Edoxaban treatment of elderly patients with atrial fibrillation in routine clinical practice: 1-year results of the non-interventional Global ETNA-AF program

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Yamashita ◽  
C.C Wang ◽  
Y.-H Kim ◽  
R De Caterina ◽  
P Kirchhof ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Major Bleeding ◽  
Intracranial Haemorrhage ◽  
Clinical Care ◽  
Oral Anticoagulants ◽  
Clinical Event ◽  
Funding Source ◽  
Private Company ◽  
All Cause Mortality

Abstract Background The prevalence of atrial fibrillation (AF) and the need for appropriate anticoagulation increase with age. The benefit/risk profile of direct oral anticoagulants such as edoxaban in elderly population with AF in regular clinical practice is therefore of particular interest. Purpose Analyses of Global ETNA-AF data were performed to report patient characteristics, edoxaban treatment, and 1-year clinical events by age subgroups. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program conducted in Europe, Japan, Korea, Taiwan, and other Asian countries. Demographics, baseline characteristics, and 1-year clinical event data were analysed in four age subgroups. Results Of 26,823 patients included in this analysis, 50.4% were ≥75 years old and 11.6% were ≥85 years. Increase in age was generally associated with lower body weight, lower creatinine clearance, higher CHA2DS2-VASc and HAS-BLED scores, and a higher percentage of patients receiving the reduced dose of 30 mg daily edoxaban. At 1-year, rates of ISTH major bleeding and ischaemic stroke were generally low across all age subgroups. The proportion of intracranial haemorrhage within major bleeding events was similar across age groups. All-cause mortality increased with age more than cardiovascular mortality. Conclusion Data from Global ETNA-AF support the safety and effectiveness of edoxaban in elderly AF patients (including ≥85 years) in routine clinical care with only a small increase in intracranial haemorrhage. The higher all-cause mortality with increasing age is not driven by cardiovascular causes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo

P4758Label adherence of non-vitamin K antagonist oral anticoagulants and clinical outcomes in patients with atrial fibrillation: A nationwide study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H T Yu ◽  
P S Yang ◽  
E Jang ◽  
T H Kim ◽  
J S Uhm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Clinical Outcomes ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Background Dose adjustment of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in some patients with atrial fibrillation (AF), based on selected patient factors or concomitant medications. Purpose We assessed the frequency of label adherence of NOAC dosing among AF patients and the associations between off-label NOAC dosing and clinical outcomes in real-world clinical practice. Methods We evaluated 53,649 AF patients treated with a NOAC using Korean National Health Insurance Service database during the period from January 2013 to December 2016. NOAC doses were classified as either underdosed or overdosed, consistent with U.S. Food and Drug Administration labeling. Cox proportional hazards regression was performed to investigate the effectiveness and safety outcomes including stroke or systemic embolism, major bleeding, and all-cause mortality. Results Overall, 16,757 NOAC-treated patients (31.2%) were underdosed, 4,492 were overdosed (8.4%), and 32,400 (60.4%) were dosed appropriately according to drug labeling. Compared with patients with label adherence, those who were underdosed or overdosed were older (71±8 and 75±7 years of age vs. 70±9 years of age, respectively; p<0.001), more likely female (39% and 53% vs. 38%, respectively; p<0.001), and had higher CHA2DS2-VASc scores (4.6±1.7 and 5.3±1.7 vs. 4.5±1.8, respectively; p<0.001). NOAC overdosing was associated with increased risk for stroke or systemic embolism (5.76 vs. 4.03 events/100 patient-years, p<0.001), major bleeding (4.77 vs. 2.94 events/100 patient-years, p<0.001), and all-cause mortality (5.43 vs. 3.05 events/100 patient-years, p<0.001) compared with label-adherent use. Figure 1 Conclusion In routine clinical practice, a significant proportion (almost 2 in 5) of AF patients received NOAC doses inconsistent with drug labeling. NOAC overdosing is associated with increased risk for stroke or systemic embolism, major bleeding, and all-cause mortality in Asian patient with AF.

