The combination of rivaroxaban plus aspirin may provide a similar benefit in reducing cardiovascular events in patients with stable atherosclerosis with and without diabetes, according to results of a substudy of the COMPASS trial presented March 28 at ACC.20/WCC during a Featured Clinical Research session and simultaneously published in Circulation.

Deepak L. Bhatt, MD, MPH, FACC, et al., compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg vs. placebo plus aspirin 100 mg on cardiovascular events in patients with and without diabetes and stable coronary or peripheral artery disease in this prespecified analysis.

The overall COMPASS trial included 10,341 patients with diabetes and 17,054 without diabetes. A total of 9,152 patients were randomly assigned to take rivaroxaban plus aspirin, and 9,126 patients took a placebo plus aspirin. The substudy consisted of 6,922 patients with diabetes at baseline and 11,356 without diabetes at baseline.

The primary efficacy endpoint – a composite of cardiovascular death, myocardial infarction (MI) or stroke – occurred in 8.4% of patients with diabetes taking rivaboxaban vs. 10.7% in the placebo group (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.61-0.90; p=0.002). Among patients without diabetes, 5.8% in the rivaroxaban group experienced a primary endpoint event vs. 7.2% in the placebo group (HR, 0.77; 95% CI, 0.64-0.93; p=0.005).

The researchers note a consistent, similar relative risk reduction associated with rivaroxaban plus aspirin for patients both with and without diabetes. Due to higher baseline risk, the absolute risk reduction appeared larger in patients with diabetes vs. without diabetes, but both subgroups derived similar benefits (2.3% vs. 1.4% for the primary endpoint at three years).

The primary safety endpoint was a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria for major bleeding. For patients with diabetes, major bleeding increased from 3.4% to 4.5% at three years (HR, 1.69; 95% CI, 1.33-2.15; p=0.0006) vs. 3.2% to 4.4% for those without diabetes (HR, 1.69; 95% CI, 1.33-2.15; p<0.0001). However, there was no increase in fatal or intracranial bleeding.

The researchers conclude that a low dose of rivaroxaban plus aspirin was associated with a reduction in major cardiovascular events in patients with stable atherosclerosis both with and without diabetes. They note the net clinical benefit for irreversible outcomes appeared numerically grater in patients with diabetes.

Clinical Topics: Acute Coronary Syndromes, Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC Annual Scientific Session, acc20, Aspirin, Myocardial Infarction, Stroke, Hemorrhage, Diabetes Mellitus, Acute Coronary Syndrome, Heart Failure, Metabolic Syndrome

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