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.

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.

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.

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.

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.

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.

scholarly journals Identifying Predictors for Bleeding in Hospitalized Cancer Patients: A Cohort Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 529-529
Author(s):  
Rushad Patell ◽  
Alejandra Gutierrez ◽  
Lisa Rybicki ◽  
Alok A. Khorana
Keyword(s):  
Risk Factors ◽  
Logistic Regression ◽  
Cohort Study ◽  
Length Of Stay ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Reason For Admission

Abstract Background: Bleeding and thrombosis are both major complications of hospitalization in cancer patients. We have previously shown that rate of inpatient venous thromboembolism (VTE) is 4% in a general oncology population (Patell et al, ASCO 2016). Concern regarding bleeding risk may reduce compliance with thromboprophylaxis. A better understanding of predictors of bleeding could optimize use of prophylaxis but there remain major knowledge gaps regarding risk factors for in-hospital bleeding in cancer patients. We assessed major and clinically relevant bleeding incidence and identified risk factors at admission associated with subsequent in-hospital bleeding risk in a cohort of hospitalized cancer patients. Methods: We conducted a retrospective cohort study of consecutive adults admitted to general oncology floor at Cleveland Clinic from 2013-14 (n= 3466). Patients were excluded for bleeding on admission (108). Data collected included demographics, body mass index (BMI), cancer type, length of stay (LOS), use of anticoagulants and baseline laboratory values (+48 hours). Bleeding was assessed using the ISTH definitions of major bleeding and clinically relevant non-major bleeding [Schulman 2005 and Decosus 2011]. Data were collected using an electronic query system of electronic health records. Reason for admission and all bleeding events were confirmed by manual chart review. Univariate risk factors were identified with logistic regression analysis. Multivariable risk factors were identified with stepwise logistic regression and confirmed with bootstrap analysis. Results are summarized as odds ratio (OR) and 95% confidence interval (CI). Results: The study population comprised 3,358 patients of whom 69 (2.1%) developed major and clinically relevant non-major bleeding during hospitalization. Median age was 62 (range, 19-98) years and 56% were male. Median length of stay (LOS) was 5 (range, 0-152) days. The majority of bleeding events were either gastrointestinal (N=30, 43%) or intracranial (N= 13, 19%). In univariate analysis, luminal gastrointestinal (GI) cancers (OR 4.2, CI 2.4-7.5, P<0.001), anemia as reason for admission (OR 9.1, CI 5.1-16.4, P<0.001), thrombocytopenia (OR 1.6, CI 1.0-2.6, P=0.046), leukocytosis (OR 2.1, CI 1.2-3.7,P=0.005), low hemoglobin (OR 3.2, CI 1.4-7.1 P=0.003), BMI ≥ 40 kg/m2 (OR 2.6, CI 1.1-5.94, P=0.018) and anticoagulant use on admission (OR 0.4, CI 0.3-0.8, P=0.004) were significantly associated with bleeding. In multivariable analysis, anemia as the reason for admission, primary cancer site, BMI>40, thrombocytopenia and low hemoglobin on admission remained predictive of bleeding (table 1). Conclusion: The incidence of major and clinically relevant bleeding in a large population of hospitalized cancer patients was about 2%, compared to incidence of inpatient VTE in a similar population of 4%. Risk factors at admission included type of cancer and morbid obesity. Improved prediction of bleeding risk can assist physicians in optimizing selection of thromboprophylaxis in this population that is also at increased risk of VTE. Disclosures Khorana: Sanofi: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding.

scholarly journals Cancer incidence during follow-up in patients with new-onset atrial fibrillation treated with DOACs and its impact on bleeding risk

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Angeli ◽  
L Bartoli ◽  
M Fabrizio ◽  
L Bergamaschi ◽  
I Magnani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Assessment ◽  
Oral Anticoagulant ◽  
Metastatic Cancer ◽  
Bleeding Risk ◽  
Newly Diagnosed ◽  
Bleeding Events ◽  
Onset Atrial Fibrillation ◽  
New Onset

Abstract Background Cancer is increasingly recognized as strictly related to atrial fibrillation (AF). In patients with AF, the relationship between cancer and cardioembolic or bleeding risk during oral anticoagulant therapy is unknown. Purpose To assess the bleeding and ischaemic burden of a baseline or newly diagnosed cancer in patients treated with direct oral anticoagulants (DOACs) for non-valvular atrial fibrillation (NVAF). Methods All consecutive patients treated with DOACs were enrolled among those with new-onset atrial fibrillation and indication for oral anticoagulant between January 2017 and March 2019. During follow-up, bleeding events, newly diagnosed primitive or metastatic malignancy and major cardiovascular events (MACE) were evaluated. At baseline, CHA2DS2-VASc, HAS-BLED, ATRIA, and ORBIT scores were used to assess the hemorrhagic and ischaemic risk. Major bleedings (MB) were defined according to the ISTH definition. Anemia was defined as haemoglobin levels below 11 g/dL in women and 12 mg/dL in men. Results 1258 patients constituted the study population and followed for a mean time of 21.6±9.5 months. Overall, 66 patients (5.2%) were affected by malignant neoplasia at baseline, whereas 59 (4.7%) were diagnosed with a malignancy during follow-up. Among baseline characteristics, anemia was associated with cancer at enrolment (43.9% vs 22.5%, p&lt;0.001) but not at follow up (29.3% vs 23.4%, p=0.341). MACEs were not associated with cancer at baseline (5.3% vs 5.2%, p=1.0) and at follow up (5% vs 4.9%, p=1.0). No association was observed between major ischaemic events and cancer at enrolment or follow up (5.3% vs 4.4%, p=0.83 and 4.4% vs 5%, p=0.82). Despite no statistically significant differences in haemorrhagic risk at baseline, the overall bleeding events and MB were associated with newly diagnosed cancer (9.2% vs 3.9%, p=0.001 and 13.8% vs 4.5%, p=0.001, respectively) but not at baseline (5.2% vs 5.5%, p=0.82 and 9.2% vs 5.2%, p=0.162). At multivariate analysis adjusted for age, hypertension and renal function, anemia and a newly diagnosed cancer during follow up remained independent predictors of MB (respectively, HR 1.27, 95% CI 1.52–1.06, p=0.009 and HR 3.53, 95% CI 7.71–1.62, p=0.001). Conclusion Bleeding risk assessment is an ongoing challenge in patients with NVAF on DOACs. During follow-up, newly diagnosed primitive or metastatic cancer is a strong predictor of bleeding regardless of baseline haemorrhagic risk assessment. In contrast, such association is not observed with malignancy at baseline. A proper diagnosis and treatment could therefore decrease cancer-related bleeding risk. On the contrary, our study shows that cancer is not an ischaemic risk modifier, either diagnosed at baseline or follow-up. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Factors associated with non-prescription of oral anticoagulant treatment in non-valvular atrial fibrillation patients with dementia: a CPRD–HES study

2020 ◽  
Vol 49 (4) ◽  
pp. 679-682 ◽  
Author(s):  
Megan Besford ◽  
Sophie Graham ◽  
Cormac Sammon ◽  
Faisal Mehmud ◽  
Victoria Allan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Oral Anticoagulant ◽  
Treatment Guidelines ◽  
Bleeding Risk ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Newly Diagnosed ◽  
Factors Associated ◽  
Dementia Patients

Abstract Dementia is a common comorbidity in patients with atrial fibrillation (AF) and treatment guidelines recommend oral anticoagulant (OAC) therapy for AF patients with dementia unless concordance cannot be ensured by the caregiver. Despite this, the literature reports a low prescribing of OAC treatment in these patients. This study investigated possible factors associated with non-prescribing of OAC treatment in dementia patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at age ≥ 65 years between 2013 and 2017 using the Clinical Practice Research Datalink and Hospital Episodes Statistics databases. Of 1090 dementia patients newly diagnosed with NVAF, 693 (63.6%) patients did not have a prescription for an OAC in the year following their diagnosis. The likelihood of experiencing a thromboembolic event was high, with 97% of the population having a CHA2DS2-VASc score &gt; 2; however, little difference in the presence of stroke risk factors was observed between the prescribed and non-prescribed groups. The presence of bleeding risk factors was high; only 28 (2.6%) of patients did not have a previous fall or a HAS-BLED bleeding risk factor. A history of falls [OR = 0.76, 95% confidence intervals (CIs) (0.58, 0.98)], previous major bleed [OR = 0.56, 95% CI (0.43, 0.73)] and care home residence [OR = 0.47, 95% CI (0.30, 0.74)] were associated with not having an OAC prescription. The results suggest that dementia patients with NVAF and certain risk bleeding risk factors are less likely to be prescribed an OAC. Further work is needed to establish possible relationships between bleeding risk factors and other potential drivers of OAC prescribing.

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.

Abstract 217: How well does the CHADS 2 Stroke Risk Score Predict Major Hemorrhage in Patients with Atrial Fibrillation?

2013 ◽  
Vol 6 (suppl_1) ◽  
Author(s):  
Gene R Quinn ◽  
Daniel E Singer ◽  
Alan S Go ◽  
Yuchiao Chang ◽  
Leila Borowsky ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Risk Score ◽  
Stroke Risk ◽  
Healthcare Delivery ◽  
Bleeding Risk ◽  
Major Hemorrhage ◽  
Net Reclassification Improvement ◽  
Hemorrhage Risk ◽  
Better Than

Background: The decision on whether or not to use anticoagulants for atrial fibrillation depends on estimating a patient’s risk of stroke compared to their risk of bleeding. The CHADS 2 risk score is widely used to predict the risk of stroke in patients with atrial fibrillation. Several of the risk factors in CHADS 2 have also been associated with hemorrhage risk, raising the possibility that CHADS 2 could also be used to predict warfarin-associated hemorrhage. Objective: To determine whether the CHADS 2 stroke risk scheme can be used to predict hemorrhage in patients with atrial fibrillation and to compare the predictive ability of CHADS 2 with a risk score specifically designed to predict warfarin-related hemorrhage. 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 cohort was divided into on-warfarin and off-warfarin periods. Clinical risk factors were obtained from computerized medical databases and used to calculate a CHADS 2 risk score (congestive heart failure, hypertension, age≥75, diabetes, and prior stroke) as well as a previously developed measure of anticoagulation-associated bleeding risk, the ATRIA bleeding risk score (anemia, severe renal disease, age≥75, prior bleed, and hypertension). The primary outcome was hospitalization for major hemorrhage, validated through chart review. The performance of the CHADS 2 and ATRIA scores was compared by c -index and net reclassification improvement. Results: We identified 170 major hemorrhages during 15,300 person-years of follow-up on warfarin, and 162 hemorrhages during 15,530 person-years off warfarin. The CHADS 2 risk score predicted hemorrhage risk better than chance in both warfarin and non-warfarin exposed groups, with a c- index of 0.67 [95% CI = 0.64 - 0.71] and 0.65 [95% CI = 0.62-0.67], respectively. However, the ATRIA bleeding risk score predicted major hemorrhage events better than CHADS 2 , with a c -index of 0.74 [95% CI = 0.72-0.76] for warfarin users and 0.77 [95% CI = 0.75-0.80] for non-warfarin users. The ATRIA bleeding risk score also had better net reclassification improvement than CHADS 2, 35.6% for warfarin users and 26.8% for non-warfarin users. Conclusions: Although some clinical markers of stroke risk such as those included in the CHADS 2 risk score are also associated with increased hemorrhage risk, the CHADS 2 risk score should not be used instead of a validated hemorrhage risk tool to estimate hemorrhage risk.

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