Los Angeles—Despite concerns about history of stroke or blood clot, patients treated with the blood thinner apixaban had a lower risk of bleeding, death, and hospitalization compared with warfarin, according to a late-breaking presentation at the American Stroke Association’s International Stroke Conference 2020.

The presentation was based on secondary analysis of the AUGUSTUS trial, first published in March 2019. The original study determined that treatment with apixaban without aspirin resulted in less bleeding and fewer deaths and hospitalizations than treatment with a vitamin K antagonist plus aspirin among patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention treated with a P2Y12 inhibitor.

The current study focused on the efficacy and safety of those treatments. “We divided the AUGUSTUS study population into two groups: patients with prior stroke/transient ischemic attack/thromboembolism and those with no prior stroke/transient ischemic attack /thromboembolism,” explained lead author Maria Cecilia Bahit, MD, chief of cardiology at INECO Neurociencias in Rosario, Santa Fe, Argentina. “Apixaban was safer than warfarin—causing less major bleeding—and more effective, resulting in less death or hospitalization in both groups.”

Of the 4,581 patients in the AUGUSTUS trial with information available about prior stroke, 13.8% had prior stroke/transient ischemic attack (TIA) or thromboembolism (TE). Analysis of their cases revealed:
• Patients with prior stroke were at increased risk of ischemic stroke, bleeding, hospitalization or death compared with those without that history
• Apixaban without aspirin was associated with the lowest rate of bleeding, death, or hospitalization, even in patients with prior stroke
• The highest bleeding rate was observed in patients who concurrently received a vitamin K antagonist and aspirin
• Bleeding risk was higher with aspirin than with placebo among patients with no prior events, and
• No significant differences between aspirin and placebo were observed for other clinical outcomes between patients with and without prior stroke .

“These results reinforce the main results of the AUGUSTUS trial by assuring physicians that even in a high-risk group of patients with prior stroke ‘less is more.’ In other words, a strategy of apixaban plus a P2Y12 inhibitor without aspirin has the most favorable outcomes, and triple therapy—a vitamin K antagonist plus aspirin plus a P2Y12 inhibitor—should be avoided,” Dr. Bahit emphasized.

The study concludes that the “safety and efficacy of apixaban compared with a vitamin K antagonist was consistent with the overall trial findings, irrespective of history of prior stroke/TIA/TE.” It also notes that aspirin increased bleeding, especially in patients without prior stroke/TIA/TE.

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