scholarly journals Time at home among nonvalvular atrial fibrillation patients treated with non-vitamin K antagonist oral anticoagulants versus warfarin

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Deitelzweig ◽  
A Keshishian ◽  
A Kang ◽  
A Jenkins ◽  
N Atreja ◽  
...  

Abstract Background Clinical trials and real-world database studies have shown the benefits of non-vitamin K antagonist oral anticoagulants (NOACs) compared to warfarin; however, measures of functional outcomes are critical in evaluating a patient's quality of life. Previous measures of time spent out of hospital in a home setting and time spent receiving disease-related care among non-valvular atrial fibrillation (NVAF) patients are lacking in the current literature. Purpose This analysis was based on the previously published ARISTOPHANES study, and used multiple data sources to evaluate the amount of time spent at a patient's home among NVAF patients who were prescribed NOACs versus warfarin. Methods This retrospective observational study used US data from CMS Medicare and four commercial databases to select adult NVAF patients who initiated apixaban, dabigatran, rivaroxaban, or warfarin (01JAN2013–30SEP2015). Time at home and time at home without external AF-related care were measured during the 180 days after the index date (OAC prescription). Time at home was defined as days from index date without any of the following: an inpatient, skilled nursing facility or nursing facility, hospice, or inpatient rehabilitation facility admission. Time at home and without external AF-related care was defined as days away from home and days with a claim for bleeding, stroke/systemic embolism, AF, or an INR test. Each day a claim was observed was counted as one day. In each database, three 1:1 NOAC-warfarin propensity-score-matched (PSM) cohorts were created before pooling the results. After PSM, a subgroup of patients who were alive and had ≥180 days of follow-up was created. Poisson regression was conducted in each NOAC-warfarin matched cohort to compare time at home and time at home without external AF-related care. Results After matching, a total of 100,977 apixaban-warfarin, 36,990 dabigatran-warfarin, and 125,068 rivaroxaban-warfarin patient pairs were selected. Of those patients, 38–46% had 180 days of follow-up available. Across treatment cohorts, approximately 75% of patients were at home for the 180-day follow-up. Apixaban, dabigatran, and rivaroxaban patients had 1.3, 0.9, and 0.8 more days at home, respectively, compared to warfarin patients. Patients treated with apixaban had 13.4 more days at home without AF-related care compared to warfarin, while dabigatran and rivaroxaban had 11.6 and 11.7 more days at home without AF-related care compared to warfarin. A greater proportion of warfarin patients than NOAC patients had an INR test (81–82% vs 14–21%), and days with INR testing were the main driver for external AF-related care for warfarin patients. Conclusion Among NVAF patients treated with OACs, NOACs were associated with a longer time at home and time at home without external AF-related care compared to warfarin. These results can help inform healthcare providers and patients regarding the impact of NOAC treatment in NVAF patients. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bristol-Myers Squibb Company and Pfizer Inc.

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Deitelzweig ◽  
A Keshishian ◽  
A Kang ◽  
A Jenkins ◽  
N Atreja ◽  
...  

Abstract Background Patient-centered outcomes, such as home time, are becoming increasingly important quality-of-life measures. There are limited data on the impact of oral anticoagulants (OACs) on home time among patients with non-valvular atrial fibrillation. Purpose This analysis, based on the previously published ARISTOPHANES study, used five US insurance claims databases (CMS Medicare and four commercial databases) to compare home time among NVAF patients who were prescribed non-vitamin K antagonist OACs (NOACs). Methods Adult NVAF patients who were newly prescribed apixaban, dabigatran, or rivaroxaban (01JAN2013–30SEP2015) were selected. Time at home was calculated as the number of days from the index date (NOAC prescription) without any of the following: an inpatient, skilled nursing facility (SNF) or nursing facility, hospice, or inpatient rehabilitation facility admission. Time at home and without external AF-related care was defined as days from index date without any events from the home time endpoint or any days with a claim for bleeding, stroke/systemic embolism (S/SE), AF, or an INR test. Time at home and without external AF-related care were measured during the 180 days of follow-up; patients were required to have been alive and have 180 days of follow-up post index. In each database, three 1:1 NOAC-NOAC propensity-score-matched (PSM) cohorts were created before combining the databases. For each NOAC-NOAC matched cohort, Poisson regression was conducted to compare time at home and time at home without external AF-related care. Results After PSM, 37,314 apixaban-dabigatran, 107,236 apixaban-rivaroxaban, and 37,693 rivaroxaban-dabigatran patient pairs were created of which 37–44% had 180 days of follow-up available. Across the NOAC cohorts, approximately 21–25% of patients had an admission to a hospital, SNF, nursing facility, rehabilitation center, or hospice during the 180-day follow-up. The time at home was generally consistent between the NOAC cohorts (177 days); however, apixaban patients had 0.5 more days at home compared to rivaroxaban patients. Across all NOAC cohorts, 7–8% had a claim for a S/SE, 11–15% had a claim for bleeding, and 15–22% had an INR test, while 87–89% of all patients had an AF-claim during the 180-day follow-up. Patients prescribed apixaban had 1 more day at home without external AF-related care compared to dabigatran, and 1.5 more days at home without external AF-related care compared to rivaroxaban. Dabigatran had <1 more day at home without external AF-related care compared to rivaroxaban. Conclusion Among NVAF patients treated with NOACs, there were small differences in the time at home and time at home without external AF-related care during the first 6 months of NOAC treatment. As NVAF is a chronic condition, it is important to understand the impact of NOAC treatment on these patient-centered outcomes. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bristol-Myers Squibb Company and Pfizer Inc.


