scholarly journals Economic burden of major bleeding events in commercially insured patients with von Willebrand disease based on claims data from the United States

2020 ◽  
pp. 1-11
Author(s):  
Mei Lu ◽  
Abiola Oladapo ◽  
Yanyu Wu ◽  
Sepehr Farahbakhshian ◽  
Bruce Ewenstein
Keyword(s):  
United States ◽  
Major Bleeding ◽  
Economic Burden ◽  
Claims Data ◽  
The United States ◽  
Von Willebrand Disease ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Insured Patients ◽  
Von Willebrand

scholarly journals Prevalence and Burden of Major Bleeding Events in Patients with Von Willebrand Disease Based on Claims Data from the USA

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2222-2222
Author(s):  
Mei Lu ◽  
Abiola Oladapo ◽  
Yanyu Wu ◽  
Sepehr Farahbakhshian ◽  
Bruce Ewenstein
Keyword(s):  
Major Bleeding ◽  
Economic Burden ◽  
Von Willebrand Disease ◽  
Red Blood Cell Transfusion ◽  
Bleeding Events ◽  
Real World Data ◽  
Employment Equity ◽  
Equity Ownership ◽  
Major Bleeding Events ◽  
Von Willebrand

Abstract Background: Von Willebrand disease (VWD) is the most common inherited bleeding disorder (clinically symptomatic prevalence rate ~1:10,000). Patients with VWD have impaired hemostasis due to a quantitative or qualitative deficit in von Willebrand Factor (VWF) that alters platelet adhesion and collagen binding and/or decreases FVIII concentrations. Most patients with VWD present with mild-to-moderate mucosal bleeding (epistaxis, menorrhagia), although life-threatening bleeding may also occur, especially in patients with VWD type 3 and some forms of VWD type 2. While bleeds associated with VWD have been well described in the literature, information on the burden associated with major bleeding events (MBE) is limited. Real-world data can be used to help understand the clinical and economic impact of these events. Aims: To estimate the prevalence, healthcare resource utilization (HCRU), and costs associated with MBE among patients with VWD. Methods: Patients with VWD with ≥1 year of continuous enrollment since the eligibility start date were identified from Truven databases (01/2008-12/2016). Patients with MBEs were identified using a medical claim associated with an ICD-9/10 CM diagnosis code for intracranial, GI, or eye bleed; or menorrhagia, epistaxis, and joint bleeds that required red blood cell transfusion in an inpatient (IP) setting or within 7 days of diagnosis in an outpatient (OP) setting. Prevalence was calculated as the proportion of eligible patients with ≥1 MBE during the observation period (from start to the end of continuous eligibility). To evaluate economic burden, patients with ≥1 MBE on or after the first diagnosis of VWD were compared with patients with no MBEs. HCRU and cost in the 12-month continuous enrollment period following the first MBE were compared with those from a similar 12-month period for patients without MBEs. Regression models were used, controlling for demographics, health plan, index year, Charlson Comorbidity Index (CCI), comorbidities, thrombotic events, and HCRU during the 12-month continuously enrolled baseline period. For patients with MBEs, the proportion of patients with comorbidities was compared between the 12-month baseline and study periods using McNemar test. Results: 19,785 VWD patients were identified (mean age 34 years, 75% female) During a median observation of 4 years, 15.1% of patients experienced ≥1 MBE (mean rate: 0.11 ± 0.64 MBE/year). GI bleeding was the most prevalent MBE, occurring in 13.4% of all patients. Although not common, the prevalence of intracranial bleeds (1.1%) was slightly higher in males than females (1.7% vs 0.9%). In the sample to evaluate economic burden, 773 patients with ≥1 MBE (age 44.5 ± 20.1 years) and 4285 patients without MBEs (age 34.2 ± 19.5 years) were selected. Patients with MBEs were significantly (p<0.01) more likely to have an IP admission (OR, 4.1; 95% CI, 3.4-5.0), ER visit (1.8; 1.5-2.1), or OP visit (4.9; 1.8-13.4); they also had significantly longer IP stays (IRR, 3.9; 95% CI, 3.1-4.9) and more frequent IP admissions (3.2; 2.8-3.8), ER visits (2.0; 1.8-2.3), and OP visits (1.3; 1.2-1.3), compared to those without MBEs. Patients with MBEs incurred significantly (p<0.01) higher total healthcare costs (adjusted mean difference, $20,890; 95% CI, $15,524-$29,254) than those without MBEs. Among the 773 patients with MBEs, approximately 1 in 4 patients had a MBE (26.8%) diagnosed in the IP setting. The overall annual mean (± SD) IP length of stay (LOS) was 7.4 ± 19.4 days, with intracranial bleeds associated with the longest mean IP LOS (14.3 ± 19.4 days). The readmission rate was 3.1% for any MBE, and 2.5% for the same type of MBE as the initial bleed. The proportions of patients with anemia (24.2% vs 15.9%; p<0.01) and anxiety (18.6% vs 14.2%; p<0.01) were significantly higher after the MBE than before. Conclusions: In this large retrospective analysis of data from a US commercial healthcare plan, ~15% of patients with VWD experienced MBEs, mostly GI bleeds. While our estimation of some MBEs may be conservative, this is the first study to use a large dataset with sound statistical methods to evaluate the burden associated with MBEs in this population. MBEs were associated with additional comorbidities and high HCRU and costs (driven by inpatient costs), so optimal therapy is essential to prevent MBEs in patients with VWD. Disclosures Lu: Shire: Employment, Equity Ownership. Oladapo:Shire: Employment, Equity Ownership. Wu:Shire: Employment. Farahbakhshian:Shire: Employment, Equity Ownership. Ewenstein:Shire: Employment, Equity Ownership.

