medwireNews: The addition of rivaroxaban to aspirin results in a similar relative reduction in the risk for cardiovascular events among patients with stable atherosclerosis and a history of atherosclerotic disease regardless of whether or not they have diabetes, suggests a subgroup analysis of the COMPASS trial.
This trial previously demonstrated that dual antithrombotic treatment with rivaroxaban 2.5 mg twice daily plus aspirin significantly reduced the risk for ischemic events relative to placebo plus aspirin among patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD), explain Deepak Bhatt (Harvard Medical School, Boston, Massachusetts, USA) and colleagues.
The current prespecified subgroup analysis shows that among the 6922 participants with diabetes, treatment with rivaroxaban plus aspirin versus aspirin alone was associated with a significant 26% reduction in the risk for the primary composite efficacy endpoint of cardiovascular death, myocardial infarction, or stroke at the 3-year follow-up.
And for the 11,356 patients without diabetes, combination therapy was associated with a “consistent and similar” 23% risk reduction, report Bhatt and team in Circulation.
However, they say that “the absolute risk reductions appeared larger in patients with diabetes,” given the higher baseline risk in this group.
Absolute rates of the composite outcome were 8.4% with combination therapy compared with 10.7% with aspirin alone for the diabetes group, and 5.8% versus 7.2% for those without diabetes. The numbers needed to treat with combination therapy versus aspirin to avoid one primary outcome event over 3 years were 44 versus 73 for people with diabetes and 54 versus 167 for those without.
In accordance with the main trial results, dual antithrombotic treatment was associated with a significant increase in major bleeding risk. Three-year rates were 4.5% and 3.4% for the combination and aspirin monotherapy groups, respectively, for people with diabetes, and a corresponding 4.4% and 3.2% for those without, representing a significant 69–70% increased risk with dual therapy.
The researchers then combined major bleeding with the primary composite efficacy endpoint, finding no significant difference in risk between the combination versus aspirin alone groups for people both with and without diabetes.
Together, these findings suggest that “greater absolute efficacy occurs without any incremental increase in major bleeding complications in those with versus without diabetes,” pointing to “a larger absolute net clinical benefit in those with diabetes,” say Bhatt and colleagues.
And they conclude: “In patients at acceptable bleeding risk, addition of low-dose rivaroxaban to aspirin should be considered in the secondary prevention regimen of patients with atherosclerosis and diabetes.”
The study findings were also presented at the ACC.20/World Congress of Cardiology Virtual Conference.
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