Reversal agent decreases life-threatening bleeding

American Stroke Association Late Breaking News Brief – Abstract LB 7, Session MEII Thursday Main Event

HONOLULU, Feb. 7, 2019 — A drug that reverses the blood thinning effects of factor Xa inhibitors effectively stopped acute life-threatening bleeding in patients taking a factor Xa inhibitor blood thinner drug, according to late breaking science presented at the American Stroke Association’s International Stroke Conference 2019, a world premier meeting for researchers and clinicians dedicated to the science and treatment of cerebrovascular disease.

The study will be simultaneously published in the New England Journal of Medicine.

Factor Xa inhibitor blood thinners (apixaban, rivaroxaban, or edoxaban, which are direct factor Xa inhibitors) and enoxaparin are used to prevent blood clots but can also cause or worsen serious bleeding. The agent andexanet alfa is designed to rapidly neutralize the anticoagulant effects of blood thinners in the event of acute bleeding. Researchers investigated if andexanet alfa could decrease the effect of the blood thinner and decrease bleeding assessed 12 hours after administering the reversal agent.

A total of 352 patients (average age 77, 53 percent male) were enrolled from 86 sites worldwide, after presenting to emergency rooms with primarily gastrointestinal bleeding or brain bleeding. Researchers said good or excellent hemostasis (the stopping of bleeding) occurred in 81.7 percent of patients.

“The study supported the May 2018 FDA approval of andexanet alfa, now the only approved agent for patients taking rivaroxaban and apixaban when urgent reversal is needed for life-threatening or uncontrolled bleeding, said senior author Truman J. Milling Jr., M.D., associate professor, Department of Neurology and associate professor, Department of Surgery and Perioperative Care at Seton Dell Medical School Stroke Institute in Austin, Texas.

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Co-authors and disclosures are listed on the abstract.

Portola Pharmaceuticals funded the study.

Note: Scientific presentation is 11:36 a.m. Hawaii Time/4:36 p.m. Eastern Time, Thursday, Feb. 7, 2019.

Additional Resources:

* VIDEO: Miguel Perez-Pinzon, Ph.D., FAHA, Chair, International Stroke Conference 2019 Program Committee, offers overviews and perspective on late breaking science via downloadable Skype video (transcript provided) available on the right column of the release link https://newsroom.heart.org/news/reversal-agent-decreases-life-threatening-bleeding?preview=d80d5292b140ebcb55f8965a876e4e9e

* 2016 AHA/ASA News Release: New drug reverses the effects of blood thinner in patients with brain hemorrhage

* For more news from AHA International Stroke Conference 2019, follow us on Twitter @HeartNews #ISC19.

Statements and conclusions of study authors that are presented at American Heart 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.

About the American Stroke Association

The American Stroke Association is devoted to saving people from stroke — the No. 2 cause of death in the world and a leading cause of serious disability. We team with millions of volunteers to fund innovative research, fight for stronger public health policies and provide lifesaving tools and information to prevent and treat stroke. The Dallas-based association officially launched 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.

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