Assessing Bleeding Risk in Atrial Fibrillation Patients: Comparing a Bleeding Risk Score Based Only on Modifiable Bleeding Risk Factors against the HAS-BLED Score. The AMADEUS Trial

2017 ◽  
Vol 117 (12) ◽  
pp. 2261-2266 ◽  
Author(s):  
María Esteve-Pastor ◽  
José Rivera-Caravaca ◽  
Alena Shantsila ◽  
Vanessa Roldán ◽  
Gregory Lip ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Risk Score ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Clinical Score ◽  
International Normalized Ratio ◽  
Bleeding Events ◽  
Modifiable Factors

Background The HAS-BLED (hypertension, abnormal renal/liver function, previous stroke, bleeding history or predisposition, labile international normalized ratio [INR], elderly and drugs/alcohol consumption) score has been validated in several scenarios but the recent European guidelines does not recommend any clinical score to assess bleeding risk in atrial fibrillation (AF) patients and only focus on modifiable clinical factors. Purpose The aim of this study was to test the hypothesis that the HAS-BLED score would perform at least similarly to an approach only based on modifiable bleeding risk factors (i.e. a ‘modifiable bleeding risk factors score’) for predicting bleeding events. Methods We performed a comparison between the HAS-BLED score and the new ‘modifiable bleeding risk factors score’ in a post hoc analysis in 4,576 patients included in the AMADEUS trial. Results After 347 (interquartile range, 186–457) days of follow-up, 597 patients (13.0%) experienced any clinically relevant bleeding event and 113 (2.5%) had a major bleeding. Only the HAS-BLED score was significantly associated with the risk of any clinically relevant bleeding (Cox's analysis for HAS-BLED ≥ 3: hazard ratio 1.38; 95% confidence interval [CI], 1.10–1.72; p = 0.005). The ‘modifiable bleeding risk factors score’ ≥ 2 were non-significantly associated with any clinical relevant bleeding. The two scores had modest ability in predicting bleeding events. The HAS-BLED score performed best in predicting any clinically relevant bleeding (c-indexes for HAS-BLED, 0.545 [95% CI, 0.530–0.559] vs. the ‘modifiable bleeding risk factors score’, 0.530 [95% CI, 0.515–0.544]; c-index difference 0.015, z-score = 2.063, p = 0.04). The HAS-BLED score with one, two and three modifiable factors performed significantly better than the ‘modifiable bleeding risk factors scores’ with one, two and three modifiable risk factors. Conclusion When compared with an approach only based on modifiable bleeding risk factors proposed by European Society of Cardiology (ESC) AF guidelines, the HAS-BLED score performed significantly better in predicting any clinically relevant bleeding in this clinical trial cohort. While modifiable bleeding risk factors should be addressed in all AF patients, the use of a formal bleeding risk score (HAS-BLED) has better predictive value for bleeding risks, and would help decision-making in identifying ‘high risk’ patients for scheduling reviews and follow-up.

Abstract 12014: Modified HASBLED Bleeding Risk Score in Dialysis Patients With Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Michele Murphy ◽  
William Maddox ◽  
Stan Nahman ◽  
Matthew Diamond ◽  
Robert Sorrentino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Failure ◽  
Liver Function ◽  
Renal Disease ◽  
Risk Score ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Major Bleeding Events