Kardiologiia ◽  
2019 ◽  
Vol 59 (5) ◽  
pp. 68-79
Author(s):  
L. V. Popova ◽  
T. B. Kondratieva ◽  
M. B. Aksenova ◽  
T. V. Khlevchuk ◽  
M. Z. Kanevskaya

Non-vitamin K antagonist oral anticoagulants (NOACs) – direct oral anticoagulants – are getting the ever-broadening use in clinical practice. However, many problems related to optimal use of NOACs in specific clinical situations remain unresolved. European Heart Rhythm Association in April 2018 issued the renovated recommendations on the use of NOACs in patients with atrial fibrillation. The authors of recommendations presented some specific clinical variants for which they formulated practical advices based on the evidence obtained in randomized clinical trials. They also outlined the indications for use of NOACs, formulated practical start-program and scheme of subsequent follow-up management of patients taking NOACs. Recommendations contain information on pharmacokinetics of NOACs and their interactions with other drugs, consideration of feasibility of NOACs use in patients with chronic renal insufficiency or advanced liver disease. Many other practical problems are covered as well.  


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Siwaporn Deeprom ◽  
Thanit Chirananthavat

Abstract Background and Aims Lifelong oral anticoagulation (either with warfarin or a non–vitamin K antagonist oral anticoagulant (NOACs)) is indicated for stroke prevention in most patients with atrial fibrillation (AF). NOACs has been recommended for thromboembolism prophylaxis of nonvalvular AF. However, studies on the impact of NOACs on renal outcomes has been inconclusive. Method This retrospective cohort study compared 3 NOACs: apixaban, dabigatran and rivaroxaban to warfarin for their effects on renal outcomes in patients with nonvalvular AF who had been using these medications for at least 2 years as of 2017-2018. The primary outcome was either the incidence of > 30% decline in estimated glomerular filtration rate (eGFR) or doubling of the serum creatinine levels compare to baseline values at 24 months, and the secondary outcome was the incident of primary outcomes in different baseline eGFR subgroups (> 60 vs < 60 ml/min/1.73 m2) and major bleeding as an adverse event. Results 90 patients were enrolled in each group, totaling to 360 patients. The incidence of > 30% decline in eGFR is significantly higher in rivaroxaban compared to warfarin (hazard ratio: 2.09; 95% confidence interval: 1.35 to 3.24; p = 0.001). After multivariate analysis (using age, stage of chronic kidney disease, eGFR, CHAD2VAS and HASBLED score), dabigatran was also shown to significantly increase the incidence of > 30% decline in eGFR. In subgroup analysis, rivaroxaban resulted in higher incidence of > 30% decline in eGFR, in eGFR < 60 ml/min/1.73 m2 subgroup and higher incidence of doubling of the serum creatinine level in eGFR > 60 ml/min/1.73 m2 subgroup. There was no occurrence of major bleeding. Conclusion NOACs, especially rivaroxaban, may increase adverse renal outcomes in patients with nonvalvular AF.


BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031342 ◽  
Author(s):  
Ana Ruigómez ◽  
Pareen Vora ◽  
Yanina Balabanova ◽  
Gunnar Brobert ◽  
Luke Roberts ◽  
...  

