Rivaroxaban improves CV outcomes after ACS
Adding rivaroxaban to standard treatment with aspirin and a thienopyridine can improve cardiovascular outcomes for patients with acute coronary syndrome (ACS), according to research published online in the New England Journal of Medicine (13 November 2011).
However, Paul Wright, specialist cardiac pharmacist at Barts and The London NHS Trust, told Clinical Pharmacist that, because the study protocol did not include the more potent antiplatelet medicines that are used commonly for these patients, the results will be difficult to translate into practice.
Researchers randomised 15,526 patients who had been admitted to hospital with ACS to receive rivaroxaban (either 2.5mg or 5mg twice a day) or placebo, in addition to standard care with aspirin and a thienopyridine (clopidogrel or ticlodipine).
The primary endpoint — a composite of myocardial infarction, stroke and death from cardiovascular causes — was lower for patients receiving rivaroxaban compared with those receiving placebo (8.9% versus 10.7%, respectively; hazard ratio 0.84, 95% confidence interval 0.74–0.96; P=0.008). This effect remained when the two rivaroxaban dose groups were analysed separately.
Rivaroxaban use was associated with increased rates of major bleeding not related to coronary artery bypass graft surgery (2.1% versus 0.6%; HR 3.96, CI 2.46–6.38; P<0.001). However, there was no difference in the rates of fatal bleeding between the two groups.
“There is a fine balance in treating ACS patients to reduce ischaemic endpoints while minimising risks of major bleeding,” Mr Wright said, adding that this is the first of the newer oral anticoagulants to show a reduction in ischaemic endpoints and no increase in the risk of fatal bleeding for patients with ACS.
Nevertheless, he believes the results may not be fully applicable in clinical practice, given that more potent antiplatelet drugs (prasugrel and ticagrelor) are being used in preference to clopidogrel for ACS patients. “There will be concerns that adding an anticoagulant to these more potent medicines is untested and may be more likely to result in major bleeding,” he said.
Citation: Clinical Pharmacist URI: 11090881
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