Introduction: Hemodialysis patients (HD pts) with atrial fibrillation (AF) have increased risk of stroke. The HASBLED (Hypertension (HTN), Abnl Renal/Liver Function, Stroke, Bleeding Hx, Labile INR, Elderly, Drugs/Alcohol) risk score predicts bleeding in the general AF population. It is unknown whether the HASBLED score can be applied to HD pts who are at additional bleeding risk due to uremic platelet dysfunction and the regular use of heparin. Hypothesis: To address this question, we queried the United States Renal Data System (USRDS) for bleeding events in HD pts with AF, and correlated those events with a modified HASBLED (mHASBLED) score. Methods: All incident HD pts with AF from the USRDS for 2006-2010 were queried for major bleeding events and mHASBLED parameters using ICD-9 diagnosis codes and data from CMS form 2728. For mHASBLED, the HTN parameter was defined as "HTN as the cause of renal failure", and labile INR as > 16 INRs/yr, but all other parameters could be derived from the dataset. Logistic regression (LR) analysis was used to estimate the odds ratio (OR) for the mHASBLED score to predict major bleeding events. Results: 74,631 HD pts had AF, and 9.8% had a major bleeding event (GI bleeding and hemorrhagic stroke). By univariate analysis, those who bled were more likely to be elderly, have an underlying cause of renal disease due to HTN, prior bleeding event, hepatitis C, labile INR, and be on oral anticoagulants. By LR, variables with the greatest impact on bleeding were HTN as a cause of underlying renal disease, prior bleeding history, and labile INR (OR of 1.10, 2.20 and 2.24, respectively). The OR for bleeding events increased by 1.28 for each unit increase in mHASBLED. Older age, prior stroke, abnormal renal or liver function, and drug use had the least effect. Note that the lowest possible score in this cohort is 1, given that all patients had renal failure. Conclusions: In HD pts with AF, the mHASBLED predicts major bleeding events. The universal presence of renal disease, and the lack of specific clinical data from the USRDS may limit the clinical precision of a given score, however mHASBLED may remain a useful indicator of bleeding risk in this population.

Abstract 17598: More Than One in Five Older Veterans are Hospitalized for Bleeding Following Initiation of Warfarin for Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
John A Dodson ◽  
Andrew Petrone ◽  
David Gagnon ◽  
Mary E Tinetti ◽  
Harlan M Krumholz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Time Period ◽  
Increased Risk ◽  
Anticoagulation Clinics ◽  
Comorbidity Burden

Introduction: Clinicians are hesitant to prescribe oral anticoagulants to older adults with atrial fibrillation (AF) due to concerns over bleeding risk. Hypothesis: As many data on bleeding events are from trials of rigorously selected patients, we hypothesized that major bleeding events (requiring hospitalization) would be more common than previously reported. Methods: We created a retrospective cohort of 31,951 Veterans with AF aged ≥75 years who were new referrals to VA anticoagulation clinics (warfarin) from 1/1/02 - 12/31/12. Patients with comorbid conditions requiring warfarin (e.g. pulmonary embolus) were excluded. Data were extracted from the VA electronic medical record and linked with Medicare claims data for subsequent hospitalizations. The primary outcome was any hospitalization for bleeding. We identified bleeding subtypes by source, and compared characteristics of patients with and without bleeding hospitalizations. Results: Mean population age was 81.1 years, 98.1% were male, and 8.4% were nonwhite. Over a median follow-up period of 2.62 years, 7288 patients (22.8%) were hospitalized for bleeding. There were 12,004 total bleeding events; overall, 980 (13.4%) patients experienced multiple events. The most common bleeding sources (first event) were gastrointestinal (50.8%), genitourinary (21.6%), and intracranial (9.4%) (Figure). The median time to first bleeding event was 1.59 years. Patients hospitalized for bleeding were more likely to have coronary disease (48.4% vs. 40.9%, P<0.01); COPD (28.4% vs. 24.7%, P<0.01); chronic kidney disease (17.8% vs. 16.0%, P<0.01); CHF (34.7% vs. 29.5%, P<0.01), and labile INR (63.3% vs. 53.7%, P<0.01). The rate of hospitalization for stroke over the same time period was 5.0%. Conclusions: After initiating warfarin, over one in five older Veterans are hospitalized for bleeding, most commonly from a gastrointestinal source. Comorbidity burden and labile INR place these patients at increased risk.

scholarly journals Characterization of Atrial Fibrillation and Bleeding Risk Factors in Patients with Chronic Lymphocytic Leukemia (CLL): A Population-Based Retrospective Cohort Study of Administrative Medical Claims Data in the United States (US)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3301-3301 ◽  
Author(s):  
Jacqueline C. Barrientos ◽  
Nicole Meyer ◽  
Xue Song ◽  
Kanti R Rai
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Risk Score ◽  
Research Funding ◽  
Antiplatelet Agents ◽  
Bleeding Risk ◽  
Initial Therapy ◽  
Line Treatment ◽  
Newly Diagnosed ◽  
Bleeding Events

