Availability of Specific Direct Oral Anticoagulant Reversal Agents in US Hospitals

Kanjee, Zahir; McCann, Marissa; Freed, Jason A.

doi:10.1001/jamanetworkopen.2021.10079

Cited by 15 publications

(4 citation statements)

References 7 publications

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“…34 While four-factor PCC has been commonly available in hospitals since its approval for VKA reversal in 2013, only 60% of the US hospitals providing emergency care have access to idarucizumab. 35 The availability of anticoagulant reversal agents in the event of major bleeding can potentially affect prescriber and patient preferences. 36 Additionally, concerns over the comprehensiveness of clinical trial data released for dabigatran and its safety profile may have further influenced All rights reserved.…”

Section: Discussionmentioning

confidence: 99%

Racial Disparities and Trends in Anticoagulant Use among Ambulatory Care Patients with Atrial Fibrillation and Atrial Flutter in the United States from 2007-2019

Kan,

Lapane,

McManus

et al. 2024

Preprint

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IntroductionAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia, significantly increasing the risk of stroke. The introduction of direct oral anticoagulants (DOACs) since 2010 has transformed anticoagulation therapy, offering an alternative to warfarin with improved safety profiles. Despite the increased adoption of DOACs, disparities in their use among different racial and ethnic groups in the United States remain understudied.MethodsThis study utilized a repeated cross-sectional design, analyzing data from the National Ambulatory Medical Care Survey (NAMCS) from 2007 to 2019. The study population included adults diagnosed with AF or atrial flutter (AFL). We analyzed the temporal trends of DOAC and warfarin use from 2007 to 2019. We examined the prevalence of DOAC versus warfarin use and assessed associations between race/ethnicity, patient characteristics, and DOAC utilization from 2011 to 2019. Multivariable modified Poisson regression models were used to calculate adjusted prevalence ratios (aPR) for the associations.ResultsFrom 2011 to 2019, NAMCS recorded 3,224 visits involving AF or AFL, representing a weighted estimate of 103.6 million visits. DOAC use increased significantly, with apixaban becoming the predominant anticoagulant by 2016. Non-Hispanic Black patients were less likely to use DOACs compared to non-Hispanic White patients over time (aPR 0.75; 95% CI, 0.63-0.90). Patients with Medicaid insurance were also less likely to use DOACs (aPR 0.14; 95% CI: 0.04-0.46).ConclusionDespite the shift from warfarin to DOACs for AF and AFL treatment, significant racial and socioeconomic disparities persist. Non-Hispanic Black patients and those with Medicaid insurance are less likely to use DOACs. These findings highlight the need for targeted strategies to ensure equitable access to advanced anticoagulant therapies.

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Section: Discussionmentioning

confidence: 99%

Racial Disparities and Trends in Anticoagulant Use among Ambulatory Care Patients with Atrial Fibrillation and Atrial Flutter in the United States from 2007-2019

Kan,

Lapane,

McManus

et al. 2024

Preprint

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“… 6 Andexanet alfa is not approved for use in all countries, can be costly, and the need for reconstitution from multiple vials could result in delays in administration. 36 37 In the absence of specific reversal therapy, nonspecific treatments, such as PCC, are often given, a practice that is supported by expert consensus guidance. 38 39 Phase II clinical trials evaluating the biochemical effect of reversal agents, such as andexanet alfa, have demonstrated complete reversal of the anticoagulant effects of FXaIs.…”

Section: Discussionmentioning

confidence: 99%

Effect of PCC on Thrombin Generation among Patients on Factor Xa Inhibitors with Major Bleeding or Needing Urgent Surgery (GAUGE): Design and Rationale

Shaw

Unachukwu

Cyr

et al. 2023

TH Open

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Background Direct factor Xa inhibitors (FXaIs) account for most oral anticoagulant use and FXaI-associated bleeding events are common. Clinicians have variable national and regional access to specific FXaI reversal agents such as andexanet alfa. Many centers have adopted the use of prothrombin complex concentrates (PCCs) as hemostatic therapy for FXaI-associated major bleeding events. PCC does not impact circulating FXaI levels and its mechanism of action to achieve hemostasis in FXaI-associated bleeding is uncertain. While PCC increases quantitative thrombin generation assay (TGA) parameters, it does not correct FXaI-altered thrombin generation kinetics, nor does it normalize thrombin generation. Clinical data supporting the use of PCC are based on cohort studies reporting clinical hemostatic efficacy, which is difficult to measure. The benefits of PCC for FXaI-associated bleeding beyond supportive care are uncertain. Objective GAUGE is a prospective observational study designed to measure the effects of four-factor PCC administration (Octaplex) on TGA parameters among patients with FXaI-associated bleeding or needing urgent surgery. Methods Laboratory outcomes will include the mean paired change in TGA parameters from pre- to post-PCC administration and the proportion of participants whose post-PCC TGA values fall within a defined reference range. Clinical outcomes will include hemostatic efficacy, thromboembolic complications, and all-cause death at 30 days post-PCC. Conclusion Development of a viable and universally accessible FXaI bleed management strategy is crucial. GAUGE will provide in vivo data on the effects of PCC among patients with FXaI-associated bleeding.

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“…70 71 Unlike idarucizumab, andexanet alfa is not yet approved in many countries, is only available in few hospitals in the United States (12% in the most recent Medicare survey), and is at least five times more expensive. 72 As an alternative to andexanet alfa, four factor prothrombin complex concentrate is often used to enhance hemostasis in patients taking an oral factor Xa inhibitor who have an indication for reversal. 73…”

Section: Loose Endsmentioning

confidence: 99%

Clinical Studies with Anticoagulants that Have Changed Clinical Practice

Hirsh

Vries

Eikelboom

et al. 2023

Semin Thromb Hemost

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Anticoagulant therapy is the cornerstone of treatment and prevention of arterial and venous thromboembolism. Taking a historical perspective, starting in the 1960s, and progressing through to 2022, we discuss key clinical trials of anticoagulants that have changed clinical practice, and examine obstacles encountered in bringing these anticoagulants to the clinic. The design of some of the early studies that shaped clinical practice was poor by current standards, but their results were influential because nothing better was available. Both heparin and vitamin K antagonists had been in clinical use for several decades before well-designed trials in the 1980s optimized their dosing and enhanced their safety and efficacy. Low-molecular-weight heparin then replaced unfractionated heparin because it had a more predictable dose–response and a longer half-life, thereby allowing it to be used conveniently in out-of-hospital settings. More recently, direct oral anticoagulants became the oral anticoagulants of choice for most indications because they were shown to be at least as safe and effective as vitamin K antagonists when used in fixed doses without the need for laboratory monitoring. The design of the trials that led to the approval of the direct oral anticoagulants was excellent, but further studies are required to optimize their dosing in selected patients who were underrepresented in these trials.

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Availability of Specific Direct Oral Anticoagulant Reversal Agents in US Hospitals

Cited by 15 publications

References 7 publications

Racial Disparities and Trends in Anticoagulant Use among Ambulatory Care Patients with Atrial Fibrillation and Atrial Flutter in the United States from 2007-2019

Racial Disparities and Trends in Anticoagulant Use among Ambulatory Care Patients with Atrial Fibrillation and Atrial Flutter in the United States from 2007-2019

Effect of PCC on Thrombin Generation among Patients on Factor Xa Inhibitors with Major Bleeding or Needing Urgent Surgery (GAUGE): Design and Rationale

Clinical Studies with Anticoagulants that Have Changed Clinical Practice

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