scholarly journals GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e033283 ◽  
Author(s):  
Frederik Dalgaard ◽  
Karen Pieper ◽  
Freek Verheugt ◽  
A John Camm ◽  
Keith AA Fox ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Risk Model ◽  
Oral Anticoagulants ◽  
External Validation ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Secondary Outcome

ObjectivesTo externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort.DesignRetrospective cohort study.SettingDanish nationwide registries.Participants90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year.Primary and secondary outcome measuresExternal validation was performed using discrimination and calibration plots. C-statistics were compared with CHA2DS2VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes.ResultsOf the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66–83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA2DS2VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60).ConclusionIn a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

P6258Direct oral anticoagulants in non-valvular atrial fibrillation: accuracy of traditional bleeding scores in the elderly

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Novello ◽  
A Graceffa ◽  
C Ninivaggi ◽  
G I Greco ◽  
F Bonfante ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Roc Curves ◽  
Bleeding Risk ◽  
Discriminatory Power ◽  
Risk Scores

Abstract Background Due to the fear of increased risk of bleeding, anticoagulation treatment is underutilized in the prevention of stroke in elderly patients with non-valvular atrial fibrillation (NVAF). Although direct oral anticoagulants (DOAC) are safer than VKA, still little is known about the risk factors associated with bleeding in elderly patients treated with DOAC. Furthermore, it is still uncertain whether the risk scores that are currently used can serve to effectively identify higher bleeding risk in elderly subjects. Purpose The aim of this study was to identify predictors of bleeding in a cohort of elderly people affected by NVAF treated with DOAC, and to evaluate the accuracy of risk scores for bleeding used at present. Methods Data on outpatients aged ≥75 years, naïve for DOAC therapy, who started therapy with Dabigatran, Rivaroxaban, Apixaban or Edoxaban for the prevention of thromboembolism during FANV were analyzed. HASBLED, ATRIA, OBRI and ORBIT scores were calculated for each patient. Patients had follow-up for 12 months during which deaths, therapy discontinuation and adverse events such as thromboembolism and bleeding were reported. Potential predictors of bleeding and the predictive value of each bleeding score were tested using univariate Cox regression; testing accuracy was evaluated using ROC curves. Results A total of 291 patients (52.9% female, mean age 82.85±5.18 years) had a median follow-up time of 11 (10–12) months. The incidence rate of major bleeding was 4.7 per 100 patient-years, the rate of intracranial bleeding was 0.4 per 100 patient-years. Patients who had major bleeding were more often affected by heart failure (63.6% vs 25%; p=0.009) and thrombocytopenia (36.4% vs 7.4%; p=0,009). However in the multivariate analysis only heart failure remained statistically associated with major bleeding (HR 3.83, 95% CI 1.06–13.85; p=0.041). None of tested bleeding risk scores was able to predict major bleeding in our cohort. HASBLED and ORBIT scores were able to predict major and non-major clinically relevant bleeding (HR 1.32; 95% CI 1.01–1.71; p=0.042 and HR 1.20; 95% CI 1.00- 1.43; p=0.046); only the ORBIT score was found to be statistically significant, but with weak discriminatory power at ROC curves (AUC 0.59; 95% CI 0.51–0.68; p=0.041). Conclusions In our cohort of elderly patients aged 75 or older, anticoagulated for NVAF, heart failure history was the only effective predictor of major bleeding risk during DOAC treatment. None of the bleeding risk scores used currently have demonstrated a good discriminatory power in our cohort. As predictive factors of bleedings in DOAC-treated patients may not be the same as those for VKA-treated patients and those in elderly may also be differ in younger people, it calls for more investigation on the topic.

