Abstract 336: Anticoagulation Prescribing Patterns and Rates of Bleeding for People With Cancer and Atrial Fibrillation

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Sarah Barker ◽  
Adam L Cohen ◽  
Rashmee Shah ◽  
Anna Catino
Keyword(s):  
Atrial Fibrillation ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Prescribing Patterns ◽  
Secondary Outcome ◽  
Cancer Type ◽  
Bleeding Events ◽  
Thrombosis Risk ◽  
Increased Risk ◽  
Event Rates

Introduction: Atrial fibrillation (AF) is a major cause of stroke and increased mortality among people with cancer. People with cancer have a higher risk of developing AF at time of cancer diagnosis, prior to treatment, and after therapy than patients without cancer. AF management includes anticoagulation (AC) for stroke prophylaxis. Risk stratification tools are used to assess patients’ stroke and bleeding risk. However, such tools have not been validated in people with cancer. Therapeutic AC poses challenges due to increased risk of bleeding, platelet dysfunction, and drug interaction. Given this, therapeutic AC is often deferred despite potentially higher thrombosis risk. We sought to better understand practice patterns of therapeutic AC among people with cancer and AF. Hypothesis: We predicted reduced AC prescribing rates for AF among people with cancer despite high CHA 2 DS 2 -VASc score. Methods: We conducted a retrospective cohort study of people with cancer and AF at a single institution from 2010 to 2018. Cancer type was ascertained from an institutional registry; AF and other characteristics were determined from the electronic medical record. Patients were classified as anticoagulated based on medication orders and lists. Bleeding event rates were assessed using ICD billing codes. The primary outcome was rate of anticoagulant use with a secondary outcome of frequency of bleeding events. Results: We identified 2914 people with cancer and AF. 48% (1406 of 2914) were anticoagulated, and those prescribed AC were older (71.6 ± 9.7 vs. 69.8 ± 11, p<0.01), had higher CHA 2 DS 2 -VASc scores (3.7 ± 1.8 vs. 3.5 ± 1.9, p<0.01), and were more likely to have AF before cancer (49.7% vs. 39.7%p<0.01). People with breast (61%) and skin (66%) cancers had higher rates of AC, while people with hematologic (44%), brain (39%), lung (38%), and gastrointestinal (39%) cancers were less likely to be anticoagulated. Treated patients were more likely to experience a bleeding event (32% vs. 20%, p<0.01). Conclusions: There is a large group of people with cancer and high CHA 2 DS 2 -VASc scores who are not anticoagulated. Further research is needed to determine if this lack of AC is due to bleeding risk, lack of prescribing, or invalid use of CHA 2 DS 2 -VASc stratification in this population. Apparent bleeding rates are higher than previously published.

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 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.

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 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Matthew R Weir ◽  
Lloyd Haskell ◽  
Jeffrey S Berger ◽  
Veronica Ashton ◽  
François Laliberté ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Data Availability ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Claims Database ◽  
Increased Risk

Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.

scholarly journals Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Klaus K. Witte ◽  
Georgios Tsivgoulis ◽  
Matthew R. Reynolds ◽  
Stelios I. Tsintzos ◽  
Simon Eggington ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Recurrent Stroke ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Cost Savings ◽  
Embolic Stroke ◽  
Bleeding Events ◽  
Event Rates

Abstract Objective Prevention of recurrent stroke in patients with embolic stroke of undetermined source (ESUS) is challenging. The advent of safer anticoagulation in the form of direct oral anticoagulants (DOACs) has prompted exploration of prophylactic anticoagulation for all ESUS patients, rather than anticoagulating just those with documented atrial fibrillation (AF). However, recent trials have failed to demonstrate a clinical benefit, while observing increased bleeding. We modeled the economic impact of anticoagulating ESUS patients without documented AF across multiple geographies. Methods CRYSTAL-AF trial data were used to assess ischaemic stroke event rates in ESUS patients confirmed AF-free after long-term monitoring. Anticipated bleeding event rates (including both minor and major bleeds) with aspirin, dabigatran 150 mg, and rivaroxaban 20 mg were sourced from published meta-analyses, whilst a 30% ischaemic stroke reduction for both DOACs was assumed. Cost data for clinical events and pharmaceuticals were collected from the local payer perspective. Results Compared with aspirin, dabigatran and rivaroxaban resulted in 17.9 and 29.9 additional bleeding events per 100 patients over a patient’s lifetime, respectively. Despite incorporating into our model the proposed 30% reduction in ischaemic stroke risk, both DOACs were cost-additive over patient lifetime, as the costs of bleeding events and pharmaceuticals outweighed cost savings associated with the reduction in ischaemic strokes. DOACs added £5953–£7018 per patient (UK), €6683–€7368 (Netherlands), €4933–€9378 (Spain), AUD$5353–6539 (Australia) and $26,768–$32,259 (US) of payer cost depending on the agent prescribed. Additionally, in the U.S. patient pharmacy co-payments ranged from $2468–$12,844 depending on agent and patient plan. In all settings, cost-savings could not be demonstrated even when the modelling assumed 100% protection from recurrent ischaemic strokes, due to the very low underlying risk of recurrent ischaemic stroke in this population (1.27 per 100 patient-years). Conclusions Anticoagulation of non-AF patients may cause excess bleeds and add substantial costs for uncertain benefits, suggesting a personalised approach to anticoagulation in ESUS patients.

