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Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial.

Publication ,  Journal Article
Flaker, G; Lopes, RD; Hylek, E; Wojdyla, DM; Thomas, L; Al-Khatib, SM; Sullivan, RM; Hohnloser, SH; Garcia, D; Hanna, M; Amerena, J; Dorian, P ...
Published in: J Am Coll Cardiol
October 14, 2014

BACKGROUND: Amiodarone is an effective medication in preventing atrial fibrillation (AF), but it interferes with the metabolism of warfarin. OBJECTIVES: This study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial. METHODS: Baseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone. The interaction between randomized treatment and amiodarone was tested using a Cox model, with main effects for randomized treatment and amiodarone and their interaction. Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization. RESULTS: In ARISTOTLE, 2,051 (11.4%) patients received amiodarone at randomization. Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone (56.5% vs. 63.0%; p < 0.0001). More amiodarone-treated patients had a stroke or a systemic embolism (1.58%/year vs. 1.19%/year; adjusted hazard ratio [HR]: 1.47, 95% confidence interval [CI]: 1.03 to 2.10; p = 0.0322). Overall mortality and major bleeding rates were elevated, but were not significantly different in amiodarone-treated patients and patients not on amiodarone. When comparing apixaban with warfarin, patients who received amiodarone had a stroke or a systemic embolism rate of 1.24%/year versus 1.85%/year (HR: 0.68, 95% CI: 0.40 to 1.15), death of 4.15%/year versus 5.65%/year (HR: 0.74, 95% CI: 0.55 to 0.98), and major bleeding of 1.86%/year versus 3.06%/year (HR: 0.61, 95% CI: 0.39 to 0.96). In patients who did not receive amiodarone, the stroke or systemic embolism rate was 1.29%/year versus 1.57%/year (HR: 0.82, 95% CI: 0.68 to 1.00), death was 3.43%/year versus 3.68%/year (HR: 0.93, 95% CI: 0.83 to 1.05), and major bleeding was 2.18%/year versus 3.03%/year (HR: 0.72, 95% CI: 0.62 to 0.84). The interaction p values for amiodarone use by apixaban treatment effects were not significant. CONCLUSIONS: Amiodarone use was associated with significantly increased stroke and systemic embolism risk and a lower time in the therapeutic range when used with warfarin. Apixaban consistently reduced the rate of stroke and systemic embolism, death, and major bleeding compared with warfarin in amiodarone-treated patients and patients who were not on amiodarone.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

October 14, 2014

Volume

64

Issue

15

Start / End Page

1541 / 1550

Location

United States

Related Subject Headings

  • Warfarin
  • United States
  • Treatment Outcome
  • Thromboembolism
  • Survival Rate
  • Stroke
  • Pyridones
  • Pyrazoles
  • Ontario
  • Middle Aged
 

Citation

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Flaker, G., Lopes, R. D., Hylek, E., Wojdyla, D. M., Thomas, L., Al-Khatib, S. M., … ARISTOTLE Committees and Investigators, . (2014). Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial. J Am Coll Cardiol, 64(15), 1541–1550. https://doi.org/10.1016/j.jacc.2014.07.967
Flaker, Greg, Renato D. Lopes, Elaine Hylek, Daniel M. Wojdyla, Laine Thomas, Sana M. Al-Khatib, Renee M. Sullivan, et al. “Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial.J Am Coll Cardiol 64, no. 15 (October 14, 2014): 1541–50. https://doi.org/10.1016/j.jacc.2014.07.967.
Flaker G, Lopes RD, Hylek E, Wojdyla DM, Thomas L, Al-Khatib SM, et al. Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1541–50.
Flaker, Greg, et al. “Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial.J Am Coll Cardiol, vol. 64, no. 15, Oct. 2014, pp. 1541–50. Pubmed, doi:10.1016/j.jacc.2014.07.967.
Flaker G, Lopes RD, Hylek E, Wojdyla DM, Thomas L, Al-Khatib SM, Sullivan RM, Hohnloser SH, Garcia D, Hanna M, Amerena J, Harjola V-P, Dorian P, Avezum A, Keltai M, Wallentin L, Granger CB, ARISTOTLE Committees and Investigators. Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1541–1550.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

October 14, 2014

Volume

64

Issue

15

Start / End Page

1541 / 1550

Location

United States

Related Subject Headings

  • Warfarin
  • United States
  • Treatment Outcome
  • Thromboembolism
  • Survival Rate
  • Stroke
  • Pyridones
  • Pyrazoles
  • Ontario
  • Middle Aged