Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries

Williams, James M.; Lovelace, Belinda; Christoph, Mary J.; Li, Suying; Guo, Haifeng; Hoover, Madison; Coleman, Craig I

doi:10.1002/emp2.12956

Cited by 2 publications

(1 citation statement)

References 23 publications

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“…Patients with no additional non-sex risk factors for ischaemic stroke should not be prescribed an OAC, since the risk of bleeding outweighs the benefit [7]. Moreover, the use of OACs in low-risk patients might increase healthcare costs, associated with drug costs and the management of complications secondary to the therapy, particularly bleeding [20,21].…”

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confidence: 99%

Oral Anticoagulant Use in Patients with Atrial Fibrillation at Low Risk of Stroke and Associated Bleeding Complications

Kefale,

Bezabhe,

Peterson

2023

JCM

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Background: The use of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) and low stroke risk might cause more harm than benefit. Little attention has been given to address its prevalence and associated consequences. This study aimed to investigate the prescription rate of OACs, identify associated factors, and describe incident bleeding events in low-risk patients. Methods: We included patients with a new diagnosis of AF between 1 January 2011 and 31 December 2018 having a low risk of stroke (CHA2DS2-VASc score of 0 for males and 1 for females) from Australian general practice data (MedicineInsight). Patients were classified as OAC users if there was a recorded prescription of an OAC within 60 days of AF diagnosis, and factors associated with the prescription of an OAC were assessed using logistic regression. Recorded incident bleeding events were identified within 6 months after AF diagnosis or after OAC initiation for OAC non-users and users, respectively. The risk of bleeding was compared between the two groups by adjusting their baseline differences using propensity score matching. Results: The study included 2810 low-risk patients (62.3% male) with a mean age of 49.3 ± 10.8 years. Of the total, 705 (25.1%) patients had a record of OAC prescription within 60 days of diagnosis of AF. Older age (odds ratio [OR] 1.03; 95% confidence interval [CI] 1.03–1.04) and diagnosis periods (2015–2016 [OR 1.46; 95% CI 1.10–1.94] and 2017–2018 [OR 1.65; 95% CI 1.17–2.23] vs. 2011–2012) were associated with higher odds of OAC initiation. Female sex (OR 0.71; 95% CI 0.59–0.85), higher bleeding risk (ORBIT score; OR 0.80; 95% CI 0.68–0.94), and higher socioeconomic index for areas (SEIFA) quintiles (SEIFA quintiles; 2 [OR 0.65; 95% CI 0.48–0.88], 3 [OR 0.74; 95% CI 0.56–0.98], 4 [OR 0.70; 95% CI 0.52–0.94], 5 [OR 0.69; 95% CI 0.52–0.91] compared with quintile 1) were associated with lower odds of OAC prescription. A total of 52 (in 1.8% of patients) incident bleeds were identified, with 18 (2.6%) among OAC users. The rate of bleeding was not significantly different between users and non-users after matching. However, within OAC users, commencement of OAC was associated with an increased risk of bleeding compared to the period before OAC initiation (p = 0.006). Conclusions: One in four patients at low risk of stroke received an OAC within 60 days of AF diagnosis. Older age and the period following the widespread availability of direct-acting OACs were associated with an increased likelihood of OAC prescription. Positively, using OACs was not associated with an increased rate of bleeding compared to non-users.

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confidence: 99%

Oral Anticoagulant Use in Patients with Atrial Fibrillation at Low Risk of Stroke and Associated Bleeding Complications

Kefale,

Bezabhe,

Peterson

2023

JCM

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Andexanet alfa versus PCC products for factor Xa inhibitor bleeding: A systematic review with meta‐analysis

White,

Caroti,

Bessada

et al. 2024

Pharmacotherapy

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Previous meta‐analyses assessed andexanet alfa (AA) or prothrombin complex concentrate (PCC) products for the treatment of Factor Xa inhibitor (FXaI)‐associated major bleeding. However, they did not include recent studies or assess the impact of the risk of bias. We conducted a systematic review with meta‐analysis on the effectiveness of AA versus PCC products for FXaI‐associated major bleeding, inclusive of the studies' risk of bias. PubMed and Embase were searched for comparative studies assessing major bleeding in patients using FXaI who received AA or PCC. We used the Methodological Index for NOn‐Randomized Studies (MINORS) checklist and one question from the Joanna Briggs Institute (JBI) Critical Appraisal of Case Series tool to assess the risk of bias. Random‐effects meta‐analyses were performed to provide a pooled estimate for the effect of AA versus PCC products on hemostatic efficacy, in‐hospital mortality, 30‐day mortality, and thrombotic events. Low–moderate risk of bias studies were meta‐analyzed separately, as well as combined with high risk of bias studies. Eighteen comparative evaluations of AA versus PCC were identified. Twenty‐eight percent of the studies (n = 5) had low–moderate risk and 72% (n = 13) had a high risk of bias. Studies with low–moderate risk of bias suggested improvements in hemostatic efficacy [Odds Ratio (OR) 2.72 (95% Confidence Interval (CI): 1.15–6.44); one study], lower in‐hospital mortality [OR 0.48 (95% CI: 0.38–0.61); three studies], and reduced 30‐day mortality [OR 0.49 (95% CI: 0.30–0.80); two studies] when AA was used versus PCC products. When studies were included regardless of the risk of bias, pooled effects showed improvements in hemostatic efficacy [OR 1.36 (95% CI: 1.01–1.84); 12 studies] and reductions in 30‐day mortality [OR 0.53 (95% CI: 0.37–0.76); six studies] for AA versus PCC. The difference in thrombotic events with AA versus PCC was not statistically significant in the low–moderate, high, or combined risk of bias groups. The evidence from low–moderate quality real‐world studies suggests that AA is superior to PCC in enhancing hemostatic efficacy and reducing in‐hospital and 30‐day mortality. When studies are assessed regardless of the risk of bias, the pooled hemostatic efficacy and 30‐day mortality risk remain significantly better with AA versus PCC.

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Clinical and health care resource use burden of hospitalizations for oral factor Xa inhibitor‐associated major bleeding: A real‐world analysis of Medicare beneficiaries

Cited by 2 publications

References 23 publications

Oral Anticoagulant Use in Patients with Atrial Fibrillation at Low Risk of Stroke and Associated Bleeding Complications

Oral Anticoagulant Use in Patients with Atrial Fibrillation at Low Risk of Stroke and Associated Bleeding Complications

Andexanet alfa versus PCC products for factor Xa inhibitor bleeding: A systematic review with meta‐analysis

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