scholarly journals Hospitalization As a Risk Factor for Bleeding: The Medical Inpatients Thrombosis and Hemostasis (MITH) Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1915-1915
Author(s):  
Mansour Gergi ◽  
Katherine Wilkinson ◽  
Insu Koh ◽  
Jordan Munger ◽  
Hanny Al-Samkari ◽  
...  
Keyword(s):  
Primary Care ◽  
Predictive Value ◽  
Research Funding ◽  
Absolute Risk ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
The Past ◽  
Increased Risk ◽  
Age And Sex

Abstract Introduction: Bleeding risk is understudied in recently discharged medical patients and often less appreciated than venous thrombosis risk. Knowledge of both absolute and relative bleeding risk in people recently discharged from medical hospitalizations is needed to balance the risks of thrombosis and bleeding. We therefore quantified the relative and absolute risk of bleeding requiring hospitalization in patients recently discharged (up to 3 months) after a bleeding-free medical admission. Methods: We followed all primary care patients aged ≥18 at the University of Vermont Medical Center's primary care clinics from July 2010 to September 2019, capturing all hospitalizations and bleeding events that followed these hospitalizations for 3 months after discharge. Using International Classification of Disease (ICD) 9 and 10 discharge diagnoses, laboratory values, current procedure terminology (CPT) codes and flowsheet data for transfusion support, we developed and validated computable phenotypes to identify bleeding events. Validation was performed manually by abstracting 150 charts with bleeding events detected by the phenotype and 40 charts without a bleeding event. Present on admission (POA)-bleeding was defined if bleeding occurred &lt;24 hours after admission, and hospital-acquired (HA) if it occurred ≥24 hours after admission. For this analysis, our outcome was POA-bleeding. Bleeding risk was estimated using successive 1-month intervals after discharge as a time-varying covariate in age- and sex-adjusted Cox proportional hazard models. The reference group was bleeding risk in people with no hospitalization in the prior 3 months. HA-bleeding occurring within 3 months of a previous hospitalization were not grouped with the prior hospitalization. Results: From 2010-2019, among 67,571 people with a mean age of 48 years (56.7% female) followed for a median of 6.2 years, there were a total of 14,266 medical hospitalizations and 1,784 hospitalized bleeding events (568 HA and 1216 POA). The bleeding computable phenotype had a positive predictive value of 79% and a negative predictive value of &gt;99%. The rate of bleeding in people with no hospitalizations within the past 3 months was 2.88 per 1000 person-years. Over the 1 month after discharge, the rate was 153.8 per 1000 person-years decreasing to 61 per 1000 person-years in the second month after discharge and 29 per 1000 person-years in the third month after discharge. The age- and sex-adjusted HR for bleeding was 26.9 the first month after discharged and decreased respectively to 15.3 and 8 over successive 1-month intervals after discharge, relative to those with no hospitalization in the past 3 months (Table). Conclusion: In this northern Vermont population, the three months after a medical hospitalization was associated with dramatically increased risk of hospitalization for bleeding compared to people with no recent hospitalizations. Findings demonstrate how common bleeding is after hospitalization and emphasize on the need to develop methods to quantify bleeding risk. Figure 1 Figure 1. Disclosures Al-Samkari: Novartis: Consultancy; Moderna: Consultancy; Argenx: Consultancy; Rigel: Consultancy; Amgen: Research Funding; Dova/Sobi: Consultancy, Research Funding; Agios: Consultancy, Research Funding.