Abstract Background: CLL is the most common form of adult leukemia in the Western World. It primarily affects the elderly with ~70% of patients diagnosed ≥65 years of age. Therapy is reserved until symptoms occur, when most patients have multiple chronic comorbidities including hypertension, arrhythmias, and other conditions that require the use of anticoagulants and/or antiplatelet agents. Understanding the frequency of use of these agents and bleeding events in routine clinical practice could provide additional insights on the real-world burden of the use of these drugs in patients with an underlying predisposition to bleeding due to CLL-related thrombocytopenia and other comorbidities. This is particularly relevant as several chemoimmunotherapy regimens used in CLL may have direct cardiotoxic and antiplatelet effects. Most importantly, emerging evidence suggests that some of the recently approved targeted agents may be associated with risk of cardiac arrhythmias or bleeding events. The mechanisms behind these events and the relations between them are largely unclear but affect the quality of life of CLL patients. The aim of this retrospective database study was to characterize the outcomes of newly diagnosed CLL patients in terms of: [1] incidence of atrial fibrillation (AFIB), [2] incidence of AFIB risk factors, [3] bleeding risk factors as measured by the 5-variable Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) risk score (which quantifies the risk of drug-associated hemorrhage), and [4] anticoagulant/antiplatelet drug usage over the course of their treatment. Methods: Based on administrative medical claims from the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases in the US, we identified adults diagnosed with CLL between 1/1/2004 - 4/30/2015. Patients selected for this study were required to have at least two treatment lines where the 2nd line treatment represented a change in initial therapy (index date = start of 1st line treatment). anticoagulant/antiplatelet use, incidence of AFIB (per 10,000 patient days), and ATRIA bleeding risk score were assessed during 1st and 2nd line treatment. Patients were continuously enrolled for ≥ 6 months (baseline) before index date, and followed until disenrollment from the health plan or 4/30/2015, whichever came first. Results: Of approximately 67 million adults (per year) in the database, we identified 2,335 adults with newly diagnosed CLL (mean age: 62 years; 66% male; 46% Medicare as primary payer) treated with antineoplastic therapy and followed for a mean of 35.3 months. The mean duration of first line treatment was 3.3 months, and 4.1 months for 2nd line treatment. Anticoagulant/antiplatelet use at baseline was common (25%), and use increased during 1st line (31%) and 2nd line (32%) treatment. During follow-up, the incidence of AFIB during 1st line and 2nd line treatment was 4.57 and 5.70/10,000 person days (95% CI: 3.7-5.5 and 4.8-6.6), respectively. The proportion of patients with ATRIA scores indicating moderate (ATRIA score 4) to high (ATRIA score ≥ 5) risk of bleeding increased from initial therapy (1st line treatment = 18%) to salvage therapy (2nd line treatment = 22%) [see Figure]. Conclusions: We provide the first real-world estimates of anticoagulant/antiplatelet use, AFIB, AFIB risk, and bleeding risk factors in adult patients newly diagnosed with CLL in the US. In our study, the use of anticoagulant/antiplatelet agents at diagnosis was common (25%) and increased over time from 1st to 2nd line treatment. Similarly, AFIB incidence and the ATRIA bleeding risk score also increased over the course of the natural disease progression. Since ATRIA scores of ≥ 5 correlate with a 5.8% annual risk of major hemorrhage, understanding the characteristics of the CLL patients at diagnosis and relapse will ultimately help optimize treatment selection based on the potential risks and benefits of each individual treatment regimen. These data, an evaluation of cardiac status, use of concomitant medications, and potential risk factors should be considered in the management of CLL. Disclosures Barrientos: Gilead: Research Funding; NIH/NCATS: Research Funding; ASH-AMFDP: Research Funding. Meyer:Truven Health Analytics: Employment. Song:Truven Health Analytics: Employment. Rai:Leon Levy Foundation: Research Funding; Nash Family Foundation: Research Funding; Nancy Marks Family Foundation: Research Funding; Karches Family Foundation: Research Funding.

