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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
Ohman EM, Roe MT, Steg PG, et al. Lancet. 2017; 389: 1799-1808.
Study Question: What is the risk of bleeding associated with the combination of low dose rivaroxaban and a P2Y12 inhibitor versus aspirin and a P2Y12 inhibitor in acute coronary syndromes (ACS)?
Study Description: This was a double-blind, multicenter, randomized trial of patients who had unstable angina, non-ST segment elevation myocardial infarction, and ST segment elevation myocardial infarctions. Patients were randomized to receive rivaroxaban 2.5 mg twice daily or aspirin 100 mg daily plus a P2Y12 inhibitor (clopidogrel or ticagrelor) which was chosen at physician discretion. The primary endpoint measured was thrombolysis in myocardial infarction (TIMI) clinically significant bleeding not related to coronary artery bypass grafting up to day 390 after randomization.
Results: At randomization, 1519 patients received rivaroxaban and 1518 received aspirin with 1704 patients treated with ticagrelor and 1333 treated with clopidogrel. Treatment discontinuation occurred in 11% of rivaroxaban patients and 13% of aspirin patients. The primary endpoint was noted in 5% of rivaroxaban patients and 5% of aspirin patients (HR 1.09, 95% CI 0.8-1.5; p = 0.5840). A higher rate of bleeding was noted in the rivaroxaban group compared to the aspirin group (2% vs. 1%; p = 0.0420) when utilizing the ISTH. No difference was found when utilizing the GUSTO or BARC definitions.
Conclusion: The use of low dose rivaroxaban in combination with a P2Y12 inhibitor versus aspirin and a P2Y12 inhibitor resulted in similar bleeding risk.
Perspective: Dual antiplatelet therapy (DAPT) has been the mainstay of ACS; however, few trials have assessed aspirin therapy long term. Ischemic endpoints were exploratory in this study, so this will need to be confirmed since rivaroxaban is not currently FDA approved for ACS. Stratification of who would benefit from DAPT versus low dose rivaroxaban is also a question for future consideration.