Abstract 16043: Effectiveness and Safety of Switching From Warfarin to Apixaban in Advanced Chronic Kidney Disease Patients With Prevalent Atrial Fibrillation in the United States Between 2012 and 2016

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Katherine Garlo ◽  
Thomas Mavrakanas ◽  
Elisabeth Burdick ◽  
Wei Wang ◽  
David Charytan
Keyword(s):  
United States ◽  
Major Bleeding ◽  
The United States ◽  
Bleeding Events ◽  
Part D ◽  
Safety Outcome ◽  
Efficacy Outcome ◽  
Major Bleeding Events ◽  
Ischemic Attack ◽  
Direct Acting

Introduction: Apixaban is the preferred direct acting oral anticoagulant in patients with CKD and has advantages compared with warfarin. Data on effectiveness and safety outcomes after switching from warfarin to apixaban in patients with prevalent AF and CKD are limited. Methods: Individuals with advanced CKD not on dialysis and prevalent AF who receive ≥6 months of continuous warfarin prior to Jan 1, 2012 were identified from the United States Data Renal System (USRDS) database. Individuals were followed from Jan 1, 2012 - Dec 31, 2015 to identify switches from warfarin to apixaban. The primary efficacy outcome was combined all-cause stroke, transient ischemic attack, or systemic thromboembolism. The primary safety outcome was major bleeding. Outcomes were compared between patients switching from apixaban and those continuing warfarin. Individuals were censored at the time of the first event or anticoagulation discontinuation, discontinuous Medicare part D coverage, dialysis, kidney transplant, a 2 nd switch in anti-coagulant, or death. Results: 1762 individuals with advanced CKD not receiving dialysis with non valvular AF or flutter were on warfarin during the 6 months prior to Jan 1, 2012. Of these, 71 (4.0%; 57.8% male, mean age 78.2 years (SD ±6.6), 78.9% white) switched from warfarin to apixaban and 1691 (41.3%; 47.6% male, mean age 80.1 years (SD ±8.7), 87.9% white) continued warfarin from Jan 1, 2012 - Dec 31, 2015. Incidence of all cause stroke or systemic thromboembolism in the apixaban switch and warfarin continuation groups were 1 (1.4%) and 303 (17.8%) respectively. Incidence of major bleeding events in the two groups were 1 (1.4%) and 201 (11.9%). Conclusions: Among advanced CKD patients with AF in the US who switched from warfarin to apixaban the proportion of all cause stroke or systemic thromboembolism and major bleeding events were low. Data is limited by duration of apixaban market authorization and short follow up.

scholarly journals Von Willebrand disease in the United States: perspective from the Zimmerman program

2018 ◽  
Vol 3 ◽  
pp. 7-7 ◽  
Author(s):  
Veronica H. Flood ◽  
◽  
Thomas C. Abshire ◽  
Pamela A. Christopherson ◽  
Kenneth D. Friedman ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Von Willebrand Disease ◽  
Von Willebrand

scholarly journals Anticoagulation Use and Outcomes Among Patients with Atrial Fibrillation and Von Willebrand Disease