scholarly journals Comparison of bleeding risk scores in patients with atrial fibrillation and cancer

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
D Pastori ◽  
A Marang ◽  
A Bisson ◽  
J Herbert ◽  
GYH Lip ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Bleeding Risk ◽  
Hazard Ratio ◽  
Risk Scores ◽  
Cancer Type ◽  
Gi Bleeding ◽  
Bleeding Events ◽  
Patients With Cancer ◽  
Funding Sources ◽  
Bleeding Score

Abstract Funding Acknowledgements Type of funding sources: None. Background. Cancer may increase bleeding risk in atrial fibrillation (AF), but the association between cancer type and specific bleeding events has been scarcely investigated. Furthermore, the performance of bleeding risk scores in this high-risk subgroup of patients is unclear. Purpose. To describe the incidence rate (IR) of major (MB), gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH) according to cancer types. We also investigated the performance of HAS-BLED, ATRIA and ORBIT scores.  Methods Observational retrospective cohort study including 399,344 patients with AF and cancer. Results. Mean age was 77.9 ± 10.2 years and 63.2% were men. During 2.0 years follow-up, the IR of MB was as high as 8.41%/y, GI bleeding was 3.61%/y and ICH 1.33%/y. MBs were more frequent in liver (12.68%/y), leukaemia (12.39%/y), pancreas (11.71%/y), bladder (11.67%/y) and myeloma (11.64%/y). GI bleedings were highest in liver (7.54%/y), pancreas (7.42%/y) and gastric (5.51%/y). ICH was highest in leukaemia (1.89%/y), myeloma (1.52%/y), lymphoma/liver (1.45%/y) and pancreas (1.41%/y) cancer. The Table shows the hazard ratio and AUC values for each bleeding score. All the three scores significantly associated with bleeding outcomes, with the HAS-BLED score performing better than others for ICH prediction, and the ORBIT score predicting MB and GI bleedings (p &lt; 0.0001 for all AUC comparisons). Conclusions. Cancer increases the risk of bleeding in patients with cancer, with specific differences according to each cancer type. HAS-BLED score showed the best predictive value for ICH and the ORBIT score for MB and GI bleeding. MB GI bleeding ICH Hazard Ratio (95%CI) HASBLED score≥3 6.575 (6.390-6.765) 5.735 (5.502-5.978) 5.803 (5.416-6.218) ATRIA score≥5 5.372 (5.241-5.506) 3.617 (3.499-3.739) 1.469 (1.403-1.538) ORBIT score≥4 13.326 (12.977-13.686) 7.453 (7.202-7.712) 2.578 (2.463-2.699) AUC (95%CI) HASBLED score≥3 0.716 (0.714-0.718) 0.702 (0.699-0.704) 0.698 (0.694-0.702) ATRIA score≥5 0.700 (0.698-0.702) 0.662 (0.659-0.665) 0.563 (0.557-0.568) ORBIT score≥4 0.805 (0.804-0.807) 0.756 (0.753-0.758) 0.641 (0.635-0.646) AUC Difference (95% CI) HASBLED≥3 vs ATRIA≥5 0.016 (0.014-0.018) 0.040 (0.037-0.042) 0.136 (0.133-0.138) HASBLED≥3 vs ORBIT≥4 -0.089 (-0.091–0.087) -0.054 (-0.056–0.052) 0.057 (0.055-0.059) ATRIA≥5 vsORBIT≥4 -0.106 (-0.108–0.104) -0.094 (-0.095–0.092) -0.078 (-0.080–0.076)

scholarly journals Comparison of the HAS-BLED, ORBIT and ATRIA bleeding risk scores in 399,344 patients with atrial fibrillation and cancer

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
D Pastori ◽  
A Marang ◽  
A Bisson ◽  
J Herbert ◽  
G.Y.H Lip ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Cancer Type ◽  
Gi Bleeding ◽  
Bleeding Events ◽  
Patients With Cancer ◽  
Funding Sources ◽  
Hazard Ratios

