Why the study?
Does rivaroxaban reduce cardiovascular death, myocardial infarction, or stroke in patients with acute coronary syndrome?
Does rivaroxaban reduce cardiovascular death, myocardial infarction, or stroke in patients with acute coronary syndrome?
Rivaroxaban 2.5 mg twice daily reduces mortality and ischemic events in ACS patients on DAPT, though with an increased risk of non-fatal major bleeding, suggesting a role in high-risk individuals with low bleeding risk.
May support rivaroxaban 2.5 mg BID in select ACS patients on DAPT; leaves open optimal use pending contemporary trials.
Patients with acute coronary syndrome (ACS) continue to be at risk for recurrent ischemic events, despite an early invasive strategy and the use of dual antiplatelet therapy. The anticoagulant pathway remains activated for a prolonged period after ACS and, consequently, has been a target for treatment. Early studies with warfarin indicated its benefit, but the risk of bleeding and the complexities of warfarin anticoagulation resulted in little use of this strategy. Rivaroxaban, apixaban, and dabigatran are new specific inhibitors of anticoagulant factors (Xa or IIa) currently available for the prevention of thrombosis and/or thromboembolism. Thus far, studies with dabigatran and apixaban in ACS have shown no clinical benefit and bleeding has been increased. The ATLAS ACS 2-TIMI 51 trial observed the impact of rivaroxaban 2.5 mg and 5 mg twice daily in patients with recent ACS receiving current management (both early invasive strategy and dual antiplatelet therapy with aspirin and clopidogrel) over a follow-up period of over 1 year. Rivaroxaban 2.5 mg twice daily reduced cardiovascular death, myocardial infarction, or stroke by 16%, and both cardiovascular and all-cause mortality by approximately 20%. Although major bleeding increased from 0.6% to 2.1% and intracranial hemorrhage from 0.2% to 0.6%, there was no increase in fatal bleeding. The role of rivaroxaban in the management of ACS is discussed in this review. The reduction in mortality is the main finding that could lead to the use of rivaroxaban in the management of ACS in high-risk individuals with a low bleeding risk.
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David Fitchett (2012) studied this question.
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