Abelacimab Shows Promise in Reducing Bleeding Risks for High-Risk Patients | ACC 2025

The AZALEA-TIMI 71 clinical trial that compares abelacimab to Xarelto (rivaroxaban) has brought the solely generic-named abelacimab into the spotlight as a promising alternative to rivaroxaban for anticoagulation therapy, a treatment that prevents blood clots from forming or growing.

However, questions remain about how it compares to other direct oral anticoagulants (DOACs) in terms of bleeding risk.

In an interview with Managed Healthcare Executive, Christian T. Ruff, M.D., M.P.H., director of general cardiology at Brigham and Women's Hospital and associate professor at Harvard Medical School, addressed this uncertainty and highlighted abelacimab’s significant safety profile.

“Without a head-to-head trial, it's hard to answer that question exactly, but I certainly believe abelacimab is far safer, not only than rivaroxaban but than any other DOAC, at least on the clinical trial data that we have,” he stated.

While rivaroxaban was the other drug being compared in the trial, Ruff pointed out that the differences in bleeding risk between other DOACs are relatively minor.

The 60 to 70% reduction in bleeding found with abelacimab compared to rivaroxaban suggests an improvement in safety, which could extend to other DOACs as well.

A major area of interest is the population of patients at high risk of bleeding who currently receive no anticoagulation therapy at all.

Ruff said this area of interest represents a significant unmet need.

“I think it would be in the 40% of patients who aren't getting anything, because that's the biggest unmet need—they're totally unprotected from stroke,” he shared.

To address this, the ongoing LILAC-TIMI 76 trial, which is in phase 3, is evaluating abelacimab in this high-risk group.

In addition, abelacimab is also being tested against apixaban in patients with cancer-associated venous thromboembolism (VTE).

This is another high-risk group where existing DOACs don't offer enough benefits due to the high risks of thrombosis and recurrent bleeding, Ruff said.

Although abelacimab has displayed positive safety benefits in the AZALEA-TIMI 71 trial, Ruff suggests that further studies against other DOACs are necessary, as they will help determine whether factor XI inhibition should become a standard approach for anticoagulation in atrial fibrillation and other high-risk conditions.