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Randomized Controlled Trial
. 2015 Jun 16;65(23):2481-93.
doi: 10.1016/j.jacc.2015.03.577.

Changes in Renal Function in Patients With Atrial Fibrillation: An Analysis From the RE-LY Trial

Michael Böhm  1 , Michael D Ezekowitz  2 , Stuart J Connolly  3 , John W Eikelboom  3 , Stefan H Hohnloser  4 , Paul A Reilly  5 , Helmut Schumacher  6 , Martina Brueckmann  7 , Stephan H Schirmer  8 , Mario T Kratz  8 , Salim Yusuf  3 , Hans-Christoph Diener  9 , Ziad Hijazi  10 , Lars Wallentin  10
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Free article
Randomized Controlled Trial

Changes in Renal Function in Patients With Atrial Fibrillation: An Analysis From the RE-LY Trial

Michael Böhm et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Vitamin K-dependent factors protect against vascular and renovascular calcification, and vitamin K antagonists may be associated with a decreased glomerular filtration rate (GFR).

Objectives: This study analyzed changes in GFR during long-term treatment with warfarin or dabigatran etexilate (DE) in patients enrolled in the RE-LY (Randomized Evaluation of Long Term Anticoagulation Therapy) trial.

Methods: Of the 18,113 patients in the RE-LY study randomized to receive DE (110 mg or 150 mg twice daily) or warfarin, 16,490 patients with atrial fibrillation had creatinine values measured at baseline and at least 1 follow-up visit. Changes in GFR for up to 30 months were evaluated.

Results: GFR declined in all treatment groups. After an average of 30 months, the mean ± SE decline in GFR was significantly greater with warfarin (-3.68 ± 0.24 ml/min) compared with DE 110 mg (-2.57 ± 0.24 ml/min; p = 0.0009 vs. warfarin) and DE 150 mg (-2.46 ± 0.23 ml/min; p = 0.0002 vs. warfarin). A decrease in GFR >25% was less likely with DE 110 mg (hazard ratio: 0.81 [95% confidence interval: 0.69 to 0.96]; p = 0.017) or DE 150 mg (hazard ratio: 0.79 [95% confidence interval: 0.68 to 0.93]; p = 0.0056) than with warfarin in the observation period >18 months. Patients with poor international normalized ratio control (i.e., time in therapeutic range <65%) exhibited a faster decline in GFR. A more pronounced decline in GFR was associated with previous warfarin use and with the presence of diabetes.

Conclusions: Patients with atrial fibrillation receiving oral anticoagulation exhibited a decline in renal function that was greater in those taking warfarin versus DE, and it was amplified by diabetes and previous vitamin K antagonist use. (Randomized Evaluation of Long Term Anticoagulant Therapy [RE-LY] With Dabigatran Etexilate; NCT00262600).

Keywords: anticoagulation; atrial fibrillation; renal function; thrombin inhibition; vitamin K antagonist.

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Comment in

  • Atrial Fibrillation and Renal Function: How High Is the Price of Anticoagulation?
    Asinger RW, Shroff GR. Asinger RW, et al. J Am Coll Cardiol. 2015 Jun 16;65(23):2494-5. doi: 10.1016/j.jacc.2015.04.043. J Am Coll Cardiol. 2015. PMID: 26065987 No abstract available.
  • Anticoagulant-Related Nephropathy.
    Yang Y, Li G, Liu T. Yang Y, et al. J Am Coll Cardiol. 2015 Dec 15;66(23):2681-2682. doi: 10.1016/j.jacc.2015.08.1129. J Am Coll Cardiol. 2015. PMID: 26670071 No abstract available.
  • Reply: Anticoagulant-Related Nephropathy.
    Böhm M, Ezekowitz MD, Connolly SJ, Eikelboom JW, Hohnloser SH, Reilly PA, Schumacher H, Brueckmann M, Schirmer SH, Kratz MT, Yusuf S, Diener HC, Hijazi Z, Wallentin L. Böhm M, et al. J Am Coll Cardiol. 2015 Dec 15;66(23):2682. doi: 10.1016/j.jacc.2015.09.080. J Am Coll Cardiol. 2015. PMID: 26670072 No abstract available.

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