Major bleeding risk and healthcare economic outcomes of non-valvular atrial fibrillation patients newly-initiated with oral anticoagulant therapy in the real-world setting

2017 ◽  
Vol 20 (9) ◽  
pp. 952-961 ◽  
Author(s):  
Jay Lin ◽  
Jeffrey Trocio ◽  
Kiran Gupta ◽  
Jack Mardekian ◽  
Melissa Lingohr-Smith ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Real World ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Bleeding Risk ◽  
Economic Outcomes ◽  
The Real ◽  
Real World Setting

Clinical Performance of Bleeding Risk Scores for Predicting Major and Clinically Relevant Non-Major Bleeding Events in Patients Receiving Oral Anticoagulant Therapy

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2311-2311
Author(s):  
Sarag Burgess ◽  
Natalie Crown ◽  
Martha L Louzada ◽  
George Dresser ◽  
Richard Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Predictive Ability ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Risk Category ◽  
Thrombotic Complications

Abstract Abstract 2311 Oral anticoagulant therapy (OAT) is effective in preventing thrombotic complications in atrial fibrillation (AF) and venous thrombosis but its use is associated with increased bleeding. Risk scores such as CHADS2 are used to predict thrombotic complications in patients with AF, but scores predicting bleeding are less studied. A number of bleeding risk scores (BRS) has been proposed, however they might have different predictive abilities and performance. Moreover, these scores aim to identify major bleeding (MB) but have not evaluated clinically relevant non-major bleeding (CRNMB). Recent guidelines advocate the use of scores to assess bleeding risk in patients with atrial fibrillation being considered for OAT despite studies suggesting their limited utility. The purpose of this study was to evaluate the performance of 4 validated BRS for predicting MB and CRNMB. We conducted a retrospective, cohort study of consecutive patients enrolled in an academic OAT clinic between September 2008 and February 2011. Information regarding bleeding risk factors was collected for 4 BRS: Outpatient Bleeding Risk Index (OBRI; Beyth et al., Am J Med 1998), Contemporary Bleeding Risk Model (CBRM; Shireman et al., Chest 2006), HEMORR2HAGES (Gage et al. Am Heart J 2006), and HAS-BLED (Pisters et al., Chest 2010). Main outcomes were MB (Schulman J Thromb Haemost 2005) and a composite of MB + CRNMB (defined as overt bleeding that does not meet the criteria for MB but is associated with medical intervention, unscheduled contact, cessation of treatment, or associated with other discomfort (e.g. pain, impairment of daily activities). Incidence rates (IR) were calculated for each BRS and risk category. Correlation of bleeding risk categories among different BRS was assessed using the Kendall's tau-b coefficient. Predictive ability of each tool was evaluated using the C-statistic. Groups were compared using Fisher's exact, χ2, Mann-Whitney U, or Student's T tests. Hazard ratios (HR) for each score and risk category were estimated using Cox regression. We included 321 consecutive patients with a total follow-up of 319.2 patient-years. Mean age (SD) was 69.2 (13.6) years, 57% were males and 72.6% had AF. Overall IR for MB and MB + CRNMB were 3.7, and 11.2 events/100 patient-years, respectively. IRs for MB and MB + CRNMB separated by BRS and risk category are shown in Table 1 together with % of patients within each category. Overall, agreement among the 4 BRS was low to moderate with Kendall's tau-b coefficients ranging from 0.295 (OBRI vs CBRM) to 0.537 (HEMORR2HAGES vs HAS-BLED). C-statistics (95%CI) for predicting MB were 0.606 (0.435–0.777), 0.714 (0.548–0.879), 0.735 (0.583–0.886), and 0.672 (0.523–0.820), whereas those for predicting MB + CRNMB were 0.549 (0.452–0.645), 0.591 (0.489–0.692), 0.613 (0.517–0.709), and 0.587 (0.487–0.686) for OBRI, CBRM, HEMORR2HAGES and HAS-BLED, respectively. HRs for MB and MB + CRNMB are shown in Table 2. The best predictive ability for both MB and MB + CRNMB was for CBRM and HEMORR2HAGES. In conclusion, BRS classified bleeding risks differently. Predictive ability was moderate for MB and poor for MB + CRNMB. Overall, BRS are more helpful to identify patients at high bleeding risk, but they did not adequately identify patients at intermediate risk. Further studies assessing both MB and CRNMB are needed.Table 1.IR for bleeding eventsEvents/100 person-years (% patients in category)Score/OutcomeRisk CategoryMBLowIntermediateHigh    OBRI6.98 (16.2)2.63 (69.8)6.15 (14.0)    CBRM1.76 (70.1)6.62 (29.0)79.00 (0.9)    HEMORR2HAGES1.32 (48.9)3.71 (41.1)14.68 (10.0)    HAS-BLED0 (10.3)2.60 (60.1)7.38 (29.6)MB + CRNMB    OBRI9.3411.9714.68    CBRM9.6216.1279.00    HEMORR2HAGES8.2014.0620.94    HAS-BLED9.879.0718.91Table 2.HR for bleeding eventsMBMB+CRNBBleeding Risk ScoreHR95% CIpHR95% CIpOBRI    LowRefRef0.278RefRef0.798    Intermediate0.380.09–1.510.1691.290.45–3.690.636    High0.900.18–4.460.8951.520.44–5.220.503CBRM    LowRefRef<0.001RefRef0.007    Intermediate3.671.04–13.010.0441.790.92–3.480.085    High39.016.99–217.70<0.0018.712.02–37.520.004HEMORR2HAGES    LowRefRef0.008RefRef0.110    Intermediate2.770.54–14.280.2241.800.88–3.720.110    High10.942.12–56.420.0042.541.00–6.460.050HAS-BLED    LowRefRef0.212RefRef0.118    IntermediateNENE0.9490.970.28–3.290.959    HighNENE0.9431.910.56–6.520.302 Disclosures: Lazo-Langner: Pfizer Inc.: Honoraria; Leo Pharma: Honoraria.

