New Blood Thinner Reduces Bleeding Risk in Atrial Fibrillation Patients

Factor XI inhibitors like abelacimab reduce bleeding risks in atrial fibrillation patients more safely than standard anticoagulants.

Patients with atrial fibrillation are often prescribed blood thinners, or anticoagulants, to lower their stroke risk, but many either stop taking them or never receive a prescription because of concerns about potential bleeding risks. Researchers from Mass General Brigham tested a new class of anticoagulants, called Factor XI inhibitors, to treat atrial fibrillation patients in the AZALEA-TIMI 71 Study ().

The trial was halted early on the recommendation of the Data Monitoring Committee after observing a significant reduction in bleeding compared to the standard treatment. According to the findings published in the New England Journal of Medicine, abelacimab, a Factor XI inhibitor, was shown to greatly reduce bleeding compared to the commonly used anticoagulant rivaroxaban.

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Challenges in Treating Atrial Fibrillation

“It should be enormously satisfying to the cardiovascular field, patients and providers that Factor XI inhibitors live up to their promise of superior safety," said Christian Ruff, M.D., MPH, director of General Cardiology within the Cardiovascular Division at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, senior investigator in the TIMI Study Group and principal investigator of the AZALEA-TIMI 71 Study. “Atrial fibrillation is a common medical condition, and bleeding with currently available anticoagulants resulting in significant undertreatment is still one of the greatest shortcomings in cardiovascular disease.”

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Understanding the Stroke Risk in Atrial Fibrillation Patients

About 1-in-3 people will develop atrial fibrillation, making it one of the most common cardiovascular conditions in the world. The risk of stroke increases significantly in patients with atrial fibrillation because blood clots form in the heart chambers and can be pumped to the brain, causing a stroke.

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Comparing Factor XI Inhibitors and Standard Anticoagulants

The AZALEA-TIMI 71 Study is the largest and longest trial examining a Factor XI inhibitor compared to standard of care direct oral anticoagulants to date. The team enrolled 1,287 participants in 95 study sites across the globe. Participants were randomized and administered monthly injections of 150 mg abelacimab, 90 mg abelacimab, or standard dosing of rivaroxaban (20 mg or 15 mg in dose reduced patients).

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Significant Reduction in Bleeding with Abelacimab

The team found that the 150 mg dose of abelacimab reduced bleeding that required hospitalization or medical attention by 62%, compared with rivaroxaban. The 90 mg dose of abelacimab reduced the same types of bleeding by 69%. In addition, the team found that both doses of abelacimab almost eliminated gastrointestinal bleeding compared to rivaroxaban, which is the most common type of bleeding that occurs in patients on currently available anticoagulants.

The team notes that in the AZALEA-TIMI 71 Study, the rates of stroke were low and there were not any significant differences between patients in the abelacimab groups compared to those taking rivaroxaban, although the trial was not powered for ischemic events.

Phase 3 Trial to Test Abelacimab in High-Risk Patients

The TIMI Study Group is leading an ongoing phase 3 trial of the study, LILAC-TIMI 76, which will compare the 150 mg dose of abelacimab to placebo in high-risk atrial fibrillation patients who have been deemed ineligible for current anticoagulants for the prevention of ischemic stroke and systemic embolism.

“The AZALEA-TIMI 71 Study validated that Factor XI inhibitors have an incredibly safe bleeding profile in patients with atrial fibrillation, which is a tremendous potential advance for our patients,” said Ruff. “Now we can shift our attention as we await the results of the phase 3 trials.”

Reference:

Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation - (https://www.nejm.org/doi/10.1056/NEJMoa2406674)

Source-Eurekalert

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Atrial fibrillation is the most common type of arrhythmia, especially in older adults. About 10 percent of people in their 80s have it. #medindia # arrhythmia #heart