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 590-590
Author(s):  
Lauren E. Merz ◽  
Duaa AbdelHameid ◽  
Dareen M. Kanaan ◽  
Guohai Zhou ◽  
Peter M. Manzo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Conflicts Of Interest ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Von Willebrand Disease ◽  
Fisher Exact Test ◽  
Bleeding Events ◽  
Coronary Syndrome ◽  
Von Willebrand

Abstract Intro: Von Willebrand disease (VWD) is a coagulopathy caused by deficiency or dysfunction of von Willebrand factor (VWF), resulting in prolonged and excessive bleeding. Patients are advised to avoid aspirin (ASA), P2Y12 inhibitors, or anticoagulation (AC) so as not to exacerbate this condition. However, typical treatment for atrial fibrillation (AF) includes anticoagulation, particularly if the risk of stroke by CHA 2DS 2-VASC score is 2+. Current recommendations suggest giving necessary antiplatelet (AP) or AC therapy over no treatment with assessment of bleeding risk throughout the course. However, this is a conditional recommendation based on low certainty in evidence, and there are no specific guidelines on treating AF in patients with VWD. This study aims to assess anticoagulation use, bleeding risk, and stroke risk in patients with VWF and AF. Methods: We conducted an IRB-approved analysis of coded data from institutional electronic medical records to select patients with diagnosis of VWD, low ristocetin cofactor level, or any abnormal VWF panel as well as patients with diagnosis of AF or atrial flutter. Three hundred and forty patients met criteria. Patients were manually screened for inclusion criteria and excluded for inaccurate diagnosis or insufficient data. Eighty-nine patients were included in the analysis. Primary endpoint was rate of major bleeding defined by ISTH criteria while on AC or AP. Categorical data were tested using the Fisher exact test at the nominal 0.05 two-sided significance level, and all person-time comparisons are made against the rate of bleeding on AC alone. Results: Most patients were female (64.0%; 57/89), and 28.1% (25/89) were deceased at the time of data collection. Date of diagnosis of AF ranged from 1980-2020. 42.7% (38/89) of patients were ever prescribed ASA, 43.8% (39/89) a P2Y12 inhibitor, 56.2% (50/89) AC, and 23.6% (21/89) had never been prescribed AP or AC. Of patients with a CHA 2DS 2-VASC of 2+, 57.5% (46/80) were ever prescribed AC. 32.0% (16/50) of patients ever prescribed AC and 25.6% (10/39) patients never prescribed AC had at least one major bleeding event (p=0.428). The rate of major bleeding on AC alone was 8.9 events per 100 person-years (32 events/359.2 years), 10.2 events per 100 person-years on AP alone (41 events/402.3 years) (p=0.572), and 1.06 events per 100 person-years (8 events/757.47 years) in patients never prescribed AC or AP (p=&lt;0.0001). Notably, the rate of major bleeding on AC and AP together was 28.07 events per 100 person-years (23 events/81.94 years) (p=&lt;0.0001) occurring in 7 patients, 6 of whom also had a diagnosis of acute coronary syndrome (ACS). Length of time to first major bleed is shown in Figure 1. 16.9% (15/89) of patients had thromboembolic strokes after diagnosis of AF, and 53.3% (8/15) of those strokes occurred when patients were not prescribed AC. Discussion: This retrospective observational study over 40 years characterizes AC and AP use in patients with VWD and AF. Only 57.5% of patients with CHA 2DS 2-VASC of 2+ received standard of care AC despite conditional recommendations to give necessary anticoagulation to patients with VWD. In parallel with the general population, AC use significantly increases the rate of major bleeding in patients with VWD, but there was no difference in bleeding rate between standard AC and AP monotherapy. However, major bleeding rates were notably elevated in patients prescribed concomitant AC and AP which most commonly occurred in the setting of ACS. This analysis is limited by its retrospective nature, the lack of granular details in the coded database, and incomplete data in older charts. Overall, these data do not support the use of AP monotherapy over standard AC to reduce bleeding rates for patients with VWD and AF. Additionally, AC and AP co-administration should be avoided due to high rates of major bleeding, but more studies are required to understand AP and AC strategies in patients with VWD, AF, and ACS. Although the rate of major bleeding is elevated with AC use in patients with VWD, there is no difference in lifetime prevalence of major bleeding events by AC vs no AC use. Finally, over half of thromboembolic strokes occurred when not prescribed AC. Shared decision-making around stroke and bleeding risk is advised in considering AC use for AF in patients with VWD. Prospective studies should further evaluate the risk of major bleeding and stroke in patients with VWD and AF on standard AC vs no AC. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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