Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu klinické zkoušky, fáze II, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
39842011
DOI
10.1056/nejmoa2406674
Knihovny.cz E-zdroje
- MeSH
- antikoagulancia * aplikace a dávkování škodlivé účinky MeSH
- aplikace orální MeSH
- cévní mozková příhoda epidemiologie etiologie prevence a kontrola MeSH
- dvojitá slepá metoda MeSH
- faktor XI analýza antagonisté a inhibitory MeSH
- fibrilace síní * krev komplikace farmakoterapie MeSH
- humanizované monoklonální protilátky * aplikace a dávkování škodlivé účinky MeSH
- incidence MeSH
- inhibitory faktoru Xa * aplikace a dávkování škodlivé účinky MeSH
- injekce subkutánní MeSH
- krvácení * chemicky indukované diagnóza epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- rivaroxaban * aplikace a dávkování škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- abelacimab MeSH Prohlížeč
- antikoagulancia * MeSH
- faktor XI MeSH
- humanizované monoklonální protilátky * MeSH
- inhibitory faktoru Xa * 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.).
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT04755283