scholarly journals Impact of polypharmacy on clinical outcomes in elderly patients with nonvalvular atrial fibrillation: sub-analysis of the ANAFIE Registry

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Yamashita ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Incidence Rates ◽  
Cox Proportional Hazards Model ◽  
Private Company ◽  
All Cause Mortality ◽  
The Mean

Abstract Background Elderly patients with AF often have multimorbidities leading to treated by polypharmacy, which has been reported to be associated with worse prognosis. Although stroke prevention is a cornerstone of optimal anticoagulation management, data on elderly NVAF patients aged ≥75 years with polypharmacy are lacking. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study that seeks to elucidate real-world data on the clinical status and prognosis of more than 30,000 Japanese patients (aged ≥75 y) with NVAF. This sub-analysis of the ANAFIE Registry assessed 2-year outcomes and the status of anticoagulant management in elderly NVAF patients in view of polypharmacy. Methods A total of 32,275 patients from the ANAFIE Registry were divided into 3 groups by the number of concomitant medicines other than oral anticoagulants (OAC) (0 to 4, 5 to 8, ≥9 medicines). The annualized incidence rates of clinical outcomes were determined by Kaplan-Meier analysis. Hazard ratios (HR) for clinical outcomes were determined using the Cox proportional-hazards model. Results In the overall population, the mean age was 81.5 y; men accounted for 57.3%; the mean CHA2DS2-VASc score was 4.5; the mean HAS-BLED score was 1.9; the prevalence of paroxysmal AF was 42.1%; the mean follow-up period was 1.88 y; oral anticoagulants (OAC) were used by 92.4% of patients (WF, 25.5%; DOAC, 66.9%); the major concomitant medicines were antihypertensive drugs (70.9%), antiarrhythmic drugs (56.2%), dyslipidemia drugs (37.1%), and proton pump inhibitors (36.6%). The numbers of patients using 0 to 4, 5 to 8, and ≥9 concomitant medicines were 12,186 (37.8%), 13,597 (42.1%), and 5,636 (17.5%), respectively. As the number of concomitant medicines increased, the prevalence of comorbidities and renal dysfunction of creatinine clearance &lt;50 mL/min increased. With an increase in concomitant medications, use of WF increased and that of DOAC decreased. Overall annualized incidence rates (% per patient-year) of clinical outcomes were 1.62 for stroke or systemic embolic events (SEE), 1.08 for major bleeding, 5.91 for cardiovascular (CV) events, 1.08 for CV death, and 3.71 for all-cause mortality. The annualized incidence rates and HR for each clinical outcome are shown in the table. As the number of concomitant medicines increased, the incidence for major bleeding, gastrointestinal bleeding, CV events, and all-cause death were significantly increased. Conclusions In elderly NVAF patients from the ANAFIE registry, polypharmacy was associated with increased risks of major bleeding, CV events, CV death, and all-cause mortality. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

scholarly journals Anticoagulant treatment status and outcomes of elderly non-valvular atrial fibrillation patients with a history of catheter ablation in Japan: subanalysis of the ANAFIE registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
K Okumura
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Major Bleeding ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Cox Proportional Hazards Model ◽  
Anticoagulant Treatment ◽  
Private Company ◽  
All Cause Mortality ◽  
History Of