P6559Long-term follow-up and outcomes of patients with discontinuation of oral anticoagulant therapy after successful ablation procedures for atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Fujino ◽  
H Yuzawa ◽  
T Kinoshita ◽  
M Shinohara ◽  
H Koike ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Low Risk ◽  
Risk Scores ◽  
Af Ablation ◽  
Successful Ablation

Abstract Background Oral anticoagulant therapy (OAT) is effective for preventing strokes in atrial fibrillation (AF) patients. Currently, there is controversy regarding the discontinuation of OATs in patients with ablation procedures to eliminate AF. Aim We investigated the incidence of major bleeding and ischemic strokes/systemic embolisms in low-risk patients that discontinued OATs after successful AF ablation procedures. Methods Of 330 consecutive patients that underwent AF ablation procedures and were prescribed one of the direct oral anticoagulants or warfarin, 207 AF patients (158 men, mean age 61±11 years) who discontinued OATs three months after the procedure were enrolled. The average CHADS2 and HAS-BLED scores were 1.0±0.9 and 1.2±1.0, respectively, which meant that most patients had a low risk for strokes. Results During follow-up, 31 patients (15%) had recurrences of AF. Those patients underwent a re-ablation procedure and then re-discontinued their OATs three months after the session. During a 60±13 months follow-up, major bleeding was observed in five patients (2.4%) and was associated with a higher HAS-BLED score (2.2±0.4 vs. 1.1±1.0, P=0.027). In contrast, none of the patients experienced ischemic strokes/systemic embolisms. Conclusions This prospective study demonstrated that in patients with successful ablation procedures and low risk scores for AF management, OATs could be discontinued three months after the procedure. Unnecessary continuation of OATs may increase the incidence of major bleeding during the follow-up.

