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AUGUSTUS: Dual surpasses triple therapy when AFib patients have PCI or ACS

Key clinical point: For atrial fibrillation patients with either a recent acute coronary syndrome or percutaneous coronary intervention, treatment with apixaban plus clopidogrel was associated with the best overall results.

Major finding: Significant bleeds occurred in 7% of patients on apixaban plus clopidogrel and in 19% on aspirin, warfarin, and clopidogrel.

Study details: AUGUSTUS, a multicenter, randomized trial with 4.614 patients.

Disclosures: AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that market apixaban (Eliquis). Dr. Lopes has received personal fees and research grants from BMS and Pfizer. He has also received personal fees from Bayer and Boehringer Ingelheim and research grants from Amgen, GlaxoSmithKline, Medtronic, and Sanofi Aventis. Dr. Alexander has received personal fees from Bristol-Myers Squibb and Pfizer, and from several other companies, and he has received research grants from BMS and several other companies.

Citation:

Lopes RD et al. N Engl J Med. 2019 Mar 17. doi: 10.1056/NEJMoa1817083.

Commentary:

Findings hammer a nail in the coffin for warfarin plus aspirin

It’s very reassuring to see that you can use a direct-acting oral anticoagulant like apixaban along with a P2Y12 inhibitor, but with no aspirin, and have no statistically significant increase in ischemic events. This is a fantastic finding. The finding shows once again that warfarin is a problematic drug. As the cost for direct-acting oral anticoagulants has decreased, their use has increased.

These results were not unexpected and also are probably the final nail in the coffin for using a combination of warfarin and aspirin. Prior findings from the PIONEER AF-PCI study that used rivaroxaban (N Engl J Med. 2016 Dec 22;375[25]:2423-34) and from the RE-DUAL PCI study that used dabigatran (N Engl J Med. 2017 Oct 19;377[16]:1513-24) also showed the advantages of using a direct-acting oral anticoagulant when compared with a vitamin K antagonist in this setting, The AUGUSTUS trial, with just over 4,600 patients, had nearly as many patients as the roughly 4,850 enrolled in these two prior studies put together.

Dhanunjaya Lakkireddy, MD , is medical director of the Kansas City Heart Rhythm Institute in Overland Park. He had no disclosures. He made these comments as the designated discussant during a press briefing.