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Efficacy of prothrombin complex concentrate in the management of oral factor Xa inhibitors associated major bleed assessed by ISTH and ANNEXA-4 criteria

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Abstract

Direct oral anticoagulants (DOACs) are increasingly used for stroke prevention in atrial fibrillation and treatment and prevention of venous thromboembolism. They are also associated with bleeding risk. Existing literature suggests that prothrombin complex concentrate (PCC) administration may help control bleeding due to factor Xa inhibitors (FXaI). To determine the hemostatic efficacy of PCC in patients with major bleeding due to FXaI, we performed a retrospective chart review of 50 patients who presented with FXaI associated major bleeding that required urgent hemostatic management. Hemostatic assessment was performed using ISTH and ANNEXA-4 criteria. Twenty patients presented with intracranial hemorrhage (ICH), 20 had gastrointestinal bleeding, 3 had visceral bleeding, 3 had genitourinary bleeding, and 4 had miscellaneous types of bleeding. Fifty-six percent (28/50) had effective hemostasis using ISTH criteria and 84% (42/50) achieved effective hemostasis by ANNEXA-4 criteria. Hemostatic efficacy was similar by both tools for ICH (75% each). However, there was a major difference between ISTH and ANNEXA-4 hemostatic efficacy assessments for GI bleeding (45% and 95%, respectively). When comparing rivaroxaban and apixaban, there was no significant difference in effective hemostasis using either criteria, time to hemostasis, thromboembolic events, or patient mortality. Five (10%) patients had thromboembolic events within seven days of PCC administration, and the 30-day mortality rate was 14% (7/50). Our study shows similar efficacy, thromboembolic events, and mortality associated with PCC compared to andexanet alfa using ANNEXA-4 criteria, suggesting that PCC may be a viable alternative.

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Funding

This study did not receive any financial support.

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Authors and Affiliations

  1. Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA

    Pallavi Dev & Carol Abousaab

  2. UT Southwestern Medical School, UT Southwestern Medical Center, Dallas, TX, USA

    Cecilia Zhou

  3. Department of Pathology and Internal Medicine (Hematology/Oncology), UT Southwestern Medical Center, Dallas, TX, USA

    Ravi Sarode

Authors
  1. Pallavi Dev
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  2. Carol Abousaab
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  3. Cecilia Zhou
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  4. Ravi Sarode
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Contributions

All authors contributed to the study design. PD, CA, and CZ extracted and analyzed the data. All authors drafted the manuscript, revised it critically, and approved its final version.

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Correspondence to Pallavi Dev.

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Conflict of interest

Ravi Sarode is a consultant for Octapharma. None of the other authors have any conflict of interest.

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This is an observational study. The UT Southwestern Research Ethics Committee has confirmed that no ethical approval is required.

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Informed consent for participation was waived by the UT Southwestern and Parkland IRB for this anonymized, retrospective analysis of electronic medical record data.

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Informed consent for publication was waived by the UT Southwestern and Parkland IRB for this anonymized, retrospective analysis of electronic medical record data.

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Dev, P., Abousaab, C., Zhou, C. et al. Efficacy of prothrombin complex concentrate in the management of oral factor Xa inhibitors associated major bleed assessed by ISTH and ANNEXA-4 criteria. J Thromb Thrombolysis 53, 249–256 (2022). https://doi.org/10.1007/s11239-021-02536-x

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  • DOI: https://doi.org/10.1007/s11239-021-02536-x

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