New Drugs and Devices From 2011 – 2012 That Might Change Your Practice

Joe Lex, MD


Western J Emerg Med. 2013;14(6):619-628. 

In This Article

Eliquis® (Apixaban)

Apixaban is another direct factor Xa inhibitor that has been available in Europe since May 2012. It barely made it under the wire for 2012, being approved by the FDA on 28 December for reducing the risk of stroke and systemic embolism in patients with AF that is not caused by a heart valve problem.

ARISTOTLE was a head-to-head study of apixaban 5 mg twice daily versus warfarin in patients with AF involving 18,201 patients in 1,034 clinical sites in 39 countries. The primary efficacy outcome was stroke or systemic embolism, analyzed by intention to treat. The primary safety outcome was major bleeding in the on-treatment population. Apixaban was not inferior to warfarin in the primary endpoint, and was superior in avoiding major bleeding (a key secondary endpoint). Time within the therapeutic range was mean 62%. See Table 1 for results.

The downside of apixaban is the same as for rivaroxaban. No reversal agent is available for the exsanguinating patient. A trial scheduled to be evaluated in March 2013 (Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism) will give us information about whether apixaban can be used for outpatient treatment of VTE. Then, of course, we will need to see a head-to-head trial of rivaroxaban versus apixaban versus warfarin.