Cardiology Practice

Amiodarone and Anticoagulant-Related Bleeding: Insights from a Medicare Cohort Study

Article Impact Level: HIGH
Data Quality: STRONG
Summary of Annals of Internal Medicine, M22-3238. https://doi.org/10.7326/M22-3238
Dr. Wayne Ray et al.

Points

  • This retrospective cohort study analyzed data from 91,590 Medicare beneficiaries aged 65 years or older with atrial fibrillation.
  • Amiodarone use during treatment with apixaban or rivaroxaban increased the risk of bleeding-related hospitalizations compared to flecainide or sotalol.
  • The incidence of ischemic stroke or systemic embolism did not significantly increase with amiodarone use.
  • Patients treated with amiodarone had a higher risk of death with recent bleeding evidence than other deaths.
  • Bleeding-related hospitalizations were more frequent in patients receiving rivaroxaban compared to apixaban.

Summary

This research paper presents a retrospective cohort study on U.S. Medicare beneficiaries aged 65 years or older with atrial fibrillation. The objective of the study was to compare the risk of bleeding-related hospitalizations in patients receiving the anticoagulant drugs apixaban or rivaroxaban while being treated with amiodarone, which inhibits the elimination of these anticoagulants, versus patients treated with flecainide or sotalol, which do not inhibit their elimination.

The study analyzed data from 91,590 patients (mean age, 76.3 years; 52.5% female) who initiated the use of the study anticoagulants and antiarrhythmic drugs, with 54,977 patients receiving amiodarone and 36,613 patients receiving flecainide or sotalol. The results demonstrated that the use of amiodarone increased the risk of bleeding-related hospitalizations compared to flecainide or sotalol, with a rate difference of 17.5 events (95% CI, 12.0 to 23.0 events) per 1000 person-years and a hazard ratio of 1.44 (CI, 1.27 to 1.63).

Moreover, the study assessed secondary outcomes such as ischemic stroke, systemic embolism, and death with or without recent evidence of bleeding. The incidence of ischemic stroke or systemic embolism did not significantly increase in patients treated with amiodarone compared to flecainide or sotalol, with a rate difference of −2.1 events (CI, −4.7 to 0.4 events) per 1000 person-years and a hazard ratio of 0.80 (CI, 0.62 to 1.03).

Additionally, the risk of death with recent evidence of bleeding was more significant in patients treated with amiodarone, with a rate difference of 9.1 events (CI, 5.8 to 12.3 events) per 1000 person-years and a hazard ratio of 1.66 (CI, 1.35 to 2.03), compared to other deaths (rate difference: 5.6 events [CI, 0.5 to 10.6 events] per 1000 person-years; hazard ratio: 1.15 [CI, 1.00 to 1.31]). Notably, the increased incidence of bleeding-related hospitalizations was higher in patients receiving rivaroxaban (rate difference: 28.0 events [CI, 18.4 to 37.6 events] per 1000 person-years) compared to those receiving apixaban (rate difference: 9.1 events [CI, 2.8 to 15.3 events] per 1000 person-years) (P = 0.001).

While the study provides valuable insights, it acknowledges the limitation of possible residual confounding. In conclusion, older patients with atrial fibrillation treated with amiodarone during apixaban or rivaroxaban use had a significantly higher risk of bleeding-related hospitalizations than those treated with flecainide or sotalol. These findings emphasize the importance of considering potential drug interactions and selecting appropriate antiarrhythmic drugs when prescribing anticoagulants to patients with atrial fibrillation.

Link to the article: https://www.acpjournals.org/doi/10.7326/M22-3238

References

Ray, W. A., Chung, C. P., Stein, C. M., Smalley, W., Zimmerman, E., Dupont, W. D., Hung, A. M., Daugherty, J. R., Dickson, A. L., & Murray, K. T. (2023). Risk for bleeding-related hospitalizations during use of amiodarone with apixaban or rivaroxaban in patients with atrial fibrillation: A retrospective cohort study. Annals of Internal Medicine, M22-3238. https://doi.org/10.7326/M22-3238

About the author

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