What is the clinical evidence from this study?

Study design: RCT. Population: Atrial Fibrillation and Chronic Kidney Disease (n=176). Intervention: Apixaban vs. Warfarin. Primary outcome: Incidence of major bleeding within 3 months of enrolment (p=0.25).

October 1, 2023Open Access

Efficacy and Safety of Apixaban Versus Warfarin in Patients with Atrial Fibrillation and Chronic Kidney Disease: A Randomised Controlled Trial

Key Result

Apixaban did not significantly reduce the incidence of major bleeding within 3 months compared to warfarin in patients with atrial fibrillation and stage 3-5 chronic kidney disease (9.1% vs 15.9%, p=0.25).

Study Design

Type

RCT (n=176)

Blinding

Open-label

Randomization

Web generated random numbers

Multicenter

Structured PICO

Does apixaban reduce major bleeding, stroke, and thromboembolism compared to warfarin in patients with atrial fibrillation and stage 3-5 chronic kidney disease?

Population

Patients with atrial fibrillation and stage 3-5 chronic kidney disease (not on haemodialysis)

Intervention

Apixaban (doses adjusted based on ACC guidelines)

Comparator

Warfarin (doses adjusted based on ACC guidelines)

Outcome

Incidence of major bleeding within 3, 6, and 12 months, and incidence of ischemic stroke and thromboembolism within 12 monthshard clinical

In patients with atrial fibrillation and stage 3-5 chronic kidney disease, apixaban significantly reduces major bleeding compared to warfarin at 12 months.

Main Result

Absolute Event Rate: 9.1% vs 15.9%

p-value: p=0.25

Limitations

Single-center, open-label design
Failed to clarify the impact of apixaban dose on the relationship between renal function and outcomes
Some patients received the wrong dosage (underdose), making it impossible to establish an accurate dose-bleeding association
Low frequency of use of oral anti-coagulants in patients with eGFR >60 ml/min/1.73 m2 limited comparisons in that subgroup

Abstract

Introduction:The most prevalent form of cardiac arrhythmia, atrial fibrillation (AF), is an important contributor in cerebral ischemic stroke and other serious thromboembolic complications.Current recommendations state that DOACs (direct oral anticoagulants) rather than vitamin K inhibitors should be provided to atrial fibrillation patients at risk (CHA2DS2VASc scores greater than or equal to 2) to prevent these serious consequences.It is still unclear if apixaban medication is beneficial for those with chronic kidney disease (CKD) who are not on haemodialysis.Aims/ objective: To compare the efficacy and safety of apixaban and warfarin in patients with atrial fibrillation and stage 3-5 CKD and to compare the relative risks of stroke, thromboembolism, and major bleeding between two groups. Materials and Method:Consecutive sampling was done and each patient of AF and CKD fulfilling our eligibility criteria were allocated either to apixaban or warfarin group using web generated random numbers.Doses of anticoagulation therapy was adjusted based on ACC (American College of Cardiology) guidelines.Incidence of major bleeding within 3 months of enrolment and within 6 and 12 months of follow-up, incidences of ischemic stroke and thromboembolism within 12 months, and TTR (time in therapeutic range of INR between 2.0 and 3.0) at 12 months were compared between two groups.Results: Incidence of major bleeding was lower in patients receiving apixaban as compared to patients on warfarin therapy and the difference became significant at 12 months (p<0.05).Patients receiving apixaban spent more time in therapeutic range of INR (2.0-3.0) as compared to patients on warfarin therapy and the difference comes out to be statistically significant (p<0.0001).Patients in stage 5 CKD also had TTR more than 60% in apixaban group.Incidence of stroke and thromboembolism was also lower but not statistically significant. Conclusion:In conclusion, patients with atrial fibrillation who received apixaban therapy had a lower incidence of stroke or thrombosis than those who were given warfarin, and those with stage 4 and stage 5 CKD were also benefited from apixaban.

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