Key result
Apixaban fails to reduce major bleeding vs warfarin in AF and stage 3-5 CKD.
Why the study?
It remained unclear whether apixaban is beneficial for patients with atrial fibrillation and chronic kidney disease who are not on haemodialysis.
Does apixaban reduce major bleeding, stroke, and thromboembolism compared to warfarin in patients with atrial fibrillation and stage 3-5 chronic kidney disease?
RCT (n=176)
Open-label
Web generated random numbers
No
Does apixaban reduce major bleeding, stroke, and thromboembolism compared to warfarin in patients with atrial fibrillation and stage 3-5 chronic kidney disease?
Absolute Event Rate: 9.1% vs 15.9%
p-value: p=0.25
In patients with atrial fibrillation and stage 3-5 chronic kidney disease, apixaban significantly reduces major bleeding compared to warfarin at 12 months.
Does not support short-term preference for apixaban over warfarin in AF with stage 3-5 CKD; leaves open longer-term safety and dedicated trials.
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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Chandra et al. (2023) conducted an RCT in Atrial Fibrillation and Chronic Kidney Disease (n=176). Apixaban vs. Warfarin was evaluated on Incidence of major bleeding within 3 months of enrolment (p=0.25). 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).
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