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 Stroke prevention with non-vitamin K antagonist oral anticoagulants in high risk elderly atrial fibrillation patients at increased bleeding risk

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Vitamin K Antagonist ◽  
Full Dose ◽  
Reduced Dose

Abstract Background Elderly atrial fibrillation (AF) patients with risk factors of bleeding are often considered ineligible for standard oral anticoagulants (OACs). The ELDERCARE-AF trial recently showed that edoxaban 15mg/day was superior to placebo for preventing stroke or systemic embolism and did not result in a significantly higher incidence of major bleeding. Our aim was to investigate a real-world cohort of AF patients similar to the ELDERCARE-AF cohort, with regard to the impact of non-vitamin K antagonist oral anticoagulant (NOAC) use compared to non-OAC use, in relation to clinical outcomes. Methods From January 1, 2012 to December 31, 2016, 15,183 AF patients aged ≥80 years (mean age 86.63 years [SD 4.79]; 48.7% male) with a CHADS2 score &gt;2 who met the enrollment criteria (generally similar to ELDERCARE-AF) were identified from the Taiwan National Health Insurance Research Database. Patients were categorized into 2 groups according to their stroke prevention strategies, ie. without OACs (n=9,084) and NOACs (n=6,099). Patients receiving NOACs were further stratified into reduced-dose or full-dose regimen groups. Results Compared to the non-OAC group as a reference, NOAC use (whether as reduced dose or full dose) was associated with a lower risk of ischaemic stroke (adjusted hazard ratio [aHR] 0.766, 95% confidence interval [CI] 0.667–0.879) and all-cause mortality (aHR 0.393, 95% CI 0.370–0.418) while the risks of ICH and major bleeding were similar. The risks of composite outcomes of “ischaemic stroke or mortality” (aHR 0.423, 95% CI 0.398–0.449) and “ischaemic stroke or major bleeding or mortality” (aHR 0.490, 95% CI 0.463–0.518) were significantly lower with NOAC use. When compared to non-OAC as the reference groups, NOACs (whether reduced dose or full dose) showed a positive NCB. The results were generally consistent even after the propensity matching (Figure 1). Conclusions In routine clinical care, NOACs (whether reduced or full dose) were associated with a lower risk of ischemic stroke, mortality and the composite endpoint, when compared to non-OAC use in high risk elderly AF patients at increased bleeding risk. Our findings provide complimentary “real world” data to support the generalizability of the results of ELDERCARE-AF trial into daily clinical practice. FUNDunding Acknowledgement Type of funding sources: None. Figure 1

Reasons for and consequences of oral anticoagulant underuse in atrial fibrillation with heart failure

Heart ◽  
2018 ◽  
Vol 104 (13) ◽  
pp. 1093-1100 ◽  
Author(s):  
Gianluigi Savarese ◽  
Ulrik Sartipy ◽  
Leif Friberg ◽  
Ulf Dahlström ◽  
Lars H Lund
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Patients With Heart Failure ◽  
Unit Increase ◽  
History Of ◽  
Logistic Regressions

ObjectiveAtrial fibrillation (AF) is common in patients with heart failure (HF), and oral anticoagulants (OAC) are indicated. The aim was to assess prevalence of, predictors of and consequences of OAC non-use.MethodsWe included patients with AF, HF and no previous valve replacement from the Swedish Heart Failure Registry. High and low CHA2DS2-VASc and HAS-BLED scores were defined as above/below median. Multivariable logistic regressions were used to assess the associations between baseline characteristics and OAC use and between CHA2DS2-VASc and HAS-BLED scores and OAC use. Multivariable Cox regressions were used to assess associations between CHA2DS2-VASc and HAS-BLED scores, OAC use and two composite outcomes: all-cause death/stroke and all-cause death/major bleeding.ResultsOf 21 865 patients, only 12 659 (58%) received OAC. Selected predictors of OAC non-use were treatment with platelet inhibitors, less use of HF treatments, paroxysmal AF, history of bleeding, no previous stroke, planned follow-up in primary care, older age, living alone, lower income and variables associated with more severe HF. For each 1-unit increase in CHA2DS2-VASc and HAS-BLED, the ORs (95% CI) of OAC use were 1.24 (1.21–1.27) and 0.32 (0.30–0.33), and the HRs for death/stroke were 1.08 (1.06–1.10) and for death/major bleeding 1.18 (1.15–1.21), respectively. For high versus low CHA2DS2-VASc and HAS-BLED, the ORs of OAC use were 1.23 (1.15–1.32) and 0.20 (0.19–0.21), and the HRs for death/stroke were 1.25 (1.19–1.30) and for death/major bleeding 1.28 (1.21–1.34), respectively.ConclusionsPatients with AF and concomitant HF do not receive OAC on rational grounds. Bleeding risk inappropriately affects decision-making more than stroke risk.

