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 <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.

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 Real-world clinical outcomes and anticoagulant therapy in elderly non-valvular atrial fibrillation patients with heart failure: sub-analysis of the ANAFIE Registry

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Ikeda ◽  
K Hiasa ◽  
H Tsutsui ◽  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Incidence Rate ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Real World ◽  
Reference Group ◽  
Incidence Rates ◽  
Female Ratio ◽  
All Cause Mortality

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are bidirectionally correlated; the more severe the NYHA classification, the higher the incidence rate of atrial fibrillation, and vice versa. HF is included in the items of CHA2DS2-VASc score used to calculate stroke risk in patients with AF, and is itself a risk factor for thromboembolism in such patients. Anticoagulant management in AF patients with HF is thus a key concern that remains to be sufficiently examined, especially in elderly patients aged ≥75 y. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry enrolled more than 30,000 elderly (≥75 y) patients with non-valvular AF (NVAF), aiming to produce real-world data on their clinical status and prognosis. This sub-analysis of the ANAFIE Registry assessed the 2-year outcomes and status of anticoagulant treatment in elderly NVAF patients with HF. Methods A total of 32,275 patients from the ANAFIE Registry were divided into two groups according to whether they had HF (HF group and reference group). The incidence rates and adjusted hazard ratios (HR) of clinical outcomes were determined using Kaplan-Meier analysis and the Cox proportional-hazards model, respectively. Results A total of 20,159 (62.5%) patients were included in the reference group, and 12,116 (37.5%) in the HF group. Compared with the reference group, the HF group had higher mean age (82.4 vs 80.9 y), female ratio (46.6% vs 40.4%), non-paroxysmal AF (69.8% vs 50.8%), and had lower mean CrCL (43.3 vs 51.6 mL/min). In the HF group, the rate control drugs were frequently used (50.1% vs 35.8%), and the rhythm control drugs were less used (14.2% vs 22.7%) than in the reference group. More patients in the HF group were using anticoagulants (93.9% vs 91.6%; warfarin (WF), 29.6% vs 23.0%; direct oral anticoagulants (DOAC), 64.2% vs 68.5%) than those in the reference group. The HF group had a numerically higher incidence of stroke or systemic embolic events (SEE) (3.28% vs 2.84%, HR 0.96, p=0.558) and major bleeding (2.35% vs 1.79%, HR 1.14, p=0.130) than the reference group, but the differences were not statistically significant. The HF group had a significantly higher incidence rate of HF requiring hospitalization (12.99% vs 4.59%, HR 1.94, p&lt;0.001) and all-cause mortality (9.83% vs 5.21%, HR 1.32, p&lt;0.001). In the HF group, patients receiving DOAC had significantly lower incidence rates for major bleeding, HF requiring hospitalization, and all-cause mortality than those receiving WF, while there was no difference for stroke/SEE between both groups. Conclusions Elderly NVAF patients with HF had higher risk of HF requiring hospitalization and mortality than those without. Differences were seen in the incidence rates of major bleeding, HF requiring hospitalization, and all-cause mortality between patients on DOAC and those on WF. This study will explore relevant factors affecting clinical outcomes in elderly NVAF patients with HF. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

scholarly journals Plasma natriuretic peptide level is an independent determinant of major clinical outcomes in atrial fibrillation patients without heart failure: the Fushimi AF Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Hamatani ◽  
M Iguchi ◽  
Y Aono ◽  
K Ishigami ◽  
S Ikeda ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Clinical Outcomes ◽  
Prognostic Marker ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
The Mean

Abstract Background Atrial fibrillation (AF) increases the risk of death, stroke/systemic embolism and heart failure (HF). Plasma natriuretic peptide (NP) level is an important prognostic marker in HF patients. However, little is known regarding the prognostic significance of plasma NP level in AF patients without HF. Purpose The aim of this study is to investigate the relationship between plasma NP level and clinical outcomes such as all-cause death, stroke/systemic embolism and HF hospitalization during follow-up period in AF patients without HF. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city. The inclusion criterion of the registry is the documentation of AF at 12-lead electrocardiogram or Holter monitoring at any time, and there are no exclusion criteria. We started to enroll patients from March 2011, and follow-up data were available for 4,466 patients by the end of November 2019. From the registry, we excluded 1,220 patients without a pre-existing HF (defined as having one of the following; prior hospitalization for HF, New York Heart Association class ≥2, or left ventricular ejection fraction &lt;40%). Among 3,246 AF patients without HF, we investigated 1,189 patients with the data of plasma BNP (n=401) or N-terminal pro-BNP (n=788) level at the enrollment. We divided the patients according to the quartile of each plasma BNP or NT-pro BNP level and compared the backgrounds and outcomes between these 4 groups stratified by plasma NP level. Results Of 1,189 patients, the mean age was 72.1±10.2 years, 454 (38%) were female and 684 (58%) were paroxysmal AF. The mean CHADS2 and CHA2DS2-VASc score were 1.6±1.1 and 2.9±1.5, respectively. Oral anticoagulants were prescribed in 671 (56%) at baseline. The median (interquartile range) BNP and N-terminal pro-BNP level were 84 (38, 176) and 500 (155, 984) pg/ml, respectively. Patients with high plasma NP level were older, and demonstrated lower prevalence of paroxysmal AF, higher CHADS2 and CHA2DS2-VASc scores and higher prevalence of chronic kidney disease and oral anticoagulants prescription (all P&lt;0.01). A total of 165 all-cause death, 114 stroke/systemic embolism and 103 HF hospitalization occurred during the median follow-up period of 5.0 years. Kaplan-Meier curves demonstrated that higher plasma NP level was significantly associated with the incidences of all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF (Figure 1A). Multivariable Cox regression analysis revealed that plasma NP level could stratify the risk of clinical outcomes even after adjustment by type of AF, CHA2DS2-VASc score, chronic kidney disease and oral anticoagulant prescription (Figure 1B). Conclusion Plasma NP level is a significant prognostic marker for all-cause death, stroke/systemic embolism and HF hospitalization in AF patients without HF, suggesting the importance of measuring plasma NP level in AF patients even without HF. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Impacts of off-label dosing noacs on clinical outcomes in very elderly patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
Very Elderly ◽  
Off Label ◽  
Funding Sources ◽  
Clinical Events