Abstract 11: Selective Serotonin Reuptake Inhibitors Increase Major Hemorrhage Risk in Patients with Atrial Fibrillation Taking Warfarin

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Gene R Quinn ◽  
Daniel E Singer ◽  
Yuchiao Chang ◽  
Alan S Go ◽  
Leila Borowsky ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Relative Risk ◽  
Risk Score ◽  
Bleeding Risk ◽  
Adjusted Relative Risk ◽  
Major Hemorrhage ◽  
Fatal Hemorrhage ◽  
Hemorrhage Risk

Background: Several studies suggest that SSRIs may increase bleeding risk and drug information guides warn about a potential interaction between warfarin and SSRIs. However, the actual association between warfarin, SSRI exposure, and bleeding risk has not been well-quantified. In addition, prior studies have not controlled for baseline bleeding risk or warfarin control. Objective: To assess the association between SSRI exposure and major hemorrhage events in patients with nonvalvular atrial fibrillation taking warfarin. Methods: We used data from the ATRIA Study, a cohort of 13,559 adults with atrial fibrillation receiving care in a large integrated healthcare delivery system. The analysis was restricted to the 9186 patients who contributed follow-up time while taking warfarin. We assessed exposure to SSRIs using dispensing data from pharmacy databases. Additionally, we searched for exposure to tricyclic antidepressants (TCAs) as a control group. The primary outcome was hospitalization for major hemorrhage on warfarin, defined as fatal, hemorrhage into a critical anatomic space, or requiring transfusion of ≥ 2 units packed red blood cells. Clinical risk factors for hemorrhage were identified using administrative and computerized clinical databases and used to calculate an ATRIA bleeding risk score, a previously-developed measure of anticoagulation-associated bleeding risk. A multivariable Poisson regression model was then used to test the association between hemorrhage and SSRI or TCA exposure, adjusting for bleeding risk and time in an international normalized ratio (INR) range > 3. Results: We identified 461 major hemorrhages during a total of 32,888 person-years of follow-up on warfarin. Of these events, 45 events occurred during SSRI use, 12 events during TCA only use, and 404 events without either medication. Rates of hemorrhage were higher during periods of SSRI exposure compared with periods on no antidepressants (2.32 per 100 person-years vs. 1.35 per 100 person-years, p = <0.001). In contrast, rates of hemorrhage did not differ comparing TCA use to no antidepressants (1.30 per 100 person-years on TCAs, p = 0.93). The mean ATRIA bleeding risk score during SSRI exposure was higher than periods on no antidepressants (2.43 vs. 2.06, p<0.001); a higher bleeding risk score was also observed during TCA exposure (2.24 vs. 2.06, p<0.001). Exposure time while on SSRIs and TCAs was associated with more time where the INR > 3 (12.3% for SSRIs, 11.9% for TCAs, and 10.3% for neither, p<0.001). In a multivariable model adjusting for bleeding risk score and time with INRs > 3, SSRI exposure was associated with an increased rate of hemorrhage compared with no antidepressants (adjusted relative risk 1.60, 95% CI: 1.18-2.17), whereas TCAs were not associated with increased hemorrhage risk (adjusted relative risk 0.88, 95% CI: 0.50-1.57). Conclusions: The risk of major hemorrhage on warfarin was significantly higher during periods of SSRI therapy, but not TCA therapy, even after adjusting for bleeding risk factors and time in a supratherapeutic INR range. Closer monitoring of patients on SSRIs and anticoagulants should be considered.

