For patients with vascular disease, further stratification of the disease by vascular beds affected and presence of heart failure (HF), renal insufficiency, or diabetes can identify those at higher risk. The net clinical benefit remains favorable for most patients treated with rivaroxaban and aspirin compared with aspirin alone, according to results published in the Journal of the American College of Cardiology.
The study included participants with vascular disease from the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. Vascular disease was stratified using 2 methods: Reduction of Atherothrombosis for Continued Health (REACH) atherothrombosis risk score and Classification and Regression Tree (CART) analysis.
The researchers compared the absolute risk differences between rivaroxaban plus aspirin and aspirin alone over 30 months for the composite of cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or vascular amputation; for severe bleeding; and for the net clinical benefit.
Participants were classified as high-risk using the REACH score if ≥2 vascular beds were affected and if they had a history of HF or renal insufficiency. They were classified as high risk using CART analysis if ≥2 vascular beds were affected and they had a history of HF or diabetes.
The results indicated that rivaroxaban plus aspirin reduced the incidence of serious vascular events by 25%, with a rate of 4.48% for rivaroxaban plus aspirin compared with 5.95% for aspirin alone. This was equivalent to preventing 23 events per 1000 patients treated for 30 months.
Rivaroxaban plus aspirin resulted in a nonsignificant increase in severe bleeding (hazard ratio, 1.34; 95% CI, 0.95-1.88).
The researchers found that for participants with ≥1 high-risk feature in the CART analysis, rivaroxaban plus aspirin prevented 33 serious vascular events per 1000 patients compared with 10 events per 1000 patients among lower-risk participants.
“In high-risk patients with vascular disease, further risk stratification can identify higher-risk patients (2 or more vascular beds affected, HF, renal insufficiency, or diabetes) in whom the benefits are substantial….and the net clinical benefit remains favorable for most patients treated with rivaroxaban and aspirin compared with aspirin alone,” the researchers wrote.
Disclosure: This study was supported by Bayer AG. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Anand SS, Eikelboom JW, Dyal L, et al; COMPASS Trial Investigators. Rivaroxaban plus aspirin versus aspirin in relation to vascular risk in the COMPASS trial. J Am Coll Cardiol. 2019;73(25):3271-3280.