Research highlights:
- Bleeding was reduced by more than 60% in people taking the anticoagulant avelacimab, proving that avelacimab is safe for people at risk of stroke due to atrial fibrillation.
- A study of more than 1,200 people at moderate to high risk of stroke due to irregular heart rhythms compared abelacimab and another standard-of-care anticoagulant, rivaroxaban, in terms of incidence of bleeding. .
- The trial was halted in early September 2023 due to an “overwhelming reduction” in bleeding with abelacimab.
Embargoed until Sunday, November 12, 2023 at 8:15 a.m. ET
PHILADELPHIA, November 12, 2023 — The experimental anticoagulant drug abelacimab significantly reduces bleeding in people with the following conditions: Atrial fibrillation (or AFib) People at risk for stroke, according to results from the AZALEA-TIMI 71 trial presented today as Latest Science at the American Heart Association. Academic Session 2023. The conference, to be held in Philadelphia from November 11-13, is the premier global gathering to exchange updates on the latest scientific advances, research, and evidence-based clinical practice in cardiovascular science. .
“This study supports the possibility that avelacimab is a very safe anticoagulant for stroke prevention in patients with atrial fibrillation,” said the researcher, director of general cardiology at Brigham and Women’s Hospital in Boston. said author Christian T. Ruff, MD, MPH. He is a member of the TIMI group and an associate professor at Harvard Medical School.
The AZALEA-TIMI 71 trial was stopped prematurely in September 2023 on the recommendation of an independent data monitoring committee due to the “overwhelming reduction” in bleeding with abelacimab compared to the anticoagulant rivaroxaban. .
This is the first top-line analysis of Phase 2 of a multinational trial in 1,287 people taking abelacimab (a factor The occurrence of bleeding was compared. Oral anticoagulant or anticoagulant rivaroxaban. This is the longest and largest trial to date comparing factor XI inhibitors to the current standard of care, direct-acting oral anticoagulants.
The analysis found that avelacimab significantly reduced bleeding in patients with atrial fibrillation compared to rivaroxaban. Specifically, the details are as follows.
- Abelacimab reduced major bleeding that would normally require hospitalization and bleeding that required medical attention but not hospitalization by 67% at the 150 mg dose and 77% at the 90 mg dose compared to rivaroxaban. I was allowed to.
- At a dose of 150 mg, abelacimab reduced major bleeding by 74% compared to rivaroxaban. At the 90 mg dose, major bleeding was reduced by 81%.
- Both doses of abelacimab reduced gastrointestinal bleeding by 93% compared to rivaroxaban.
- Abelacimab was well tolerated with similar adverse event rates compared to rivaroxaban.
“Assuming data from ongoing phase 3 trials confirm the benefit of factor XI inhibitors for stroke prevention in patients with atrial fibrillation, that could be truly transformative for the field of cardiology,” Ruff said said. “Our first mission in treating patients with atrial fibrillation is to prevent stroke, and being able to do this with an extremely safe anticoagulant like abelacimab is an incredible advance. I guess.”
According to the report, people with atrial fibrillation have an approximately five times higher risk of stroke than people without arrhythmia. american heart association. Typically, medical professionals would prescribe blood thinners, or blood thinners, to reduce the risk of stroke by limiting the body’s ability to form blood clots, Ruff said. However, these issues impact who can safely take anticoagulants, as anticoagulants carry a high risk of bleeding, which can be life-threatening or cause patients to discontinue treatment. Masu.
Trial details and background:
- Avelacimab is an injectable monoclonal antibody classified as a factor there is. This may reduce the risk of bleeding for users.
- The study enrolled 1,287 adults at 95 global research sites, including the United States, Canada, Europe, and Asia, from March to December 2021, with a median follow-up of 1.8 years.
- Participants were over 55 years old (44% female) with a history of atrial fibrillation and taking anticoagulants.
- Participants were at moderate to high risk of stroke as determined by congestive heart failure, high blood pressure, age, type 2 diabetes, stroke, and history of vascular disease known as CHA.2DS2-VASc score.
- A 2021 study showed that abelacimab effectively prevented blood clots in people who had knee replacement surgery.
Co-authors, disclosures, and funding sources are listed in the abstract.
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