4037Nurse counseling of patients with atrial fibrillation to improve compliance to oral anticoagulation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Chilian-Hof ◽  
S Schnupp ◽  
C Mahnkopf ◽  
J Brachmann ◽  
C Kleinecke
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Oral Anticoagulation ◽  
Vitamin K Antagonists ◽  
Randomised Trial ◽  
Female Gender ◽  
Bleeding Risk ◽  
Telephone Counseling ◽  
Bleeding Events

Abstract Background Atrial fibrillation (AF) is the most frequent arrhythmia with a prevalence of 1%–2% in the general population. Oral anticoagulation (OAC) is state-of-the art for preventions of thromboembolic events, in particular ischemic stroke, in patients with atrial fibrillation. Despite its proven benefit, numerous studies have documented under use of OAC for a variety of reasons. Purpose To establish a program of nurse counseling in patient with atrial fibrillation and treatment with oral anticoagulation. The program is designed to improve patients satisfaction, compliance to OAC, prevention of medication errors, ischemic and bleeding events. Methods Patients with atrial fibrillation and treatment with oral anticoagulation were prospectively identified at the department of cardiology of our clinic. They received a 30 minutes nurse counseling about oral anticoagulation during the hospital stay and another 30 minutes telephone counseling 3 months after inclusion. Furthermore, they received a brochure to inform about atrial fibrillation, oral anticoagulation and methods to improve medication compliance. Demographic characteristics with stroke and bleeding risk (CHA2DS2-VASc and HAS-BLED scores), as well as procedural data were systematically assessed in a predefined standardized way and captured in a dedicated database. Results Between June 2017 and January 2018, a total of 617 patients (female gender: 43.1%) with atrial fibrillation and oral anticoagulation received nurse counseling. Demographic and follow-up data of 204 patients (female gender: 85/204 (41.7%); mean age 69.7±17.3, CHA2DS2-VASc score 4.2±1.7, HAS-BLED score 2.8±0.37) were assessed in a dedicated database. Indication for OAC was paroxysmal and persistent/permanent AF in 110/204 (53.9%), 93/204 (45.6%) and others 17 (8.3%), respectively. 33/2014 (16.2%) were treated with vitamin K antagonists, and 172/204 (84.3%) with non-vitamin K antagonists. After a follow-up of 0.46±2.9 years and 187 patients-years the rates of cardiovascular death, major bleeding events and all-cause stroke and TIA were 1.07%, 2.14% and 1.61% per 100 patient-years. Conclusion Nurse counseling in patients with atrial fibrillation and treatment with oral anticoagulation has been established at the REGIOMED clinics, Germany. Its effectiveness in terms of quality of live, medication complications and cardiovascular events has to be proven in a randomised trial. Acknowledgement/Funding Daichi-Sankyo

P4742Evaluation of the HAS-BLED, ATRIA and ORBIT bleeding risk scores in newly diagnosed non-valvular atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Bergamaschi ◽  
A Stefanizzi ◽  
M Coriano ◽  
P Paolisso ◽  
I Magnani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Independent Predictor ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Newly Diagnosed ◽  
Bleeding Events ◽  
Hemorrhagic Events ◽  
Major Bleeding Events

