Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation
Language English Country United States Media print
Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
39842011
DOI
10.1056/nejmoa2406674
Knihovny.cz E-resources
- MeSH
- Anticoagulants * administration & dosage adverse effects MeSH
- Administration, Oral MeSH
- Stroke epidemiology etiology prevention & control MeSH
- Double-Blind Method MeSH
- Factor XI analysis antagonists & inhibitors MeSH
- Atrial Fibrillation * blood complications drug therapy MeSH
- Antibodies, Monoclonal, Humanized * administration & dosage adverse effects MeSH
- Incidence MeSH
- Factor Xa Inhibitors * administration & dosage adverse effects MeSH
- Injections, Subcutaneous MeSH
- Hemorrhage * chemically induced diagnosis epidemiology MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Rivaroxaban * administration & dosage adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- abelacimab MeSH Browser
- Anticoagulants * MeSH
- Factor XI MeSH
- Antibodies, Monoclonal, Humanized * MeSH
- Factor Xa Inhibitors * MeSH
- Rivaroxaban * MeSH
BACKGROUND: Abelacimab is a fully human monoclonal antibody that binds to the inactive form of factor XI and blocks its activation. The safety of abelacimab as compared with a direct oral anticoagulant in patients with atrial fibrillation is unknown. METHODS: Patients with atrial fibrillation and a moderate-to-high risk of stroke were randomly assigned, in a 1:1:1 ratio, to receive subcutaneous injection of abelacimab (150 mg or 90 mg once monthly) administered in a blinded fashion or oral rivaroxaban (20 mg once daily) administered in an open-label fashion. The primary end point was major or clinically relevant nonmajor bleeding. RESULTS: A total of 1287 patients underwent randomization; the median age was 74 years, and 44% were women. At 3 months, the median reduction in free factor XI levels with abelacimab at a dose of 150 mg was 99% (interquartile range, 98 to 99) and with abelacimab at a dose of 90 mg was 97% (interquartile range, 51 to 99). The trial was stopped early on the recommendation of the independent data monitoring committee because of a greater-than-anticipated reduction in bleeding events with abelacimab. The incidence rate of major or clinically relevant nonmajor bleeding was 3.2 events per 100 person-years with 150-mg abelacimab and 2.6 events per 100 person-years with 90-mg abelacimab, as compared with 8.4 events per 100 person-years with rivaroxaban (hazard ratio for 150-mg abelacimab vs. rivaroxaban, 0.38 [95% confidence interval {CI}, 0.24 to 0.60]; hazard ratio for 90-mg abelacimab vs. rivaroxaban, 0.31 [95% CI, 0.19 to 0.51]; P<0.001 for both comparisons). The incidence and severity of adverse events appeared to be similar in the three groups. CONCLUSIONS: Among patients with atrial fibrillation who were at moderate-to-high risk for stroke, treatment with abelacimab resulted in markedly lower levels of free factor XI and fewer bleeding events than treatment with rivaroxaban. (Funded by Anthos Therapeutics; AZALEA-TIMI 71 ClinicalTrials.gov number, NCT04755283.).
References provided by Crossref.org
ClinicalTrials.gov
NCT04755283