Secondary analysis confirms safety of blood thinning agent

February 21, 2020

LOS ANGELES, Feb. 21, 2020 -- Treatment with the blood thinner apixaban was associated with a lower risk of bleeding, death and hospitalization compared with warfarin, regardless of history of prior stroke or blood clot, according to a secondary analysis presented as late breaking science today at the American Stroke Association's International Stroke Conference 2020. The conference, Feb. 19-21 in Los Angeles, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

The AUGUSTUS trial, first published in March 2019, found that treatment with apixaban without aspirin resulted in less bleeding and fewer deaths and hospitalizations than treatment with a vitamin K antagonist (like warfarin) plus aspirin among patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention treated with a P2Y12 inhibitor. The current study is a secondary analysis of the efficacy and safety outcomes 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," said lead study author Maria Cecilia Bahit, M.D., 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."

In the AUGUSTUS trial - a global, multi-center study - 4,614 patients with atrial fibrillation and an acute coronary syndrome or those under­going percutaneous coronary intervention (PCI) with planned treatment with a P2Y12 inhibitor were randomly assigned to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for six months. Of the 4,581 patients with information available about prior stroke, 13.8% had prior stroke/transient ischemic attack or thromboembolism.

This analysis found:

Patients with prior stroke were at increased risk of ischemic stroke, bleeding, hospitalization or death compared with those with no prior stroke;

Apixaban without aspirin was associated with the lowest rate of bleeding, death or hospitalization, regardless of history of prior stroke;

The highest rate of bleeding was seen in patients who received the combination of a vitamin K antagonist plus aspirin;

The risk of bleeding was higher with aspirin than placebo among patients with no prior events; and

There was no significant difference between aspirin and placebo observed between patients with and without prior stroke for other clinical outcomes.

"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," said Bahit.
-end-
The list of study authors and disclosures are available in the abstract. The AUGUSTUS trial was funded by Bristol-Myers Squibb and Pfizer, Inc.

Additional Resources:

VIDEO Perspective from Mitchell S. V. Elkind, M.D., M.S., FAHA, FAAN, president elect of the American Heart Association, may be downloaded on the right column of the release link along with any additional, available multimedia. https://newsroom.heart.org/news/secondary-analysis-confirms-safety-of-blood-thinning-agent?preview=e832e9c798b5b0e4bc9a8cfde25cbea4

Updated treatment guidelines for atrial fibrillation recommend a new class of blood thinners to help prevent stroke
For more news at ASA International Stroke Conference 2020, follow us on Twitter @HeartNews #ISC20.

Statements and conclusions of study authors that are presented at American Stroke Association scientific meetings are solely those of the study authors and do not necessarily reflect Association policy or position. The Association makes no representation or warranty as to their accuracy or reliability. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at https://www.heart.org/en/about-us/aha-financial-information.

The American Stroke Association's International Stroke Conference (ISC) is the world's premier meeting dedicated to the science of stroke and brain health. ISC 2020 will be held February 19-21 at the Los Angeles Convention Center in California. The 2 ½-day conference features more than 1,600 compelling scientific presentations in 21 categories that emphasize basic, clinical and translational science for health care professionals and researchers. These science and other clinical presentations will provide attendees with a better understanding of stroke and brain health to help improve prevention, treatment and outcomes for the more than 800,000 Americans who have a stroke each year. Stroke is the fifth leading cause of death and a leading cause of serious, long-term disability in the U.S. Worldwide, cerebrovascular accidents (stroke) are the second leading cause of death and the third leading cause of disability, according to the World Health Organization. Engage in the International Stroke Conference on social media via #ISC20.

About the American Stroke Association

The American Stroke Association is a relentless force for a world with fewer strokes and longer, healthier lives. We team with millions of volunteers and donors to ensure equitable health and stroke care in all communities. We work to prevent, treat and beat stroke by funding innovative research, fighting for the public's health, and providing lifesaving resources. The Dallas-based association was created in 1998 as a division of the American Heart Association. To learn more or to get involved, call 1-888-4STROKE or visit strokeassociation.org. Follow us on Facebook and Twitter.

American Heart Association

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