Arrhythmias & electrophysiology

Association of Rivaroxaban vs Apixaban With Major Ischemic or Hemorrhagic Events in Patients With Atrial Fibrillation

JAMAPublished Retrospective cohort study

An erratum to this article was published (JAMA, 5 Apr 2022 ↗)

Authors' conclusion

Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.

Study context

Population
US Medicare beneficiaries ≥65 years with AF starting rivaroxaban or apixaban, 2013–2018
Participants
581,451 beneficiaries474,605 person-years
Exposure
Rivaroxaban vs apixaban
  • Rivaroxabann = 227,572
  • Apixabann = 353,879reference
Outcome
Composite of:
  • Major ischemic (stroke/systemic embolism)
  • Hemorrhagic (intracerebral hemorrhage/other intracranial bleeding/fatal extracranial bleeding) events
Methodological detailsinverse probability of treatment weighting
  • Inverse probability of treatment weighting

Main finding

As reported in the abstract

Rivaroxaban

16.1 per 1000 person-years

Apixaban

13.4 per 1000 person-years

Each group vs apixabanRD, per 1000 person-years (95% CI)
Rivaroxaban
2.7(1.9–3.5)
Each group vs apixabanHazard ratio (95% CI)
Rivaroxaban
1.18(1.12–1.24)

Observational data: associations, not effects.

Secondary outcomes

Per 1000 person-years

OutcomeRivaroxabanApixabanRD (95% CI)
Major ischemic events8.67.61.1 (0.5–1.7)
Fatal ischemic/hemorrhagic events4.53.31.2 (0.8–1.6)
Total mortality44.241.03.1 (1.8–4.5)
Primary outcome, reduced dose (subgroup)27.421.06.4 (4.1–8.7)
Primary outcome, standard dose (subgroup)13.211.41.8 (1.0–2.6)
OutcomeHR (95% CI)
Major ischemic events1.12 (1.04–1.20)
Fatal ischemic/hemorrhagic events1.34 (1.21–1.48)
Total mortality1.06 (1.02–1.09)
Primary outcome, reduced dose (subgroup)1.28 (1.16–1.40)
Primary outcome, standard dose (subgroup)1.13 (1.06–1.21)

Safety

Per 1000 person-years

OutcomeRivaroxabanApixabanRD (95% CI)
Major hemorrhagic events7.55.91.6 (1.1–2.1)
Fatal extracranial bleeding1.41.00.4 (0.2–0.7)
Nonfatal extracranial bleeding39.718.521.1 (20.0–22.3)
OutcomeHR (95% CI)
Major hemorrhagic events1.26 (1.16–1.36)
Fatal extracranial bleeding1.41 (1.18–1.70)
Nonfatal extracranial bleeding2.07 (1.99–2.15)

Original publication

Association of Rivaroxaban vs Apixaban With Major Ischemic or Hemorrhagic Events in Patients With Atrial Fibrillation. JAMA. Published 21 December 2021. doi:10.1001/jama.2021.21222

Composed by AI from the published abstract and checked against it. How Briefs are made →

Get them every week

New studies on this topic in My Week and in your Monday e-mail.

We e-mail you a sign-in link and a code. No password, no spam.