Abstract Background The presence of cancer worsens the prognosis of patients with atrial fibrillation (AF). However, the association between cancer type and specific bleeding events has been scarcely investigated. Furthermore, the performance of bleeding risk scores, such HAS-BLED, ORBIT and ATRIA, in this high-risk subgroup of AF patients is unclear. Purpose To investigate the incidence rate (IR) of major, gastrointestinal (GI) bleeding and intracranial haemorrhage (ICH) according to cancer types. We also investigated the performance of HAS-BLED, ATRIA and ORBIT scores. HASBLED ≥3, ATRIA ≥5 and ORBIT ≥4 were defined as high-risk. Methods Observational retrospective cohort study including 399,344 patients with AF and cancer. Results Mean age was 77.9±10.2 years and 63.2% were men. During a mean follow-up of 2.0 years, the IR of major bleeding was as high as 8.41%/year, GI bleeding was 3.61%/year and ICH 1.33%/year. Major bleedings were more frequent in liver (12.68%/year), leukaemia (12.39%/year), pancreas (11.71%/year), bladder (11.67%/year) and myeloma (11.64%/year). GI bleeding were highest in liver (7.54%/year), pancreas (7.42%/year) and gastric (5.51%/year). The highest IR of ICH was found in leukaemia (1.89%/year), myeloma (1.52%/year), lymphoma and liver (1.45%/year) and pancreas cancer (1.41%/year). Figure 1 shows the hazard ratios and AUC values for the three scores against each endpoint. All the three scores were significantly associated with major, GI and ICH. The HAS-BLED score performed better than others for ICH prediction, while the ORBIT score showed the best predictivity for major and GI bleedings (p&lt;0.0001 for all AUC comparisons) Conclusions Cancer increases the risk of bleeding in patients with cancer, with specific differences according to each cancer type. HAS-BLED score identified patients at highest risk for ICH and the ORBIT score for major and GI bleeding. FUNDunding Acknowledgement Type of funding sources: None. Figure 1

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.

scholarly journals Abstract MP4: Ticagrelor Plus Aspirin Versus Aspirin Alone in Acute Ischemic Stroke or TIA - Analysis of Bleeding Events in the THALES Trial

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Carlos Molina ◽  
Pierre Amarenco ◽  
Per Ladenvall ◽  
Maria Aunes ◽  
Hans Denison ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
High Risk ◽  
Acute Ischemic Stroke ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Severe Bleeding ◽  
Bleeding Events ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Aspirin Group

Introduction: In the THALES trial, ticagrelor and aspirin was superior to aspirin alone in reducing the primary endpoint of stroke or death, and subsequent disabling strokes, but increased risk of bleeding, as expected for dual antiplatelet therapy. Aim: Present the bleeding profile of ticagrelor in combination with aspirin in patients with acute cerebrovascular events. Methods: The THALES trial randomized patients with non-cardioembolic, non-severe ischemic stroke (NIHSS≤5) or high-risk TIA to ticagrelor (180mg loading dose on day 1 followed by 90mg twice daily until day 30) or placebo within 24h of symptom onset in 28 countries. All patients received aspirin 300-325mg on day 1 followed by 75-100mg daily until day 30. Primary safety endpoint was time to severe bleeding, defined by GUSTO criteria, within 30 days. Analyses were by intention to treat. (ClinicalTrials.gov number, NCT03354429). Results: Among 11016 patients randomized, 28 (0.5%) in the ticagrelor+aspirin group (T+A) and 7 (0.1%) in the aspirin group (A) had a severe bleeding event; HR 3.99 (1.74-9.14); p=0.001. Among these, 22 (0.4%) (T+A) vs 6 (0.1%) (A) were fatal or intracranial hemorrhages (ICHs) and 6 (0.1%) (T+A) vs 1 (<0.1%) (A) non-fatal events with hemodynamic compromise. ICHs included 10 (0.2%) (T+A) vs 2 (<0.1%) (A) hemorrhagic strokes and 4 (0.1%) (T+A) vs 2 (<0.1%) (A) symptomatic haemorrhagic transformations of ischemic stroke and other ICHs. Most severe bleeding events were spontaneous; 1 (T+A) and 2 (A) were traumatic and 1 in each treatment group were procedural. No predefined subgroup was associated with severe bleeding risk though analyses were limited by a small number of events. Moderate/severe bleeding events occurred in 36 (0.7%) (T+A) vs 11 (0.2%) (A) patients. Bleeding leading to discontinuation occurred in 152 (2.8%) (T+A) vs 32 (0.6%) (A) patients. Conclusion: While the rate of severe bleeding in the patients with acute ischemic stroke or TIA was low, patients randomized to receive ticagrelor more often experienced severe bleeding events. No subgroup with different bleeding risk could be identified. Given the high risk of disability following a subsequent stroke, the benefit of adding ticagrelor to aspirin in reducing subsequent stroke appears to outweigh the risk of bleeding.

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