scholarly journals Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation: A systematic review and meta-analysis

2018 ◽  
Vol 261 ◽  
pp. 84-91 ◽  
Author(s):  
Marco Proietti ◽  
Giulio Francesco Romiti ◽  
Imma Romanazzi ◽  
Alessio Farcomeni ◽  
Laila Staerk ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Meta Analysis

scholarly journals Differences in Perceived and Predicted Bleeding Risk in Older Adults With Atrial Fibrillation: The SAGE‐AF Study

2021 ◽  
Author(s):  
Benita A. Bamgbade ◽  
David D. McManus ◽  
Robert Helm ◽  
Jordy Mehawej ◽  
Jerry H. Gurwitz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Native American ◽  
Anticoagulant Therapy ◽  
Oral Anticoagulant ◽  
Risk Perceptions ◽  
Oral Anticoagulant Therapy ◽  
Bleeding Risk ◽  
Systematic Assessment ◽  
Patient Reported ◽  
History Of

Background Little research has evaluated patient bleeding risk perceptions in comparison with calculated bleeding risk among oral anticoagulant users with atrial fibrillation. Our objective was to investigate underestimation of bleeding risk and to describe the characteristics and patient‐reported outcomes associated with underestimation of bleeding risk. Methods and Results In the SAGE‐AF (Systematic Assessment of Geriatric Elements in Atrial Fibrillation) study, a prospective cohort study of patients ≥65 years with atrial fibrillation, a CHA 2 DS 2 ‐VASc risk score ≥2 and who were on oral anticoagulant therapy, we compared patients’ self‐reported bleeding risk with their predicted bleeding risk from their HAS‐BLED score. Among the 754 participants (mean age 74.8 years, 48.3% women), 68.0% underestimated their bleeding risk. Participants who were Asian or Pacific Islander, Black, Native American or Alaskan Native, Mixed Race or Hispanic (non‐White) (adjusted OR [AOR], 0.45; 95% CI, 0.24–0.82) and women (AOR, 0.62; 95% CI, 0.40–0.95) had significantly lower odds of underestimating their bleeding risk than respective comparison groups. Participants with a history of bleeding (AOR, 3.07; 95% CI, 1.73–5.44) and prior hypertension (AOR, 4.33; 95% CI, 2.43–7.72), stroke (AOR, 5.18; 95% CI, 1.87–14.40), or renal disease (AOR, 5.05; 95% CI, 2.98–8.57) had significantly higher odds of underestimating their bleeding risk. Conclusions We found that more than two‐thirds of patients with atrial fibrillation on oral anticoagulant therapy underestimated their bleeding risk and that participants with a history of bleeding and several comorbid conditions were more likely to underestimate their bleeding risk whereas non‐Whites and women were less likely to underestimate their bleeding risk. Clinicians should ensure that patients prescribed oral anticoagulant therapy have a thorough understanding of bleeding risk.

scholarly journals Oral anticoagulant therapy in atrial fibrillation older patients with previous bleeding

2020 ◽  
Vol 90 (1) ◽  
Author(s):  
Mario Bo ◽  
Francesco Giannecchini ◽  
Martina Papurello ◽  
Enrico Brunetti
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Antithrombotic Therapy ◽  
Oral Anticoagulant ◽  
Older Patients ◽  
Oral Anticoagulant Therapy ◽  
Unmet Need ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Risk Scores

Oral anticoagulant therapy (OAT) with direct oral anticoagulant (DOACs) is the established treatment to reduce thromboembolic risk in patients with atrial fibrillation (AF). Bleeding risk scores are useful to identify and correct factors associated with bleeding risk in AF patients on OAT. However, the clinical scenario is more complex in patients with previous bleeding event, and the decision about whether and when starting or re-starting OAT in these patients remains a contentious issue. Major bleeding is associated with a subsequent increase in both short- and long-term mortality, and even minimal bleeding may have prognostic importance because it frequently leads to disruption of antithrombotic therapy. There is an unmet need for guidance on how to manage antithrombotic therapy after bleeding has occurred. While waiting for observational and randomized data to accrue, this paper offers a perspective on managing antithrombotic therapy after bleeding in older patients with AF.