Long-term bleeding risk prediction in ‘real world’ patients with atrial fibrillation: Comparison of the HAS-BLED and ABC-Bleeding risk scores

2017 ◽  
Vol 117 (10) ◽  
pp. 1848-1858 ◽  
Author(s):  
Vanessa Roldán ◽  
Vicente Vicente ◽  
Mariano Valdés ◽  
Gregory Y. H. Lip ◽  
María Asunción Esteve-Pastor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Bleeding Score ◽  
Better Than

SummaryRisk scores in patients with atrial fibrillation (AF) based on clinical factors alone generally have only modest predictive value for predicting high risk patients that sustain events. Biomarkers might be an attractive prognostic tool to improve bleeding risk prediction. The new ABCBleeding score performed better than HAS-BLED score in a clinical trial cohort but has not been externally validated. The aim of this study was to analyze the predictive performance of the ABC-Bleeding score compared to HAS-BLED score in an independent “real-world” anticoagulated AF patients with long-term follow-up. We enrolled 1,120 patients stable on vitamin K antagonist treatment. The HAS-BLED and ABC-Bleeding scores were quantified. Predictive values were compared by c-indexes, IDI, NRI, as well as decision curve analysis (DCA). Median HAS-BLED score was 2 (IQR 2–3) and median ABC-Bleeding was 16.5 (IQR 14.3–18.6). After 6.5 years of follow-up, 207 (2.84%/year) patients had major bleeding events, of which 65 (0.89%/year) had intracranial haemorrhage (ICH) and 85 (1.17%/year) had gastrointestinal bleeding events (GIB). The c-index of HAS-BLED was significantly higher than ABC-Bleeding for major bleeding (0.583 vs 0.518; p=0.025), GIB (0.596 vs 0.519; p=0.017) and for the composite of ICH-GIB (0.593 vs 0.527; p=0.030). NRI showed a significant negative reclassification for major bleeding and for the composite of ICH-GIB with the ABC-Bleeding score compared to HAS-BLED. Using DCAs, the use of HAS-BLED score gave an approximate net benefit of 4% over the ABC-Bleeding score. In conclusion, in the first “real-world” validation of the ABC-Bleeding score, HAS-BLED performed significantly better than the ABC-Bleeding score in predicting major bleeding, GIB and the composite of GIB and ICH.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.

Incident Risk Factors and Major Bleeding in Patients with Atrial Fibrillation Treated with Oral Anticoagulants: A Comparison of Baseline, Follow-up and Delta HAS-BLED Scores with an Approach Focused on Modifiable Bleeding Risk Factors

2018 ◽  
Vol 47 (04) ◽  
pp. 768-777 ◽  
Author(s):  
Tze-Fan Chao ◽  
Yenn-Jiang Lin ◽  
Shih-Lin Chang ◽  
Li-Wei Lo ◽  
Yu-Feng Hu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Modifiable Risk Factors ◽  
The Mean ◽  
Regular Review

Aim When assessing bleeding risk in patients with atrial fibrillation (AF), risk stratification is often based on the baseline risks. We aimed to investigate changes in bleeding risk factors and alterations in the HAS-BLED score in AF patients. We hypothesized that a follow-up HAS-BLED score and the ‘delta HAS-BLED score’ (reflecting the change in score between baseline and follow-up) would be more predictive of major bleeding, when compared with baseline HAS-BLED score. Methods and Results A total of 19,566 AF patients receiving warfarin and baseline HAS-BLED score ≤2 were studied. After a follow-up of 93,783 person-years, 3,032 major bleeds were observed. The accuracies of baseline, follow-up, and delta HAS-BLED scores as well as cumulative numbers of baseline modifiable bleeding risk factors, in predicting subsequent major bleeding, were analysed and compared. The mean baseline HAS-BLED score was 1.43 which increased to 2.45 with a mean ‘delta HAS-BLED score’ of 1.03. The HAS-BLED score remained unchanged in 38.2% of patients. Of those patients experiencing major bleeding, 76.6% had a ‘delta HAS-BLED’ score ≥1, compared with only 59.0% in patients without major bleeding (p < 0.001). For prediction of major bleeding, AUC was significantly higher for the follow-up HAS-BLED (0.63) or delta HAS-BLED (0.62) scores, compared with baseline HAS-BLED score (0.54). The number of baseline modifiable risk factors was non-significantly predictive of major bleeding (AUC = 0.49). Conclusion In this ‘real-world’ nationwide AF cohort, follow-up HAS-BLED or ‘delta HAS-BLED score’ was more predictive of major bleeding compared with baseline HAS-BLED or the simple determination of ‘modifiable bleeding risk factors’. Bleeding risk in AF is a dynamic process and use of the HAS-BLED score should be to ‘flag up’ patients potentially at risk for more regular review and follow-up, and to address the modifiable bleeding risk factors during follow-up visits.