Abstract Background Several risk scores have been proposed to assess the bleeding risk in patients with Atrial Fibrillation. Purpose To compare the efficacy of HAS-BLED, ATRIA and ORBIT scores to predict major bleedings in newly diagnosed non-valvular AF (NV-AF) treated with vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Methods We analyzed all consecutive patients with AF at our outpatient clinic from January to December 2017. Only those with new diagnosed NV-AF starting new anticoagulant therapy were enrolled. Major hemorrhagic events were defined according to the ISTH definition in non-surgical patients. Results Out of the 820 patients admitted with AF, 305 were newly diagnosed with NV-AF starting oral anticoagulation. Overall, 51.3% were male with a mean age of 72.6±13.7 years. Thirty-six patients (11.8%) started VKAs whereas 269 (88.2%) patients were treated with NOACs. The median follow-up time was 10.4±3.4 months. During follow-up, 123 (32.2%) bleeding events were recorded, 21 (17,1%) in the VKA group and 102 (82,9%) in the NOAC group. Eleven (2.9%) major bleeding events occurred: 5 (45.5%) in the VKA group and 6 (54.5%) in the NOAC group. Overall, patients with major hemorrhagic events showed a mean value of the scores significantly higher when compared to patients without such bleeding complications (HASBLED 3.4 vs 2.4 p=0.007; ATRIA 5.6 vs 2.4 p<0.001; ORBIT 3.6 vs 1.8 p<0,001). Conversely, when analyzing the VKA subgroup, only the ATRIA score was significantly higher in patients with major adverse events (7.4 vs 3.5 p<0.001; HAS-BLED: 4.4 vs 3.6 p=0.27; ORBIT 4.4 vs 2.9 p=0.13). An ATRIA score ≥4 identified patients at high risk of bleeding (29.4% vs. 0% events. respectively, p=0.04). In the NOAC group, patients with major bleeding events had higher mean values of ATRIA (4.0 vs 2.3 p=0.02) and ORBIT (2.8 vs 1.6 p=0,04) but not the HAS-BLED (2.5 vs 2.3 p=0.57) scores. Similarly, patients on NOACs with an ATRIA score ≥4 had higher rates of major bleedings (8.1% vs. 1.6% p=0,02). Comparing the single elements of the ATRIA score, only glomerular filtration rate <30 ml/min/1.73 mq was associated with major bleedings in the VKA group (p<0.001) whereas, in the NOAC group, anemia was strongly associated with bleeding events (p=0,02). In fact, multivariate analysis in the NOAC group showed that hemoglobin level at admission was an independent predictor for major bleeding events (OR 0.41, 95% CI 0.23–0.75, P=0.003). Conversely, in the VKA group, baseline creatinine level was an independent predictor for these events (OR 12.76, 95% CI 1.6–101.7, P=0.016). Conclusions The ATRIA score showed the best efficacy in predicting major bleeding events. Hemoglobin and creatinine levels at admission were independent predictors for major hemorrhagic events in the NOAC and in the VKA groups, respectively. The latter finding might be helpful in stratifying the hemorrhagic risk at the beginning of treatment.

P675Current status of anticoagulation in patients with breast cancer and atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Pardo Sanz ◽  
L M Rincon ◽  
P Guedes Ramallo ◽  
L Belarte ◽  
G De Lara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Atrial Fibrillation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Patients With Cancer ◽  
Oncologic Patients

Abstract Aims Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. We further evaluated the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with cancer. Methods The AMBER-AF registry is an observational multicentre study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain. 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. Mean follow-up was 3.1 years. Results Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. Lack of guidelines recommended therapies was more frequent among patients with cancer. Compared with patients without cancer, adjusted rates of stroke (hazard ratio [95% confidence interval]) in cancer patients were higher (1.56 [1.04–2.35]), whereas bleeding rates remained similar (1.25 [0.95–1.64]). Within the group of patients with cancer, the use of DOACs vs VKAs did not entail differences in the adjusted rates of stroke (0.91 [0.42–1.99]) or severe bleedings (1.53 [0.93–2.53]). Follow-up events Conclusions Antithrombotic management of AF frequently differs in patients with breast cancer. While breast cancer is associated with a higher risk of incident stroke, bleeding events remained similar. Patients with cancer treated with DOACs experienced similar rates of stroke and bleeding as those with VKAs.

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.

scholarly journals Risk factors for thromboembolic and bleeding events in anticoagulated patients with atrial fibrillation: the prospective, multicentre observational PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF)

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e022478 ◽  
Author(s):  
Miklos Rohla ◽  
Thomas W Weiss ◽  
Ladislav Pecen ◽  
Giuseppe Patti ◽  
Jolanta M Siller-Matula ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Prevention Of Thromboembolic Events ◽  
Major Bleeding Events ◽  
Anticoagulated Patients ◽  
European Registry