Abstract Background Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age. Methods We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing. Results Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2). Conclusions Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

scholarly journals Anticoagulation Challenges in Hematogeriatrics: Effectiveness and Safety of Direct Oral Anticoagulants Vs Vitamin k Antagonist in Elderly with Atrial Fibrillation

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1162-1162
Author(s):  
Desirée Campoy ◽  
Gonzalo Artaza ◽  
César A Velasquez ◽  
Tania Canals ◽  
Erik A Johansson ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Vitamin K ◽  
Major Bleeding ◽  
Frail Elderly ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Bleeding Events

BACKGROUND Direct oral anticoagulants (DOAC) are increasingly used in patients with Non Valvular Atrial Fibrillation (NVAF) for stroke prevention. However, Follow-Up (FU) and dosing these agents in the elderly can be challenging due to different factors, such as chronic kidney disease, frailty, falls, multifactorial anemia and concomitant polypharmacy. These factors in elderly patients predisposes to both thromboembolic and bleeding events once atrial fibrillation occurs. Therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. Despite recent increases in DOAC use in NVAF, there are still limited data regarding DOACs effectiveness and safety in frail elderly patients. AIM To assess the effectiveness and safety according to DOAC or Vitamin K Antagonist (VKA) in a cohort of elderly patients with NVAF. METHODS From April 2016 to April 2019, we consecutively included NVAF elderly patients (≥80 years-old) treated with DOAC or VKA in a prospective multicenter registry. Demographic, laboratory, frailty risk stratification and antithrombotic therapy data were collected. Patients had a minimum FU of 6 months. VKA patients had a standard FU through digital international normalized ratio (INR) control and the efficacy of therapy was determined by the time in therapeutic range (TTR) values from the preceding 6 months of treatment using Rosendaal's method. FU in DOAC patients was performed through structured and integral assessment following the Tromboc@t Working Group recommendations for management in patients receiving DOAC (Olivera et al, Med Clin 2018). Key practical management aspects are listed in the flow chart (Figure 1). Clinical Frailty Scale (CFS score) was assigned to each patient at the beginning and during the FU; patients were classified into three categories: non-frail (CFS 1-4), mild-to-moderately frail (CFS 5-6), and severely frail (CFS 7-9). RESULTS From a total of 1040 NVAF patients, 690 (63.5%) were treated with DOAC (61 dabigatran, 95 rivaroxaban, 254 edoxaban and 280 apixaban) and 350 with VKA. In the VKA group, the mean TTR was 52.8%. Demographic characteristics and CFS score are summarized in table 1. Kaplan-Meier analysis (median FU: 16.5 months) showed a significantly high incidence of stroke/systemic embolism among VKA patients vs DOAC patients (4.2 vs 0.5 events per 100 patient-years, p<0.001). Major bleeding in the DOAC group was significantly infrequent compared with VKA group (2.2 vs 8.9 events, p=0.001). In the DOAC group, 90% (n=20/22) of the major bleedings were gastrointestinal [16 rivaroxaban and 4 edoxaban]. However, in the VKA group 64% (n = 20/31) were gastrointestinal, 25.8% (n= 8/31) intracranial and 9.7% (n = 3/31) urogenital bleedings. We identified 365 very elderly patients (aged ≥ 90 years) of which 270 (39.1%) were DOAC patients and 95 (27.1%) VKA patients. In this subgroup of patients, after a multivariate regression analysis, the stroke/systemic embolism incidence was similar in both treatment groups regardless of the age, but major bleeding decreased significantly in DOAC group (adjusted HR 0.247, 95% CI 0.091-0.664). CONCLUSIONS Our data indicate that DOACs can be a good therapeutic option for stroke/systemic embolism prevention in frail elderly patients, showing low rates of stroke as well as bleeding events when a structured and integral FU is applied to anticoagulated patients. Further investigations are necessary to analyze the impact in the quality of life and net clinical benefit of anticoagulant therapy when a FU program is applied in elderly patients. Disclosures Sierra: Novartis: Honoraria, Research Funding, Speakers Bureau; Astellas: Honoraria; Pfizer: Honoraria; Daiichi-Sankyo: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Roche: Honoraria; Jazz Pharmaceuticals: Honoraria.

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.

Long-term clinical outcomes after major bleeding in patients with atrial fibrillation: the Fushimi AF registry

2020 ◽  
Author(s):  
Hisashi Ogawa ◽  
Yoshimori An ◽  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
Kosuke Doi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Community Based ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P &lt; 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P &lt; 0.01), history of major bleeding (7.7% vs. 4.0%; P &lt; 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P &lt; 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P &lt; 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)

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