Bleeding risks with frailty and multimorbidity in patients with atrial fibrillation. A nationwide analysis of 1.4 million subjects

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Fauchier ◽  
A Bisson ◽  
A Bodin ◽  
J Herbert ◽  
N Clementy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Major Bleeding ◽  
Frailty Index ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Frailty Phenotype ◽  
One Year

Abstract Background Frailty and multimorbidity are common in patients with atrial fibrillation (AF). The quantifiable frailty phenotype has been validated as predictive of mortality and disability, and patients can be categorised as frail and non-frail using the Claims-based Frailty Index (CFI). The Charlson comorbidity index (CCI) is a tool to quantify multimorbidity and also a strong estimator of mortality. We evaluated whether frailty and multimorbidity are associated with the risk of major bleeding in patients with AF. Methods Based on the administrative hospital-discharge database, we collected information for all patients with AF between 2010 and 2019 in France. CCI and CFI were calculated for each patient, and their associated risks of bleeding compared to 4 bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT). The analysis focused on patients with events or with at least one year of follow-up. Predictive abilities of the scores were compared in the whole population, and then separately in the subgroup of elderly patients (&gt;75 yo). Results Among 1,372,567 patients with AF, 131,535 major bleeding events were recorded during a follow-up of 3.5±2.1 years (median 3.1, IQR 1.8–4.9) (yearly rate 2.7%). Bleeding occurred more commonly in patients with higher HAS-BLED, ATRIA, CCI and CFI scores. Those with high frailty and multimorbidity had markedly higher yearly incidences of bleeding events of 13.0% and 14.7%, respectively (vs low frailty and multimorbidity: 4.3%% and 4.1%, respectively; p&lt;0.001). The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). In elderly patients (n=853,833), the c-statistics were all lower than in the whole population and were lower for the 4 scores than for the CCI and CFI scores (0.463, 0.473, 0.443, 0.445, 0.622 and 0.620 for HAS-BLED, ATRIA, ORBIT, HEMORR2HAGES, CCI and CFI, respectively). Conclusion Multimorbidity and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF. Funding Acknowledgement Type of funding source: None

scholarly journals The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e417-e426
Author(s):  
Carline J. van den Dries ◽  
Sander van Doorn ◽  
Patrick Souverein ◽  
Romin Pajouheshnia ◽  
Karel G.M. Moons ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Routine Care ◽  
P Value ◽  
Risk Of Mortality ◽  
Mortality Effect