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd. OnBehalf ANAFIE Registry Group Backgrounds Benefits of catheter ablation (CA) have been shown for patients with atrial fibrillation (AF). However, data in elderly patients aged ≥75 years who have undergone CA for non-valvular AF (NVAF) are insufficient. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study, which was designed to collect the real-world data on the clinical status and prognosis in 30,000 over Japanese patients (aged ≥75 years) with NVAF. This cross-sectional subanalysis of the ANAFIE registry assessed the 2-year outcomes and anticoagulant treatment in elderly NVAF patients with a history of CA. Methods A total of the 32,275 patients from the ANAFIE registry were divided into two groups by a history of CA: the CA and No-CA groups. Kaplan-Meier analysis was used to evaluate the annualized incidences of stroke/systemic embolic event (SEE), major bleeding, intracranial hemorrhage (ICH), heart failure requiring hospitalization (HF), and all-cause mortality. Hazard ratio (HR) for each event was analyzed using the Cox proportional-hazards model. Results Of all patients, 2,970 patients (9.2%) were included in the CA group and 29,305 (90.8%) were included in the No-CA group. The CA group had lower age (mean 78.9 vs 81.7 years), higher prevalence of paroxysmal AF (73.0 vs 39.0%), higher creatinine clearance (mean 53.1 vs 47.9 mL/min) and lower CHA2DS2-VASc (mean 4.2 vs 4.5) and HAS-BLED scores (mean 1.8 vs 1.9) than the No-CA group. Oral anticoagulants (OACs) were administered in 87.3% of the CA group (warfarin, 16.8%; direct OAC, 70.5%) and 92.9% of the No-CA group (warfarin, 26.4%; direct OAC, 66.5%). Compared with the No-CA group, the CA group had lower the annualized incidences (/100 patient-year [95%confidence intervals]) of stroke/SEE (0.74 [0.52, 0.96] vs 1.72 [1.61, 1.83]), major bleeding (0.63 [0.43, 0.84] vs 1.12 [1.03, 1.21]), ICH (0.49 [0.31, 0.67] vs 0.78 [0.71, 0.86]), HF (2.54 [2.12, 2.96] vs 4.44 [4.26, 4.62]), and all-cause mortality (1.45 [1.14, 1.77] vs 3.95 [3.78, 4.11]). Conclusions Elderly NVAF patients with a history of CA had lower adverse incidences compared with patients without a history of CA. A more optimal OAC therapy for elderly NVAF patients with a history of CA should be examined in the future.

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.

scholarly journals Non-vitamin K antagonist oral anticoagulants vs. vitamin-K antagonists in patients with atrial fibrillation and chronic kidney disease: a nationwide cohort study

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Emma Kirstine Laugesen ◽  
Laila Staerk ◽  
Nicholas Carlson ◽  
Anne-Lise Kamper ◽  
Jonas Bjerring Olesen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
All Cause Mortality ◽  
Comparable Population

Abstract Background We aimed to compare effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin-K antagonists (VKA) in atrial fibrillation (AF) patients with chronic kidney disease (CKD) not receiving dialysis. Methods By using personal identification numbers, we cross-linked individual-level data from Danish administrative registries. We identified every citizen with a prior diagnosis of AF and CKD who initiated NOAC or VKA (2011–2017). An external analysis of 727 AF patients with CKD (no dialysis) was performed to demonstrate level of kidney function in a comparable population. Study outcomes included incidents of stroke/thromboembolisms (TEs), major bleedings, myocardial infarctions (MIs), and all-cause mortality. We used Cox proportional hazards models to determine associations between oral anticoagulant treatment and outcomes. Results Of 1560 patients included, 1008 (64.6%) initiated VKA and 552 (35.4%) initiated NOAC. In a comparable population we found that 95.3% of the patients had an estimated glomerular filtration rate (eGFR) < 59 mL/min. Patients treated with NOAC had a significantly decreased risk of major bleeding (hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.26–0.84) compared to VKA. There was not found a significant association between type of anticoagulant and risk of stroke/TE (HR: 0.83, 95% CI: 0.39–1.78), MI (HR: 0.45, 95% CI: 0.18–1.11), or all-cause mortality (HR: 0.99, 95% CI: 0.77–1.26). Conclusion NOAC was associated with a lower risk of major bleeding in patients with AF and CKD compared to VKA. No difference was found in risk of stroke/TE, MI, and all-cause mortality.

