Therapeutic Strategies Following Major, Clinically Relevant Nonmajor, and Nuisance Bleeding in Atrial Fibrillation: Findings From ORBIT‐AF

O’Brien, Emily C.; Holmes, Da Juanicia N.; Thomas, Laine; Fonarow, Gregg C.; Kowey, Peter R.; Ansell, Jack; Mahaffey, Kenneth W.; Gersh, Bernard J.; Peterson, Eric D.; Piccini, Jonathan P.

doi:10.1161/jaha.117.006391

Cited by 13 publications

(8 citation statements)

References 19 publications

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“…Also, all bleeding events are associated with an impaired quality of life 28. Irrespective of type, patients experiencing a bleeding event are more likely to discontinue OAC treatment,29 which is associated with an increased risk for clinically significant events 30…”

Section: Discussionmentioning

confidence: 99%

Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS‐BLED and GARFIELD‐AF Bleeding Scores

Proietti

Rivera‐Caravaca

Esteve-Pastor

et al. 2018

JAHA

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BackgroundPatients with atrial fibrillation (AF) treated with oral anticoagulants may be exposed to an increased risk of bleeding events. The HAS‐BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INRs, Elderly, Drugs or alcohol) score is a simple, well‐established, clinical bleeding‐risk prediction score. Recently, a new algorithm‐based score was proposed, the GARFIELD‐AF (Global Anticoagulant in the Field–AF) bleeding score. We compared HAS‐BLED and GARFIELD‐AF scores in predicting adjudicated bleeding events in a clinical trial cohort of patients with AF taking anticoagulants, in the first external comparative validation of both scores.Methods and ResultsWe analyzed patients from the SPORTIF (Stroke Prevention Using an Oral Thrombin Inhibitor in Patients With AF) III and V trials. All patients assigned to the warfarin arm with information to calculate the scores were considered. Outcomes were major, major/clinically relevant nonmajor, and any bleeding. A total of 3550 warfarin‐treated patients were available for analysis. Of these patients, 2519 (71.0%) had a HAS‐BLED score ≥3, whereas based on GARFIELD‐AF median value, 2056 (57.9%) were categorized as “high score.” Both HAS‐BLED and GARFIELD‐AF C‐indexes showed modest predictive value (C‐index [95% confidence interval] for major bleeding, 0.58 [0.56–0.60] and 0.56 [0.54–0.57], respectively); however, GARFIELD‐AF was not predictive of any bleeding. The GARFIELD‐AF bleeding score had a significantly lower sensitivity and a negative reclassification for any bleeding compared with HAS‐BLED, assessed by integrated discrimination improvement and net reclassification improvement (both P<0.001). HAS‐BLED showed a 5% net benefit for any bleeding occurrence.ConclusionsThe algorithm‐based GARFIELD‐AF bleeding score did not show any significant improvement in major and major/clinically relevant nonmajor prediction compared with the simple HAS‐BLED score. For clinical usefulness in prediction of any bleeding, the HAS‐BLED score showed a significant net benefit compared with the GARFIELD‐AF.

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Section: Discussionmentioning

confidence: 99%

Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS‐BLED and GARFIELD‐AF Bleeding Scores

Proietti

Rivera‐Caravaca

Esteve-Pastor

et al. 2018

JAHA

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“…Our findings demonstrate heterogeneity in clinical outcomes across bleeding definitions and thus call for definition revision with anchoring to clinically relevant outcomes for both patient and care providers. Perhaps a graded measure, such as the modified Rankins scale used in stroke research, could provide a potential solution [32]. In a points-based outcome measure, criteria with stronger association with death or OAC cessation, such as intracranial hemorrhage, would be weighted more heavily (i.e.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of definitions for oral anticoagulant-associated major bleeding: A population-based cohort study

Gomes

Wells

et al. 2022

Thrombosis Research

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“…This study suggests that, despite similar hospitalization costs, the rate of outpatient hospital visits and corresponding costs (which may not differ significantly shortly after treatment initiation 27,30 ) can in the long-term drive the healthcare costs as observed in patients initiating apixaban compared to rivaroxaban. Outpatient hospital visits, which are more costly than office visits and are typically observed among patients with more severe disease 31,32 , may be driven by complications associated with AF that could be managed in an outpatient setting 33,34 , such as transient ischemic attacks and clinically-relevant non-major bleeding 35,36 . Together with the present results, this may indicate that patients using rivaroxaban achieve better disease control than those using apixaban, thus requiring fewer outpatient hospital visits to manage complications and subsequently incurring lower medical costs.…”

Section: Discussionmentioning

confidence: 99%

Healthcare costs of NVAF patients treated with rivaroxaban and apixaban in the US

Milentijevic

Germain

Laliberté

et al. 2020

Journal of Medical Economics

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Objectives: To provide the most current assessment of real-world healthcare resource utilization (HRU) and costs among patients with non-valvular atrial fibrillation (NVAF) who newly initiated rivaroxaban and apixaban using a large US database. Material and methods: A retrospective weighted cohort design was used with healthcare insurance claims from the Optum Clinformatics Data Mart databases (January 2012-December 2018). The index date was defined as the first dispensing of rivaroxaban or apixaban. Adult NVAF patients with an index date on or after 1 January 2016, ! 12 months of continuous eligibility before the index date and ! 1 month after, and without prior use of oral anticoagulant were included. The observation period spanned from the index date to the earliest of the end of data availability, end of insurance coverage, or death. Inverse probability of treatment weighting (IPTW) was used to adjust for differences in baseline characteristics between cohorts. All-cause healthcare resource utilization (HRU), including hospitalization, emergency room, and outpatient visits, and healthcare costs, including medical and pharmacy costs, were evaluated from the payer's perspective during the observation period up to 18 and 24 months, separately. Results: In total, 23,822 rivaroxaban and 53,666 apixaban users were included. After weighting, all baseline characteristics were well balanced between cohorts (mean age: 73.8 years, female: 46.6% in both cohorts). Up to 18 months of follow-up, rivaroxaban users incurred significantly lower total healthcare costs compared to apixaban users (cost difference ¼ À$1,121; p ¼ 0.020), driven by significantly lower rates of outpatient hospital visits and associated costs (cost difference ¼ À$1,579; p < 0.001). Similar results were found in the analysis conducted for up to 24 months of follow-up (total cost difference ¼ -$1,111; p ¼ 0.020). Conclusions: In this large retrospective analysis, patients with NVAF initiated on rivaroxaban incurred significantly lower healthcare costs compared to those initiated on apixaban, which were primarily driven by significantly lower outpatient visits and costs during the 18-and 24-month followup periods.

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Therapeutic Strategies Following Major, Clinically Relevant Nonmajor, and Nuisance Bleeding in Atrial Fibrillation: Findings From ORBIT‐AF

Cited by 13 publications

References 19 publications

Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS‐BLED and GARFIELD‐AF Bleeding Scores

Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS‐BLED and GARFIELD‐AF Bleeding Scores

Evaluation of definitions for oral anticoagulant-associated major bleeding: A population-based cohort study

Healthcare costs of NVAF patients treated with rivaroxaban and apixaban in the US

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