scholarly journals Importance of attributes and willingness to pay for oral anticoagulant therapy in patients with atrial fibrillation in China: A discrete choice experiment

PLoS Medicine ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. e1003730
Author(s):  
Jiaxi Zhao ◽  
Hao Wang ◽  
Xue Li ◽  
Yang Hu ◽  
Vincent K. C. Yan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Drug Interaction ◽  
Discrete Choice ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Choice Experiment ◽  
Oral Anticoagulant Therapy ◽  
Systemic Embolism ◽  
Lower Educational Attainment

Background Adherence to oral anticoagulant therapy in patients with atrial fibrillation (AF) in China is low. Patient preference, one of the main reasons for discontinuation of oral anticoagulant therapy, is an unfamiliar concept in China. Methods and findings A discrete choice experiment (DCE) was conducted to quantify patient preference on 7 attributes of oral anticoagulant therapy: antidote (yes/no), food–drug interaction (yes/no), frequency of blood monitoring (no need, every 6/3/1 month[s]), risk of nonfatal major bleeding (0.7/3.1/5.5/7.8[%]), risk of nonfatal stroke (ischemic/hemorrhagic) or systemic embolism (0.6/3.2/5.8/8.4[%]), risk of nonfatal acute myocardial infarction (AMI) (0.2/1.0/1.8/2.5[%]), and monthly out-of-pocket cost (0/120/240/360 RMB) (0 to 56 USD). A total of 16 scenarios were generated by using D-Efficient design and were randomly divided into 2 blocks. Eligible patients were recruited and interviewed from outpatient and inpatient settings of 2 public hospitals in Beijing and Shenzhen, respectively. Patients were presented with 8 scenarios and asked to select 1 of 3 options: 2 unlabeled hypothetical treatments and 1 opt-out option. Mixed logit regression model was used for estimating patients’ preferences of attributes of oral anticoagulants and willingness to pay (WTP) with adjustments for age, sex, education level, income level, city, self-evaluated health score, histories of cardiovascular disease/other vascular disease/any stroke/any bleeding, and use of anticoagulant/antiplatelet therapy. A total of 506 patients were recruited between May 2018 and December 2019 (mean age 70.3 years, 42.1% women). Patients were mainly concerned about the risks of AMI (β: −1.03; 95% CI: −1.31, −0.75; p < 0.001), stroke or systemic embolism (β: −0.81; 95% CI: −0.90, −0.73; p < 0.001), and major bleeding (β: −0.69; 95% CI: −0.78, −0.60; p < 0.001) and were willing to pay more, from up to 798 RMB to 536 RMB (124 to 83 USD) monthly. The least concerning attribute was frequency of blood monitoring (β: −0.31; 95% CI: −0.39, −0.24; p < 0.001). Patients had more concerns about food–drug interactions even exceeding preferences on the 3 risks, if they had a history of stroke or bleeding (β: −2.47; 95% CI: −3.92, −1.02; p < 0.001), recruited from Beijing (β: −1.82; 95% CI: −2.56, −1.07; p < 0.001), or men (β: −0.96; 95% CI: −1.36, −0.56; p < 0.001). Patients with lower educational attainment or lower income weighted all attributes lower, and their WTP for incremental efficacy and safety was minimal. Since the patients were recruited from 2 major hospitals from developed cities in China, further studies with better representative samples would be needed. Conclusions Patients with AF in China were mainly concerned about the safety and effectiveness of oral anticoagulant therapy. The preference weighting on food–drug interaction varied widely. Patients with lower educational attainment or income levels and less experience of bleeding or stroke had more reservations about paying for oral anticoagulant therapies with superior efficacy, safety, and convenience of use.

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