Abstract Background The benefit of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) on major bleeding was less prominent among atrial fibrillation (AF) patients with polypharmacy in post-hoc randomized controlled trials analyses. Whether this phenomenon also exists in routine care is unknown. The aim of the study is to investigate whether the number of concomitant drugs prescribed modifies safety and effectiveness of DOACs compared with VKAs in AF patients treated in general practice. Study Design Adult, nonvalvular AF patients with a first DOAC or VKA prescription between January 2010 and July 2018 were included, using data from the United Kingdom Clinical Practice Research Datalink. Primary outcome was major bleeding, secondary outcomes included types of major bleeding, nonmajor bleeding, ischemic stroke, and all-cause mortality. Effect modification was assessed using Cox proportional hazard regression, stratified for the number of concomitant drugs into three strata (0–5, 6–8, ≥9 drugs), and by including the continuous variable in an interaction term with the exposure (DOAC vs. VKA). Results A total of 63,600 patients with 146,059 person-years of follow-up were analyzed (39,840 person-years of DOAC follow-up). The median age was 76 years in both groups, the median number of concomitant drugs prescribed was 7. Overall, the hazard of major bleeding was similar between VKA-users and DOAC-users (hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.87–1.11), though for apixaban a reduction in major bleeding was observed (HR 0.81; 95% CI 0.68–0.98). Risk of stroke was comparable, while risk of nonmajor bleeding was lower in DOAC users compared with VKA users (HR 0.92; 95% CI 0.88–0.97). We did not observe any evidence for an impact of polypharmacy on the relative risk of major bleeding between VKA and DOAC across our predefined three strata of concomitant drug use (p-value for interaction = 0.65). For mortality, however, risk of mortality was highest among DOAC users, increasing with polypharmacy and independent of the type of DOAC prescribed (p-value for interaction <0.01). Conclusion In this large observational, population-wide study of AF patients, risk of bleeding, and ischemic stroke were comparable between DOACs and VKAs, irrespective of the number of concomitant drugs prescribed. In AF patients with increasing polypharmacy, our data appeared to suggest an unexplained yet increased risk of mortality in DOAC-treated patients, compared with VKA recipients.

Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Benjamin A Steinberg ◽  
DaJuanicia N Simon ◽  
Laine Thomas ◽  
Jack Ansell ◽  
Gregg C Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Recurrent Bleeding ◽  
Bleeding Events ◽  
Reversal Agents ◽  
Major Bleeding Events

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.

Abstract P146: Comparative Effectiveness Of Direct Oral Anticoagulants Versus Warfarin Among Medicare Beneficiaries With Atrial Fibrillation

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Shirin Ardeshirrouhanifard ◽  
Huijun An ◽  
Ravi Goyal ◽  
Mukaila Raji ◽  
Caleb Alexander ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Cancer Patients ◽  
Risk Model ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Competing Risk ◽  
Secondary Outcome ◽  
Systemic Embolism ◽  
Competing Risk Model

Objective: Post-hoc analysis of three pivotal clinical trials suggests no difference in risk of ischemic stroke or systemic embolism among cancer patients with atrial fibrillation treated with direct oral anticoagulants (DOACs) vs. warfarin. However, these studies were underpowered and also do not reflect the context of real-world use. We compared the effectiveness of DOACs versus warfarin for the risk of stroke or systemic embolism and all-cause death in patients with NVAF. Methods: We used Surveillance, Epidemiology, and End Results (SEER)-Medicare data from 2009 to 2016 and included patients aged ≥66 years diagnosed with cancer (breast, bladder, colorectal, esophagus, lung, ovary, kidney, pancreas, prostate, stomach or uterus) and NVAF. We limited the cohort to patients who newly initiated warfarin or DOACs (from 2010 to 2016) with no history of ischemic stroke or systemic embolism. The primary outcome was hospitalization due to ischemic stroke or systemic embolism and the secondary outcome was all-cause death. We used Fine and Gray’s competing risk model, while treating death as a competing risk, to determine the association of oral anticoagulants with the incidence of stroke or systemic embolism. We also adjusted the analysis using inverse probability of treatment weighted (IPTW). Additionally, an IPTW-adjusted Cox proportional hazards regression model was constructed for all-cause death. Results: Of 1,028,784 patients with cancer, 158,744 (15.4%) were diagnosed with atrial fibrillation. After applying all inclusion criteria, the final study cohort included 7,334 cancer patients diagnosed with incident NVAF who newly initiated warfarin or DOACs, of which 3,194 (43.6%) used warfarin and 4,140 (56.4%) used DOACs. The unadjusted rate of stroke or systemic embolism was similar among warfarin and DOACs users (1.20 vs. 1.32 cases per 100 person-years, p=0.27). In the IPTW weighted competing risk model, the use of DOACs was not associated with an increased risk of stroke or systemic embolism compared with warfarin users (Hazard Ratio [HR] 1.41, 95% confidence intervals [CI] 0.90-2.20). However, DOACs users had a significantly lower risk of all-cause death compared with warfarin users (HR 0.82, CI 0.74-0.91). Conclusion: Among cancer patients diagnosed with NVAF, DOACs had a similar risk for stroke or systemic embolism compared to warfarin, although DOAC use was associated with reduced risk of all-cause mortality.

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