P1257ETNA-AF Europe: First 1-year follow-up snapshot analysis of more than 7,500 AF patients treated with edoxaban in routine clinical practice

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
C De Asmundis ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Creatinine Clearance ◽  
Major Bleeding ◽  
Intracranial Haemorrhage ◽  
Patient Characteristics ◽  
Routine Clinical Practice ◽  
Comparable Efficacy ◽  
All Cause Mortality ◽  
First Occurrence

Abstract Introduction Edoxaban has been approved for stroke prevention in patients with atrial fibrillation based on its comparable efficacy and superior safety compared to warfarin in the pivotal ENGAGE AF-TIMI 48 trial. ETNA-AF Europe (NCT02944019) was initiated in agreement with the EMA to evaluate benefits and risks of edoxaban treatment in unselected patients in routine clinical practice. Methods 13,980 patients from across 825 hospital and office-based physicians from 10 European countries (Austria, Belgium, Germany, Ireland, Italy, The Netherlands, Portugal, Spain, Switzerland and United Kingdom) were enrolled, and will be followed-up for 4 years. This snapshot analysis includes baseline and first outcome data of 7,672 patients (56.3% of all enrolled patients) that have completed their first 1-year follow-up visit (mean follow-up: 343.5 days). Results The average age of patients was 73.4 years, the mean weight was 81.9 kg (Table 1). Frequent comorbidities include hypertension (77.2%), valvular heart disease (17.4%), congestive heart failure (5.8%) and history of myocardial infarction (4.2%). Patients receiving the 30 mg dose (22.9%) were older, had a lower creatinine clearance and had a higher risk for both stroke and bleeding as compared to those on the 60 mg dose (77.1%). Overall, the incidence of clinical events was low: all-cause mortality: 3.56%/y, major bleeding 0.95%/y, intracranial haemorrhage 0.28%/y, any stroke or systemic embolic events 0.88%/y. Patient characteristics at Year 1 Patient characteristics All patients Edoxaban 60 mg Edoxaban 30 mg [7,672] [5,916 (77.1%)] [1,756 (22.9%)] Age [years] mean (SD) 73.4 (9.26) 71.8 (8.98) 79.1 (7.81) Body weight [kg] mean (SD) 81.9 (17.33) 84.1 (16.80) 74.3 (16.93) CrCl (CG) [mL/min] mean (SD) 75.0 (30.29) 82.5 (29.14) 51.2 (19.75) CHA2DS2-VASc mean (SD) 3.1 (1.38) 2.9 (1.34) 3.8 (1.28) HAS-BLED mean (SD) 2.5 (1.10) 2.4 (1.07) 2.9 (1.08) First occurrence of all-cause mortality (n, %/year) 257 (3.56%) 129 (2.31%) 128 (7.90%) First occurrence of intracranial haemorrhage (n, %/year) 20 (0.28%) 16 (0.29%) 4 (0.25%) First occurrence of major bleeding (n, %/year) 68 (0.95%) 49 (0.88%) 19 (1.18%) First occurrence of stroke/SEE (n, %/year) 63 (0.88%) 45 (0.81%) 18 (1.11%) CG, Cockcroft-Gault; CrCl, creatinine clearance; SD, standard deviation; SEE, systemic embolic events. Conclusions We found low bleeding and stroke rates in 7,672 unselected, mainly elderly AF patients treated with edoxaban in routine clinical practice. These findings were consistent across edoxaban doses and reinforce the effectiveness and safety of NOACs such as edoxaban in routine clinical care in Europe. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany

Relationship between frailty and all-cause mortality in patients with atrial fibrillation: a report from the ESC-EHRA EURObservational research programme AF general long-term registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
M Vitolo ◽  
S Harrison ◽  
G.A Dan ◽  
A.P Maggioni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Frailty Index ◽  
Primary Study ◽  
Funding Source ◽  
Private Company ◽  
Kaplan Meier ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Introduction Frailty is a major health determinant for cardiovascular disease. Thus far, data on frailty in patients with atrial fibrillation (AF) are limited. Aims To evaluate frailty in a large contemporary cohort of European AF patients, the relationship with oral anticoagulant (OAC) prescription and with risk of all-cause death. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. A 38-items frailty index (FI) was derived from baseline characteristics according to the accumulation of deficits model proposed by Rockwood and Mitnitsky. All-cause mortality was the primary study outcome. Results Out of the 11096 AF enrolled patients, data for evaluating frailty were available for 6557 (59.1%) patients who have been included in this analysis (mean [SD] age 68.9 [11.5], 37.7% females). Baseline median [IQR] CHA2DS2-VASc and HAS-BLED were 3 [2–4] and 1 [1–2], respectively. At baseline, median [IQR] FI was 0.16 (0.12–0.23), with 1276 (19.5%) patients considered “not-frail” (FI&lt;0.10), 4033 (61.5%) considered “pre-frail” (FI 0.10–0.25) and 1248 (19.0%) considered “frail” (FI≥0.25). Age, female prevalence, CHA2DS2-VASc and HAS-BLED progressively increased across the FI classes (all p&lt;0.001). Use of OAC progressively increased among FI classes; after adjustments FI was not associated with OAC prescription (odds ratio [OR]: 1.09, 95% confidence interval [CI]: 0.98–1.19 for each 0.10 FI increase). Conversely, FI was directly associated with vitamin K antagonist (VKA) use (OR: 1.26, 95% CI: 1.18–1.34 for each 0.10 FI increase) and inversely associated with non-VKA OACs (NOACs) use (OR: 0.82, 95% CI: 0.77–0.88). FI was significantly correlated with CHA2DS2-VASc (Rho= 0.516, p&lt;0.001). Over a median [IQR] follow-up of 731 [704–749] days, there were 569 (8.7%) all-cause death events. Kaplan-Meier curves [Figure] showed an increasing cumulative risk for all-cause death according to FI categories. A Cox multivariable analysis, adjusted for age, sex, type of AF and use of OAC, found that increasing FI as a continuous variable was associated with an increased risk of all-cause death (hazard ratio [HR]: 1.56, 95% CI: 1.40–1.73 for each 0.10 FI increase). An association with all-cause death risk was found across the FI categories (HR: 1.71, 95% CI: 1.23–2.38 and HR: 2.88, 95% CI: 2.02–4.12, respectively for pre-frail and frail patients compared to non-frail ones). FI was also predictive of all-cause death (c-index: 0.660, 95% CI: 0.637–0.682; p&lt;0.001). Conclusions In a European contemporary cohort of AF patients the burden of frailty is significant, with almost 1 out of 5 patients found to be “frail”. Frailty influenced significantly the choice of OAC therapy and was associated with (and predictive of) all-cause death at follow-up. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP programme, several companies have supported it with unrestricted grants.

3054Efficacy and safety of non-vitamin K oral anticoagulants in patients with atrial fibrillation and cancer

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I Cavallari ◽  
G Verolino ◽  
G Patti
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Patients With Cancer ◽  
All Cause Mortality

