Reversal agent decreases life-threatening bleeding

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.

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.