Stopping abelacimab may not be necessary before invasive procedures
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Key takeaways:
- Patients with AF taking abelacimab had very low rates of bleeding when undergoing invasive procedures.
- The results suggest there may not be a need to stop certain anticoagulants before some procedures.
Patients with atrial fibrillation needing stroke prevention assigned to abelacimab had very low rates of bleeding during invasive procedures, according to new data from the AZALEA-TIMI 71 trial.
The results suggest that patients may not need to stop abelacimab (Anthos Therapeutics), a novel factor XI inhibitor, prior to all invasive procedures, Siddharth Patel, MD, investigator from the TIMI Study Group and a cardiologist at Brigham and Women’s Hospital, who presented the results at the European Society of Cardiology Congress, told Healio.
As Healio previously reported, in the main results of the phase 2 AZALEA-TIMI 71 trial, abelacimab, which is not yet approved for commercial use in the United States, reduced risk for major or clinically relevant nonmajor bleeding compared with the direct oral anticoagulant rivaroxaban (Xarelto, Janssen/Bayer).
Potentially changing practice
“Patients with atrial fibrillation tend to be older and tend to have more comorbidities — all factors which makes them more likely to require invasive procedures,” Patel told Healio. “Even dating back to the era of warfarin, the practice had generally been to interrupt anticoagulation. With direct oral anticoagulants, the interruption period is usually 24 to 48 hours. In light of these emerging factor XI inhibitors, which hold promise for providing an even safer platform for anticoagulation, it is an open question for how interruption should be conducted for these invasive procedures.”
For the present substudy, Patel and colleagues analyzed the 441 patients who underwent 920 invasive procedures during the study period. About three-quarters of the procedures were elective, and about three-quarters of the patients who had procedures were at low bleeding risk.
The rate of the primary outcome of periprocedural major or clinically relevant minor bleeding events was very low in both groups, Patel said.
At the procedure level, the primary outcome occurred in 1.2% of procedures with patients assigned abelacimab and 2.2% of procedures in those assigned rivaroxaban (RR = 0.54; 95% CI, 0.19-1.58), while at the patient level, the primary outcome occurred in 0.8% of patients from the abelacimab group and 1.4% of patients from the rivaroxaban group (RR = 0.58; 95% CI, 0.2-1.73), according to the researchers.
In addition, Patel told Healio, among patients who had abelacimab dosed within 30 days of their procedure, the rate of the primary outcome was 0.9%.
Bleeding rates low, comparable
“This is important because abelacimab has a half-life of 28 days,” he told Healio. “It’s a long-acting anticoagulant. Whereas with rivaroxaban, the half-life is 6 to 12 hours, so if you interrupt it, you are essentially going into the procedure off the drug. So it is remarkable that the rates of bleeding were comparable across both treatments.”
While most of the procedures were elective and most of the patients who had them were at low risk for bleeding, “these data are encouraging and suggest that the routine interruption of anticoagulation that we have traditionally done for all oral anticoagulants may not actually be necessary for all procedures with factor XI inhibition, just given the greater safety,” Patel said. “We will need more data, particularly for the non-elective cases and the high bleeding-risk procedures.”
“If these factor XI inhibitors are actually shown to be effective in larger phase 3 studies, this could represent a paradigm shift for how we manage anticoagulation,” he said. “We may encounter a scenario where we don’t end up interrupting anticoagulation prior to a procedure. In fact, we may end up continuing anticoagulation for a majority of procedures, except for those we believe may have the highest risk for bleeding.”
For more information:
Siddharth Patel, MD, can be reached at spatel@bwh.harvard.edu.
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Patel S, et al. Smaller trials, trial updates, and other studies on antiplatelet and antithrombotic therapies. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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