Oral Anticoagulant Therapy in Atrial Fibrillation Patients at High Stroke and Bleeding Risk

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.

Download Full-text

Oral anticoagulant therapy in atrial fibrillation older patients with previous bleeding

Monaldi Archives for Chest Disease ◽

10.4081/monaldi.2020.1252 ◽

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.

Download Full-text

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

Blood ◽

10.1182/blood.v118.21.2311.2311 ◽

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.

Download Full-text