Abstract Background Anticoagulation in patients with cancer and atrial fibrillation (AF) is particularly challenging given the higher risk of both thrombotic and bleeding complications in this setting. Data regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) in AF patients with malignancy remain unclear. Purpose In the present meta-analysis we further investigate the efficacy and safety of NOACs compared to warfarin in patients with AF and cancer assuming that available studies may be individually underpowered for endpoints at low incidence, i.e. stroke, major and intracranial bleeding. Methods We performed a systematic review and meta-analysis of studies comparing the use of NOACs vs. warfarin in AF patients with cancer. Efficacy outcome measures included stroke or systemic embolism, venous thromboembolism and mortality. Safety outcome measures were major bleeding and intracranial hemorrhage. Results We pooled data from 6 identified studies enrolling a total of 31,756 AF patients with cancer. Mean follow-up was 1.7 years. Patients with cancer had significantly increased annualized rates of venous thromboembolism (1.38% vs. 0.74%), major bleeding (9.01% vs. 5.13%), in particular major gastrointestinal bleeding (2.38% vs. 1.60%), and all-cause mortality (17.73% vs. 8.50%) vs. those without (all P values <0.001), whereas the incidence of stroke or systemic embolism and intracranial hemorrhage did not differ. Compared with warfarin, treatment with NOACs nominally decreased the risk of stroke or systemic embolism (5.41% vs. 2.70%; odds ratio, OR; 95% confidence intervals, CI 0.51, 0.26–1.01; P=0.05; Figure), mainly of ischemic stroke (OR 0.56; 95% CI 0.35–0.89; P=0.01), and the risk of venous thromboembolism (OR 0.51; 95% CI 0.42–0.61; P<0.001). In cancer patients receiving NOACs there was a significant reduction of major bleeding (3.95% vs. 4.66%; OR 0.66, 95% CI 0.46–0.94; P=0.02; Figure) and intracranial hemorrhage (0.26% vs. 0.66%; OR 0.25, 95% CI 0.08–0.82; P=0.02) vs. warfarin, with no difference in gastrointestinal major bleeding rates. Conclusion AF patients on oral anticoagulation and concomitant cancer are at higher risk of venous thromboembolism, major bleeding and all-cause mortality. NOACs may represent a safer and more effective alternative to warfarin also in this setting of patients.

P4785Clinical characteristics and 1-year outcomes in atrial fibrillation patients with or without history of intracranial haemorrhage treated with edoxaban: snapshot analysis of the Global ETNA-AF program

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P Kirchhof ◽  
M Unverdorben ◽  
Y Koretsune ◽  
C C Wang ◽  
Y H Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Intracranial Haemorrhage ◽  
Clinical Care ◽  
History Of ◽  
Baseline Characteristics ◽  
Stroke Death ◽  
Recurrent Haemorrhage

Abstract Background Patients with atrial fibrillation (AF) who survive an intracranial haemorrhage (ICH) are at high risk of stroke, death, and recurrent haemorrhage. Effectiveness and safety of the nonvitamin K antagonist oral anticoagulant (NOAC) edoxaban in this patient population has not been reported. Purpose This snapshot analysis from the global ETNA-AF program compared 1-year outcomes in AF patients with and without history of ICH treated with edoxaban from Europe, Japan, and Korea/Taiwan. Methods Global ETNA-AF (EU: NCT02944019, Japan: UMINehz745.116117011, Korea/Taiwan: NCT02951039) is a multinational, multicentre, prospective, noninterventional program of AF patients receiving edoxaban in regular clinical care. Demographics, baseline characteristics, and outcomes at 1-year follow-up were reported for 19416 patients with and without a history of ICH. Results Of the 19416 patients, 297 had a history of ICH. At 1-year follow-up, incidences of International Society on Thrombosis and Haemostasis (ISTH) major bleeding (including ICH) and clinically relevant nonmajor bleeding (CRNMB) were generally low. The rate of ischaemic stroke was higher in patients with a history of ICH than in those without prior ICH. Europe (N=7672) Korea/Taiwan (N=1701) Japan (N=10043) History of ICH, n (%) Yes No Yes No Yes No 36 (0.5) 636 (99.5) 27 (1.6) 1674 (98.4) 234 (2.3) 9809 (97.7) Age, median (IQR) 75 (69, 78) 74 (68, 80) 70 (66, 76) 72 (66, 77) 76 (71, 82) 75 (68, 81) Gender, male % 72.2 57.4 70.4 59.9 60.7 59.3 Weight, median (IQR) kg 80.0 (75.0, 88.0) 80.0 (70.0, 92.0) 68.0 (54.0, 77.0) 65.0 (58.0, 73.0) 57.0 (50.0, 65.0) 59.0 (51.0, 68.0) CHA2DS2-VASc, mean (SD) 4.2 (1.44) 3.1 (1.38) 3.9 (1.63) 3.0 (1.43) 4.0 (1.56) 3.4 (1.64) HAS-BLED, mean (SD) 4.3 (1.23) 2.6 (1.12) 3.9 (1.55) 2.4 (10.7) 3.7 (1.07) 2.3 (1.12) CrCl [mL/min], median (IQR) 70.5 (58.8, 85.1) 70.4 (53.8, 90.1) 63.7 (45.8, 84.2) 61.6 (48.4, 78.1) 58.5 (46.0, 73.2) 60.2 (46.1, 77.0) Edoxaban 60/30 mg, % 83.3 / 16.7 77.1 / 22.9 55.6 / 44.4 50.2 / 49.8 21.8 / 78.2 27.8 / 72.2 1-year outcome, n (%/year)   Major bleeding (ISTH) 2 (5.94) 66 (0.92) 0 (0) 13 (0.82) 3 (1.92) 66 (0.96)   Intracranial haemorrhage 1 (2.91) 19 (0.26) 0 (0) 5 (0.32) 1 (0.64) 18 (0.26)   Major GI* bleeding 0 (0.00) 20 (0.28) 0 (0) 2 (0.13) 2 (1.28) 30 (0.43)   CRNMB 0 (0.00) 102 (1.43) 0 (0) 11 (0.70) 6 (3.82) 219 (3.20)   Ischaemic stroke 1 (2.93) 41 (0.57) 1 (4.04) 11 (0.70) 4 (2.57) 78 (1.13) *Gastrointestinal. Conclusion Our data underpin the need for effective stroke prevention. In AF patients with a history of ICH, data suggest that edoxaban can be safely and effectively administered in patients with and without prior ICH in regular clinical care. Acknowledgement/Funding Daiichi Sankyo

