What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation with moderate or severe chronic kidney disease (n=313). Intervention: Rivaroxaban vs. Warfarin. Primary outcome: Major bleeding (HR 0.34, 95% CI 0.17-0.71, p=0.004).

What question did this study set out to answer?

To compare the effectiveness and safety of rivaroxaban versus warfarin in patients with atrial fibrillation and varying degrees of renal impairment.

July 1, 2023Heart Views1 citationsOpen Access

Real-world Experience in Managing Atrial Fibrillation in Patients with Renal Impairment; Rivaroxaban versus Warfarin

Q: What does this research mean for the field?

Warfarin use significantly lowers the risk of major bleeding compared to rivaroxaban in patients with atrial fibrillation and moderate to severe chronic kidney disease, while maintaining similar stroke rates. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

MAMonirah Abdulrahman AlbabtainPrince Sultan University ZAZaid Dakheel AlanaziPrince Sultan University NANawaf Hamoud Al-MutairiPrince Sultan University

Key Result

Warfarin use significantly lowered the risk of major bleeding (HR 0.34) compared to rivaroxaban in patients with atrial fibrillation and moderate to severe chronic kidney disease.

Key Points

To compare the effectiveness and safety of rivaroxaban versus warfarin in patients with atrial fibrillation and varying degrees of renal impairment.
Retrospective study conducted between 2015 and 2016.
Included 164 patients treated with warfarin and 149 patients treated with rivaroxaban.
Outcomes included survival, stroke, and major bleeding events with a median follow-up of 50 months.
Major bleeding occurred in 36 patients, 24 on rivaroxaban and 12 on warfarin (P=0.01).
Hazard ratio for warfarin lowering the risk of bleeding was 0.34 (P=0.004).
Survival rates at 1, 3, and 5 years were higher for rivaroxaban (99%, 94%, 88%) compared to warfarin (89%, 77%, 71%) with P<0.001.

Study Design

Type

Cohort (n=313)

Multicenter

Structured PICO

Does rivaroxaban improve survival, stroke, and major bleeding compared to warfarin in patients with atrial fibrillation and moderate or severe renal impairment?

Population

313 patients requiring anticoagulation therapy for atrial fibrillation with moderate or severe renal impairment (creatinine clearance < 50 mL/min). Excluded: normal renal function or mild renal impairment, mechanical heart valves, or on NOACs other than rivaroxaban.

Intervention

Rivaroxaban

Comparator

Warfarin (target international normalization ratio between 2 and 3)

Outcome

Survival, stroke, and major bleeding (defined using the Bleeding Academic Research Consortium definition)hard clinical

In patients with atrial fibrillation and moderate-to-severe chronic kidney disease, warfarin was associated with fewer major bleeding events but higher mortality compared to rivaroxaban, highlighting the complex trade-offs in anticoagulation for this population.

Main Result

Effect estimate: HR 0.34 (95% CI 0.17-0.71)

Absolute Event Rate: 16.11% vs 7.32%

p-value: p=0.004

Limitations

Single-center experience that may not apply to other centers
Retrospective design liable to selection and referral biases
Several confounders that might have affected the outcomes were excluded from the analysis

Abstract

Background: The use of rivaroxaban in patients with atrial fibrillation (AF) and chronic kidney disease (CKD) poses the risk of over- or underdosing. We aimed to compare rivaroxaban and warfarin in AF patients with moderate and severe renal impairment. Methods: This retrospective study was conducted between 2015 and 2016 to compare the use of warfarin ( n = 164) and rivaroxaban ( n = 149) in patients with AF and moderate or severe CKD. The study outcomes were survival, stroke, and major bleeding events. The median follow-up was 50 months (interquartile range: 23–60). Results: Thirty-six patients had major bleeding: 24 with rivaroxaban and 12 with warfarin ( P = 0.01). The rivaroxaban group had major bleeding in 3 patients with moderate CKD, 4 with severe CKD, and 17 on dialysis. Multivariable analysis of factors affecting major bleeding revealed that warfarin use lowered the risk of bleeding (hazard ratio: 0.34; P = 0.004). Stroke occurred in 14 patients: 6 in the rivaroxaban group and 8 in the warfarin group ( P = 0.44). Survival at 1, 3, and 5 years was 89%, 77%, and 71% with warfarin and 99%, 94%, and 88% with rivaroxaban, respectively ( P < 0.001). Multivariable analysis showed higher mortality in patients with lower creatinine clearance and those on warfarin. Conclusions: The safety of warfarin could be better than rivaroxaban in patients with CKD with fewer bleeding complications but similar stroke rates. Further studies on rivaroxaban dosing in patients on dialysis are required.

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