Is Low-Dose Rivaroxaban Safe for Patients with Acute Coronary Syndromes?
Dual pathway antithrombotic therapy combining low-dose rivaroxaban with a P2Y12 inhibitor yields a similar risk of clinically significant bleeding as aspirin and a P2Y12 inhibitor in patients with acute coronary syndromes, according to the results of a recent study.
The researchers conducted a double-blind, multicenter, randomized trial held at 371 clinical centers in 21 countries. Participants had unstable angina, non-ST segment elevation myocardial infarction, or ST segment elevation myocardial infarction, with positive cardiac biomarkers and either ischemic electrocardiographic changes or an atherosclerotic culprit lesion identified during angiography.
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The participants were randomly assigned to either aspirin (100 mg) once daily (n=1518) or rivaroxaban (2.5 mg) twice daily (n=1519) for a minimum of 180 days. This was combined with either clopidogrel or ticagrelor, depending on investigator preference.
Overall, TIMI non-CABG clinically significant bleeding was similar in both the rivaroxaban and aspirin groups (80 participants of 1519 vs 74 participants of 1518).
“A dual pathway antithrombotic therapy approach combining low-dose rivaroxaban with a P2Y12 inhibitor for the treatment of patients with acute coronary syndromes had similar risk of clinically significant bleeding as aspirin and a P2Y12 inhibitor. A larger, adequately powered trial would be required to definitively assess the efficacy and safety of this approach,” the researchers concluded.
—Michael Potts
Reference:
Ohman EM, Roe MT, Steg PG, et al. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017;389(10081):1799-1808.