5.7%, respectively (HR, 0.74; 95% CI, 0.61-0.90).


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Benefits of the dual therapy vs aspirin alone were also consistent across BMI and body weight groups for the secondary composite efficacy outcome of ischemic stroke, MI, acute limb ischemia, or death from coronary heart disease.

Across all BMI categories, the combination of rivaroxaban with aspirin vs aspirin alone was associated with an increased risk for major bleeding.

A limitation of this study include the small number of patients in the >120 kg body weight and the BMI <18.5 kg/m2 subgroups.

 “[A] dose adjustment is not necessary in overweight and obese subjects for the dual-pathway anticoagulant regimen in [patients with chronic atherosclerotic vascular disease],” concluded the study authors.

Disclosure: This clinical trial was supported by Bayer AG. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Guzik TJ, Ramasundarahettige C, Pogosova N, et al. Rivaroxaban plus aspirin in obese and overweight patients with vascular disease in the COMPASS trial. J Am Coll Cardiol. 2021;77(5):511-525. doi:10.1016/j.jacc.2020.11.061