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Incidence and outcomes of patients with atrial fibrillation and major bleeding complications: from the TREAT-AF study

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Purpose

Optimal stroke prevention strategies for patients with atrial fibrillation (AF) who experience a major bleed are poorly defined. We sought to estimate the effectiveness and safety of oral anticoagulation (OAC) represcription after an OAC contraindication.

Methods

TREAT-AF is a retrospective cohort study of patients with newly diagnosed AF (2004–2012), treated in the Veterans Health Administration. From this cohort, we identified patients with a contraindication to OAC after AF diagnoses, defined as incident intracranial bleeding, non-intracranial bleeding requiring hospitalization, or unrepaired cerebral aneurysm or aortic dissection. We used multivariate Cox proportional hazards to estimate the association of OAC prescription in the 90 days following OAC contraindication to ischemic stroke and rebleeding.

Results

Among 167,190 patients with newly diagnosed AF (70 ± 11 years, 1.7% female, CHA2DS2-VASc 2.7 ± 1.7), 19,285 patients (11.5%) had an incident bleed (n = 18,342) or an unrepaired cerebral aneurysm or aortic dissection (n = 943). For OAC-contraindicated patients with a CHA2DS2-VASc ≥2 (N = 16,194), OAC was represcribed in 4075 patients (25%) and was associated with a higher risk of non-intracranial bleeding (HR 1.49; 95% CI 1.37–1.61; p < 0.0001) but no difference in intracranial bleeding. There was a trend toward decreased stroke risk (HR 0.85; 95% CI 0.71–1.02; p 0.09).

Conclusions

Development of contraindication to OAC after diagnosis of AF is common (11.5%), with most events requiring hospitalization. OAC reinitiation was associated with non-intracranial bleeding risk, with a trend toward reduced stroke risk. These data suggest that stroke prevention approaches after major bleeding events could be beneficial if bleeding risk can be successfully mitigated.

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Abbreviations

AF:

atrial fibrillation

DOAC:

direct oral anticoagulants

eGFR:

estimated glomerular filtration rate

GI:

gastrointestinal

OAC:

oral anticoagulation

TIA:

transient ischemic attack

VA:

Veteran Affairs

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Funding

Support for VA/CMS data is provided by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development, VA Information Resource Center (Project Numbers SDR 02–237 and 98–004). SentreHeart, Inc. (Redwood City, CA) sponsored the study.

Author information

Authors and Affiliations

  1. Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA

    Alexander C. Perino, Daniel W. Kaiser & Mintu P. Turakhia

  2. Veterans Affairs Palo Alto Health Care System, 3801 Miranda Ave - 111C, Palo Alto, CA, 94304, USA

    Alexander C. Perino, Jun Fan, Mariam Askari, Susan K. Schmitt & Mintu P. Turakhia

  3. Department of Medicine and Cardiovascular Research Institute, University of California San Francisco, San Francisco, CA, USA

    Randall J. Lee

  4. Center for Digital Health, Stanford University School of Medicine, Stanford, CA, USA

    Mintu P. Turakhia

Authors
  1. Alexander C. Perino
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  2. Daniel W. Kaiser
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  4. Jun Fan
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Corresponding author

Correspondence to Mintu P. Turakhia.

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Disclosures

A.C. Perino: Research support from the American Heart Association and Bristol-Myers Squibb/Pfizer. D.W. Kaiser: None. R.J. Lee: consultant to and equity holder for SentreHeart, Inc., Apama Medical (Boston Scientific, Inc), HMicro, Inc. J. Fan: None. M. Askari: None. S.S. Schmitt: None. M.P. Turakhia: Research Grant; Significant; Janssen Pharmaceuticals, Medtronic Inc., AstraZeneca, Veterans Health Administration, Cardiva Medical Inc. Other Research Support; Modest; AliveCor Inc., Amazon, Zipline Medical Inc., iBeat Inc., iRhythm Technologies Inc. Honoraria; Significant; Abbott. Honoraria; Modest; Medtronic Inc., Boehringer Ingelheim, Precision Health Economics, iBeat Inc., Akebia, Cardiva Medical Inc., Medscape/theheart.org.

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Perino, A.C., Kaiser, D.W., Lee, R.J. et al. Incidence and outcomes of patients with atrial fibrillation and major bleeding complications: from the TREAT-AF study. J Interv Card Electrophysiol 62, 133–142 (2021). https://doi.org/10.1007/s10840-020-00873-0

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  • DOI: https://doi.org/10.1007/s10840-020-00873-0

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