ObjectivesWe identified factors associated with thromboembolic and bleeding events in two contemporary cohorts of anticoagulated patients with atrial fibrillation (AF), treated with either vitamin K antagonists (VKA) or non-VKA oral anticoagulants (NOACs).DesignProspective, multicentre observational study.Setting461 centres in seven European countries.Participants5310 patients receiving a VKA (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF), derivation cohort) and 3156 patients receiving a NOAC (PREFER in AF Prolongation, validation cohort) for stroke prevention in AF.Outcome measuresRisk factors for thromboembolic events (ischaemic stroke, systemic embolism) and major bleeding (gastrointestinal bleeding, intracerebral haemorrhage and other life-threatening bleeding).ResultsThe mean age of patients enrolled in the PREFER in AF registry was 72±10 years, 40% were female and the mean CHA2DS2-VASc Score was 3.5±1.7. The incidence of thromboembolic and major bleeding events was 2.34% (95% CI 1.93% to 2.74%) and 2.84% (95% CI 2.41% to 3.33%) after 1-year of follow-up, respectively.Abnormal liver function, prior stroke or transient ischaemic attack, labile international normalised ratio (INR), concomitant therapy with antiplatelet or non-steroidal anti-inflammatory drugs, heart failure and older age (≥75 years) were independently associated with both thromboembolic and major bleeding events.With the exception of unstable INR values, these risk factors were validated in patients treated with NOACs (PREFER in AF Prolongation Study, 72±9 years, 40% female, CHA2DS2-VASc 3.3±1.6). For each single point decrease on a modifiable bleeding risk scale we observed a 30% lower risk for major bleeding events (OR 0.70, 95% CI 0.64 to 0.76, p<0.01) and a 28% lower rate of thromboembolic events (OR 0.72, 95% CI 0.66 to 0.82, p<0.01).ConclusionAttending to modifiable risk factors is an important treatment target in anticoagulated AF patients to reduce thromboembolic and bleeding events. Initiation of anticoagulation in those at risk of stroke should not be prevented by elevated bleeding risk scores.

Comparison of the CHADS2, CHA2DS2 -VASc and HAS-BLED scores for the prediction of clinically relevant bleeding in anticoagulated patients with atrial fibrillation: The AMADEUS trial

2013 ◽  
Vol 110 (11) ◽  
pp. 1074-1079 ◽  
Author(s):  
Stavros Apostolakis ◽  
Deirdre A. Lane ◽  
Harry Buller ◽  
Gregory Y. H. Lip
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Risk Assessment ◽  
Risk Score ◽  
Stroke Risk ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Net Reclassification Improvement ◽  
Anticoagulated Patients ◽  
Discriminatory Performance

SummaryMany of the risk factors for stroke in atrial fibrillation (AF) are also important risk factors for bleeding. We tested the hypothesis that the CHADS2 and CHA2DS2-VASc scores (used for stroke risk assessment) could be used to predict serious bleeding, and that these scores would compare well against the HAS-BLED score, which is a specific risk score designed for bleeding risk assessment. From the AMADEUS trial, we focused on the trial’s primary safety outcome for serious bleeding, which was “any clinically relevant bleeding”. The predictive value of HAS-BLED/CHADS2/CHA2DS2-VASc were compared by area under the curve (AUC, a measure of the c-index) and the Net Reclassification Improvement (NRI). Of 2,293 patients on VKA, 251 (11%) experienced at least one episode of “any clinically relevant bleeding” during an average 429 days follow up period. Incidence of “any clinically relevant bleeding” rose with increasing HAS-BLED/CHADS2/CHA2DS2-VASc scores, but was statistically significant only for HAS-BLED (p<0.0001). Only HAS-BLED demonstrated significant discriminatory performance for “any clinically relevant bleeding” (AUC 0.60, p<0.0001). There were significant AUC-differences between HAS-BLED (which had the highest AUC) and both CHADS2 (p<0.001) and CHA2DS2VASc (p=0.001). The HAS-BLED score also demonstrated significant NRI for the outcome of “any clinically relevant bleeding” when compared with CHADS2 (p=0.001) and CHA2DS2-VASc (p=0.04). In conclusion, the HAS-BLED score demonstrated significant discriminatory performance for “any clinically relevant bleeding” in anticoagulated patients with AF, whilst the CHADS2 and CHA2DS2-VASc scores did not. Bleeding risk assessment should be made using a specific bleeding risk score such as HAS-BLED, and the stroke risk scores such as CHADS2 or CHA2DS2-VASc scores should not be used.

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