scholarly journals Temporal trend of clinical events in patients with atrial fibrillation on edoxaban therapy: results from the non-interventional global ETNA-AF program

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Dinshaw ◽  
C Chen ◽  
R De Caterina ◽  
W Jiang ◽  
Y.-H Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Temporal Trend ◽  
Routine Clinical Practice ◽  
Clinical Event ◽  
Clinical Events ◽  
Baseline Characteristics

Abstract Background Patients with atrial fibrillation (AF) who initiated vitamin K antagonist (VKA) were at highest risk of stroke and bleeding in the first few months of therapy. Understanding of the temporal trend of clinical events in AF patients on non-VKA oral anticoagulant (NOAC) therapy should aid therapeutic decisions. Purpose To evaluate the temporal trend of clinical events in AF patients receiving edoxaban in routine clinical practice in the Global ETNA-AF program. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program evaluating the safety and effectiveness of edoxaban in patients from European and Asian countries. Thromboembolic, bleeding and death events were analysed separately for the 1st and 2nd year of the follow-up period, using a time-to-first-event estimation of cumulative incidence and annual rate via Kaplan-Meier method. Results A total of 27,617 patients were included in this analysis, 48.6% from Europe and 51.4% from Japan, Korea, and Taiwan. Baseline characteristics were consistent with typical AF population in real world studies (Table 1). Approximately 83% of patients received the recommended edoxaban dose. Annualized rates of ischaemic stroke and major bleeding (ISTH) were lower in the 2nd year than in the 1st year: ischaemic stroke 0.59% (95% CI, 0.50–0.70) vs 0.86% (95% CI, 0.75–0.98), p=0.015; major bleeding 0.87% (95% CI, 0.75–1.00) vs 1.15% (95% CI, 1.02–1.29), p=0.036. The trend toward lower rates of ischaemic stroke and major bleeding in the 2nd year was consistent across regions. All-cause mortality increased slightly from the 1st year to the 2nd year, which was not statistically significant and was not driven by cardiovascular (CV) mortality (Table 2). Conclusion In routine clinical practice in the Global ETNA-AF program, major bleeding and ischaemic stroke rates in &gt;27,000 patients on edoxaban therapy declined from 1st year to 2nd year. Further analyses will investigate whether such trend is influenced by selection for healthier patients over time. Longer follow-up is needed to better understand long-term trends. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Table 1. Baseline characteristics Table 2. Annualised clinical event rates

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