What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial Fibrillation and Chronic Kidney Disease (n=724). Intervention: Severe non-dialysis dependent chronic kidney disease (eGFR 60 ml/min). Primary outcome: Stroke or TIA (HR 2.75, 95% CI 1.25-6.05).

What does this research mean for the field?

Patients with severe non-dialysis dependent chronic kidney disease receiving vitamin K-antagonists for atrial fibrillation have a significantly increased risk of stroke, transient ischemic attack, and major bleeding compared to those with mild or no renal impairment. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

May 9, 2014PLoS ONEOpen Access

Efficacy and Safety of Vitamin K-Antagonists (VKA) for Atrial Fibrillation in Non-Dialysis Dependent Chronic Kidney Disease

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Key result

Severe CKD linked to ~175% higher stroke or TIA risk during VKA therapy for AF.

HR 2.75
95% CI 1.25-6.05
n=724

Why the study?

Essential information regarding efficacy and safety of vitamin K-antagonists treatment for atrial fibrillation in non-dialysis dependent chronic kidney disease is still lacking.

Does severe CKD increase the risk of stroke, TIA, or major bleeding in patients with atrial fibrillation treated with vitamin K-antagonists compared to those with moderate or no CKD?

Population

724 patients with atrial fibrillation on vitamin K-antagonists including 300 without CKD, 294 with moderate CKD, and 130 with severe non-dialysis dependent CKD

Comparison

Vitamin K-antagonists in patients with severe non-dialysis dependent CKD versus patients without CKD or with moderate CKD

Design

Cohort study with uni- and multivariate Cox regression analyses

Authors

JKJudith KooimanErasmus MC NRNienke van ReinLeiden University BSBas SpaansLeiden University Medical Center

Discussion

Member takes

Implication

May warrant VKA caution in severe CKD-AF; leaves open optimal agent selection in prospective trials.

Study Design

Type

Cohort (n=724)

Multicenter

Yes

Structured PICO

Does severe CKD increase the risk of stroke, TIA, or major bleeding in patients with atrial fibrillation treated with vitamin K-antagonists compared to those with moderate or no CKD?

Population

724 patients with atrial fibrillation starting vitamin K-antagonist therapy, including 130 with severe non-dialysis dependent chronic kidney disease, followed for a median of 2.1 years.

Exposure

Vitamin K-antagonists (VKA) in patients with severe non-dialysis dependent CKD

Comparator

Vitamin K-antagonists (VKA) in patients without CKD or with moderate CKD

Outcome

Stroke or transient ischemic attack (TIA) and major bleedshard clinical

Main Result

Hazard Ratio: 2.75 (95% CI 1.25–6.05)

Absolute Event Rate: 4.24% vs 1.62%

VKA treatment in AF patients with severe non-dialysis dependent CKD is associated with poor efficacy and safety, highlighting the need for individualized anticoagulation strategies in this high-risk population.

Limitations

No information on alterations in renal function during follow-up, which might have led to misclassification.
Events were recorded from chart review, so some events may have been missed.
Primary and secondary outcomes were not adjudicated by an independent committee.
Sample size was too small to make further subdivisions in the stages of CKD or demonstrate statistical differences in fatal MACE and bleeding rates.
Did not investigate the influence of co-medication interacting with VKAs on study outcomes.
Missing serum creatinine values at time of VKA initiation in 19.6% of the original cohort.

Cite This Study

Kooiman et al. (2014) conducted a cohort in Atrial Fibrillation and Chronic Kidney Disease (n=724). Severe non-dialysis dependent chronic kidney disease (eGFR <30 ml/min) vs. No chronic kidney disease (eGFR >60 ml/min) was evaluated on Stroke or TIA (HR 2.75, 95% CI 1.25-6.05). Severe non-dialysis dependent chronic kidney disease was associated with a significantly increased risk of stroke or TIA (HR 2.75) during vitamin K-antagonist treatment for atrial fibrillation compared to patients without renal impairment.

synapsesocial.com/papers/6aacbc00ee51e0d83f1ef4a8 https://doi.org/10.1371/journal.pone.0094420

Topics

Atrial fibrillation Persistent AF management Anticoagulation in AF

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Efficacy and Safety of Vitamin K-Antagonists (VKA) for Atrial Fibrillation in Non-Dialysis Dependent Chronic Kidney Disease

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Efficacy and Safety of Vitamin K-Antagonists (VKA) for Atrial Fibrillation in Non-Dialysis Dependent Chronic Kidney Disease

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider