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.

A Systematic Review of Anticoagulation Strategies for Patients With Atrial Fibrillation in Critical Care.

2021 ◽  
Author(s):  
Alexandra Jayne Nelson ◽  
Brian W Johnston ◽  
Alicia Achiaa Charlotte Waite ◽  
Gedeon Lemma ◽  
Ingeborg Dorothea Welters
Keyword(s):  
Atrial Fibrillation ◽  
Critical Care ◽  
Critically Ill ◽  
Major Bleeding ◽  
Critically Ill Patients ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
The Impact ◽  
Anticoagulated Patients

Background. Atrial fibrillation (AF) is the most common cardiac arrhythmia in critically ill patients. There is a paucity of data assessing the impact of anticoagulation strategies on clinical outcomes for general critical care patients with AF. Our aim was to assess the existing literature to evaluate the effectiveness of anticoagulation strategies used in critical care for AF. Methodology. A systematic literature search was conducted using MEDLINE, EMBASE, CENTRAL and PubMed databases. Studies reporting anticoagulation strategies for AF in adults admitted to a general critical care setting were assessed for inclusion. Results. Four studies were selected for data extraction. A total of 44087 patients were identified with AF, of which 17.8-49.4% received anticoagulation. The reported incidence of thromboembolic events was 0-1.4% for anticoagulated patients, and 0-1.3% in non-anticoagulated patients. Major bleeding events were reported in three studies and occurred in 7.2-8.6% of the anticoagulated patients and up to 7.1% of the non-anticoagulated patients. Conclusions. There was an increased incidence of major bleeding events in anticoagulated patients with AF in critical care compared to non-anticoagulated patients. There was no significant difference in the incidence of reported thromboembolic events within studies, between patients who did and did not receive anticoagulation. However, the outcomes reported within studies were not standardised, therefore, the generalisability of our results to the general critical care population remains unclear. Further data is required to facilitate an evidence-based assessment of the risks and benefits of anticoagulation for critically ill patients with AF.

scholarly journals The prognostic potential of growth differentiation factor-15 on bleeding events and patient outcome after cardiac surgery

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
N Kazem ◽  
A Hammer ◽  
L Koller ◽  
F Hofer ◽  
B Steinlechner ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Cardiac Surgery ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Growth Differentiation Factor 15 ◽  
All Cause Mortality

Abstract Background GDF-15 (growth/differentiation factor 15) is induced by myocardial stretch, volume overload, inflammation and oxidative stress. Its expression is tightly linked with cardiovascular events as well as the risk for major bleeding and all-cause mortality. Objective The objective of the present study was to elucidate the prognostic potential of GDF-15 in patients after cardiac surgery. Methods 504 patients undergoing elective cardiac valve and/or coronary artery bypass graft surgery were prospectively enrolled. GDF-15 levels were measured prior surgery to evaluate the impact on bleeding events, thromboembolic events and mortality. Results Preoperative GDF-15 was associated with the primary endpoint of intra- and postoperative red blood cell transfusion (for bleeding risk factors adjusted [adj] OR [odds ratio] per 1-SD [standard deviation] of 1.62 [95% CI: 1.31–2.00]; p&lt;0.001) and postoperative atrial fibrillation (for atrial fibrillation risk factors adj. OR per 1-SD of 1.49 [95% CI: 1.22–1.81]; p&lt;0.001). Higher concentrations of GDF-15 were observed in patients reaching the secondary endpoint of major or clinically relevant minor bleeding (for bleeding risk factors adj. OR per 1-SD of 1.70 [95% CI: 1.05–2.75]; p=0.030) during the 1stpostoperative year, but not for thromboembolic events. GDF-15 was a predictor for cardiovascular mortality (for comorbidities adj. HR [hazard ratio] per 1-SD of 1.67 [95% CI: 1.23–2.27]; p=0.001) and all-cause mortality (for comorbidities adj. HR per 1-SD of 1.55 [95% CI: 1.19–2.01]; p=0.001). A combined risk model of GDF-15 and EuroSCORE II outperformed the EuroSCORE II alone for long-term survival (c-index: 0.75 [95% CI: 0.70–0.80], p=0.046; net reclassification improvement: 33.6%, p&lt;0.001). Conclusion Preoperative GDF-15 concentration is an independent predictor for intra- and postoperative major bleeding, major bleeding during the first year and for long-term cardiovascular or all-cause mortality after cardiac surgery. FUNDunding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Medical University of Vienna Central illustration

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.

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.

Use of Simplified HAS-BLED Score for Predicting Bleeding Events in Anticoagulated Patients with Atrial Fibrillation

2021 ◽  
Vol 104 (5) ◽  
pp. 802-806
Keyword(s):  
Atrial Fibrillation ◽  
Risk Prediction ◽  
Major Bleeding ◽  
Predictive Value ◽  
Statistical Significance ◽  
Bleeding Risk ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Sensitivity Specificity ◽  
Anticoagulated Patients

Objective: To demonstrate bleeding risk prediction of simplified HAS-BLED (sHAS-BLED) score in anticoagulated patients with atrial fibrillation (AF). Materials and Methods: AF patients receiving warfarin were retrospectively recruited in Central Chest Institute of Thailand between October 2012 and December 2017. The main outcome was total bleeding including major bleeding, clinically relevant non-major bleeding or minor bleeding. The chi-square test or Fisher’s exact test was used to compare the main outcome between sHAS-BLED and conventional HAS-BLED (cHAS-BLED) scores. A sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of sHAS-BLED were calculated. The discrimination performances of sHAS-BLED and cHAS-BLED scores were demonstrated with c-statistics. Results: One hundred ten patients were recruited. The mean age was 70.53±9.58 years. The average sHAS-BLED and cHAS-BLED scores were 2.23±0.79 and 1.95±0.83, respectively. The patients with sHAS-BLED score of 3 or more had 15 total bleeding events (37.50%) while those with score of less than 3 had 13 total bleeding events (18.57%). Those with sHAS-BLED score of 3 or more had more total bleeding than those with score of less than 3 with statistical significance (odds ratio 2.63; 95% CI 1.09 to 6.25; p=0.049). A sensitivity, specificity, PPV, and NPV of sHAS-BLED score were 53.57%, 69.51%, 37.50%, and 81.43%, respectively. The discrimination performances of sHAS-BLED and cHAS-BLED scores were demonstrated with c-statistics of 0.65 and 0.67, respectively. Conclusion: The sHAS-BLED score can be used for bleeding risk prediction in anticoagulated AF patients compared with cHAS-BLED score. Keywords: Simplified HAS-BLED, Atrial fibrillation, Anticoagulant, Bleeding, SAMe-TT₂R₂

P10 A possible link between sarcopenia and major bleeding risk among patients with atrial fibrillation treated with oral anticoagulation undergoing coronary stenting

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
K Tsuchida ◽  
K Tanaka ◽  
K Nakano ◽  
R Akagawa ◽  
N Oyanagi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Skeletal Muscle ◽  
Muscle Mass ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Skeletal Muscle Mass ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Background/Introduction In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with stent implantation, oral anticoagulation (OAC) plus dual antiplatelet therapy (DAPT) increases the risk of bleeding. The PRECISE-DAPT (P-DAPT) and DAPT scores were created to predict increased bleeding versus ischemic risk in patients undergoing DAPT. However, not much information is available on predicting bleeding risk associated with OAC concomitant with DAPT in patients with AF treated with coronary stents. Physical frailty or sarcopenia is considered an emerging predictor for bleeding in AF patients. Purpose To investigate the relationship between skeletal muscle mass and major bleeding risk in AF patients undergoing PCI and subsequent OAC and DAPT. Methods A total of 1,234 consecutive patients after PCI using newer-generation drug eluting stents were evaluated. An anti-thrombotic regimen without OAC was given to 1,077 patients, whereas OAC was required in 157 patients (12.7%) including AF (n = 96). The P-DAPT, DAPT, and HAS-BLED scores were calculated for each of the patients. Any out-of-hospital major bleeding events were identified based on BARC criteria during a median follow-up of 2.9 years. The fat-free mass index (FFMI; kg/m2) was calculated to evaluate skeletal muscle mass as follows: (7.38 + 0.02908 × urinary creatinine (mg/day)) / (height squared (m2)). A Cox proportional hazards model was used to test the significance of the FFMI and these risk scores as predictors of major bleeding, defined as BARC 3 or 5 events in AF patients. The receiver operating characteristic curve (ROC) analyses were used to examine the predictive ability of the FFMI and these scores to identify patients with major bleeding events. Results Major bleeding events were observed in 9 (9.3%) patients. Major bleeding was associated with a lower FFMI (hazard ratio [HR] 0.53; 95% confidence interval [CI] 0.36-0.79; p = 0.002), and higher P-DAPT score (HR, 1.07; 95% CI, 1.02-1.11; p = 0.003), but not with the DAPT (HR, 0.71; 95% CI, 0.45-1.12; p = 0.147) and the HAS-BLED score (HR, 1.00; 95% CI, 0.48-2.09; p = 0.990). In the non-OAC cohort, major bleeding was related to a higher P-DAPT score (HR, 1.05; 95% CI, 1.02-1.07; p &lt; 0.0001), but the FFMI (HR, 0.89; 95% CI, 0.73-1.09; p = 0.265) and the DAPT score were not correlated. C-statistics for major bleeding events were 0.82 (95% CI, 0.71-0.93, p = 0.001) for the FFMI and 0.79 (95% CI, 0.68-0.90, p = 0.004) for the P-DAPT score. Conclusions Assessment of the FFMI for screening sarcopenia is useful to predict major bleedings specifically in patients with AF undergoing coronary stenting. Both the FFMI and P-DAPT could successfully predict major bleedings in AF patients after PCI. Whether novel bleeding risk scores combined with measuring body composition adequately identify high risk patients needs to be validated.

scholarly journals Reclassification, Thromboembolic, and Major Bleeding Outcomes Using Different mates of Renal Function in Anticoagulated Patients With Atrial Fibrillation: Insights From the PREFER-in-AF and PREFER-in-AF Prolongation Registries

2021 ◽  
Author(s):  
Miklos Rohla ◽  
Ladislav Pecen ◽  
Roberto Cemin ◽  
Giuseppe Patti ◽  
Jolanta M. Siller-Matula ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Dose Reduction ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Disease Epidemiology ◽  
Anticoagulated Patients

Background: The Cockcroft-Gault formula is recommended to determine a renal indication for dose reduction of dabigatran, edoxaban, and rivaroxaban. Nephrology guidelines now recommend the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulae as more accurate estimates of glomerular filtration rate. Methods: We analyzed anticoagulated patients with atrial fibrillation who were enrolled in the Prevention of Thromboembolic Events – European Registry in Atrial Fibrillation (PREFER in AF). The proportion of patients with dissimilar renal dosing indications was assessed when applying Cockcroft-Gault, MDRD, or CKD-EPI. Thromboembolic and major bleeding events at 1 year were compared in patients in whom Cockcroft-Gault and CKD-EPI provided concordant or discordant results around a threshold of 50 mL/minute. Results: Out of 1288 patients with atrial fibrillation with chronic kidney disease in whom Cockcroft-Gault suggested a dose reduction of dabigatran, edoxaban, or rivaroxaban (creatinine clearance ≤50 mL/minutes), 19% and 16% were reclassified to the respective higher doses, and 24% and 23% to the respective lower doses by applying the MDRD and CKD-EPI formulae, respectively. In patients potentially receiving a different dose of dabigatran, edoxaban, or rivaroxaban when using CKD-EPI, we observed an excess of thromboembolic events (4.1% versus 0.8%; odds ratio, 5.5 [95% CI, 1.5–20.8]; P =0.01). Major bleeding rates were nonsignificantly different in the discordance versus concordance group (5.7% versus 2.7%; odds ratio, 2.2 [95% CI, 0.9–5.6]; P =0.09). Conclusions: The MDRD and CKD-EPI formulae suggest a different dosing in up to a quarter of anticoagulated patients with atrial fibrillation. This seems to impact hard outcomes.

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