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Patients with perceived high-bleeding risk and computerized decision support for stroke prevention in atrial fibrillation: an AF-ALERT substudy

Piazza: outcomes of high-bleeding risk AF patients

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Abstract

A perceived increased risk of bleeding is one of the most frequent reasons for withholding anticoagulation for stroke prevention in atrial fibrillation (AF). We previously conducted a randomized controlled trial of alert-based computerized decision support to increase prescription of anticoagulation in hospitalized patients with AF. To determine the clinical characteristics and outcomes of those patients whose inpatient health care providers received a computer alert, we analyzed all 248 patients in the alert group. Patients for whom providers elected to omit anticoagulation and provided a rationale of a perceived high risk of bleeding were compared with those who were not designated as high-risk. Perceived high risk of bleeding was the most common reason (77%) for omitting anticoagulation. Median HAS-BLED scores were similar in these patients compared with those who were not deemed to have an increased bleeding risk (3 vs. 3, p = 0.44). Despite being categorized as too high-risk for bleeding to receive antithrombotic therapy at the time of the alert, nearly 12% of these patients were ultimately prescribed anticoagulation by 90 days. The frequency of major and clinically-relevant non-major bleeding was similar between the groups. The frequency of death, myocardial infarction, stroke, or systemic embolic event was similar in both groups (10.2% vs. 12.4%, p = 0.59). In conclusion, a perceived high risk of bleeding was the most common reason for omission of anticoagulation in patients with AF after a computerized alert. Perceived high risk of bleeding was not reflected in a higher HAS-BLED score.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT02339493 https://clinicaltrials.gov/ct2/show/NCT02339493

Graphic Abstract

In a randomized controlled trial of computerized decision support to increase prescription of antithrombotic therapy in hospitalized patients with atrial fibrillation (AF), a perceived high risk of bleeding was the most common reason (77%) for omitting antithrombotic therapy after an on-screen alert. Median HAS-BLED scores were similar in these patients compared with those who were not deemed to have an increased bleeding risk (3 vs. 3, p = 0.44). Despite being categorized as too high-risk for bleeding to receive antithrombotic therapy for stroke prevention at the time of the alert, nearly 12% of these patients were ultimately prescribed anticoagulation over the ensuing 90 days.

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Data availability

The authors agree to provide the study data upon request.

Code availability

The authors agree to provide the computerized decision support program language upon request.

Abbreviations

AF:

Atrial fibrillation

BPA:

Best practice advisory

BWH:

Brigham and Women’s Hospital

CDS:

Computerized decision support

DOAC:

Direct oral anticoagulant

EHR:

Electronic health record

ISTH:

International Society on Thrombosis and Haemostasis

LMWH:

Low-molecular weight heparin

MI:

Myocardial infarction

VTE:

Venous thromboembolism

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Acknowledgements

This work was supported, in part, by an unrestricted research grant from Daiichi Sankyo.

Funding

This investigator-initiated study was funded, in part, by an unrestricted research Grant from Daiichi Sankyo.

Author information

Authors and Affiliations

  1. Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Gregory Piazza & Samuel Z. Goldhaber

  2. Division of Infectious Diseases, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Shelley Hurwitz

  3. Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

    Brett Carroll

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  1. Gregory Piazza
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  2. Shelley Hurwitz
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  3. Brett Carroll
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  4. Samuel Z. Goldhaber
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Contributions

All authors have conceived/designed the study and/or analyzed/interpreted the data, drafted or revised the manuscript for intellectual content, and approved the final submitted manuscript.

Corresponding author

Correspondence to Gregory Piazza.

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Conflict of interest

Dr. Piazza has received research support from Bristol-Myers Squibb, Bayer, Janssen, Portola, and BTG and consulting fees from Pfizer, Bayer, Janssen, Agile, Amgen and Portola. Dr. Goldhaber has received research support from Boehringer Ingelheim, Bristol-Myers Squibb, EKOS, a BTG International Company, Johnson & Johnson, and Janssen and consulting fees from Boehringer Ingelheim, Bayer, and Agile. Drs. Hurwitz and Carroll have no conflicts of interest to disclose.

Ethical approval

The study was approved by the Institutional Review Board of Partners HealthCare System.

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The Institutional Review Board waived the requirement of informed consent.

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Piazza, G., Hurwitz, S., Carroll, B. et al. Patients with perceived high-bleeding risk and computerized decision support for stroke prevention in atrial fibrillation: an AF-ALERT substudy. J Thromb Thrombolysis 52, 281–290 (2021). https://doi.org/10.1007/s11239-020-02296-0

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