ObjectiveTo determine discontinuation rates, patterns of use and predictors of discontinuation of non-vitamin K antagonist oral anticoagulants (NOACs) among patients with non-valvular atrial fibrillation (NVAF) in the first year of therapy.DesignPopulation-based cohort study.SettingUK primary care.Population11 481 patients with NVAF and a first prescription (index date) for apixaban, dabigatran or rivaroxaban (January 2012 to December 2016) with at least 1 year of follow-up and at least one further NOAC prescription in the year following the index date were identified. 1 year rates and patterns of discontinuation were described.Primary and secondary outcome measuresOutcome measures were the percentage of patients who, in the first year from starting NOAC therapy, discontinued with their oral anticoagulant (OAC) therapy (discontinuation was defined as a gap in OAC therapy of >30 days); switched OAC within 30 days; discontinued and reinitiated OAC therapy. Predictors of discontinuation were also evaluated.Results1 year discontinuation rates according to the index NOAC were 26.1% for apixaban, 40.0% for dabigatran and 29.6% for rivaroxaban. Reinitiation rates were 18.1% for apixaban, 21.7% for dabigatran and 17.3% for rivaroxaban, and switching rates were 2.8% for apixaban, 8.8% for dabigatran and 4.9% for rivaroxaban. More than 93% of reinitiations were with the index NOAC. Patients starting on dabigatran were more likely to switch OAC therapy than those starting on apixaban; ORs 4.28 (95% CI 3.24 to 5.65) for dabigatran and 1.89 (95% CI 1.49 to 2.39) for rivaroxaban. Severely reduced renal function was a predictor of any discontinuation, OR 1.77 (95% CI 1.28 to 2.44).ConclusionWhile the majority of patients with NVAF in the UK initiating NOAC treatment received continuous therapy in the first year of treatment, a substantial proportion of patients experienced gaps in treatment leaving them less protected against thromboembolism during these periods.


2020 ◽  
Vol 22 (Supplement_I) ◽  
pp. I22-I31
Author(s):  
Andreas Goette ◽  
Pascal Vranckx

Abstract About 20% of all atrial fibrillation (AF) patients develop coronary artery disease, which requires coronary stenting [percutaneous coronary intervention (PCI)]. Thus, this subcohort of AF patients may require aggressive antithrombotic therapy encompassing vitamin K antagonist (VKA) or non-vitamin K antagonist oral anticoagulants (NOAC) plus aspirin and a P2Y12 inhibitor. At present, four clinical Phase IIIb trials using dabigatran, rivaroxaban, apixaban, or edoxaban, were published. These studies assessed the impact of NOACs as a part of DAT therapy vs. triple therapy. Compared with triple therapy, NOAC-based DAT has been shown to be associated with reduced major bleeding as well as intracranial haemorrhages. The benefit, however, is somewhat counterbalanced by a higher risk of stent-related ischaemia during the early phase of dual therapy. Thus, triple therapy after stenting is appropriate for at least 14 days with a maximum of 30 days. Thereafter, DAT including a NOAC is the therapy of choice in AF PCI patients to reduce the risk of bleeding during a 1 year of follow-up compared to VKA-based regimes. The present review summarizes the published study results and demonstrates differences in trial design and reported outcomes.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G.Y.H Lip ◽  
A Keshishian ◽  
A Kang ◽  
X Luo ◽  
N Atreja ◽  
...  

Abstract Background Among non-valvular atrial fibrillation (NVAF) patients with a history of bleeding, there is a reluctance to use oral anticoagulants (OACs) due to concerns about the risk of bleeding associated with OACs. However, lack of OAC treatments for NVAF patients is associated with a higher risk of stroke and mortality. Non-vitamin K antagonist OAC (NOACs) have been approved for the prevention of stroke in NVAF patients. There are limited data comparing the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) between patients prescribed NOACs and with a history of bleeding. Purpose This study used multiple United States data sources to evaluate the risk of S/SE and MB among NVAF patients with prior bleeding events who were prescribed NOACs. Methods This retrospective observational study used data from CMS Medicare and four commercial databases–covering >180 million beneficiaries. The study selected adult NVAF patients who were prescribed apixaban, dabigatran, or rivaroxaban (01JAN2013–30JUN2019) and had a prior bleeding event which was defined as a hospitalization with a bleeding diagnosis (intracranial hemorrhage [ICH], gastrointestinal [GI] bleeding, or other bleeding sites) prior to or during the index treatment episode. After 1:1 propensity-score-matched (PSM) in each database between NOACs (apixaban-dabigatran, apixaban-rivaroxaban, and dabigatran-rivaroxaban), the resulting patient records were pooled. S/SE and MB (identified by inpatient claims) were captured during the follow-up period, which was defined as the time between the day after the index treatment date and treatment discontinuation or switch, death, end of study period, or end of medical and pharmacy enrollment. Hazard ratios of S/SE and MB were calculated using Cox proportional hazards models. Results Of the overall NVAF population treated with NOACs, 6.2% had a prior bleeding event (ICH: 13.5%; GI: 61.8%; Other: 24.6%). After PSM, a total of 11,106 apixaban-dabigatran, 30,665 apixaban-rivaroxaban, and 11,148 dabigatran-rivaroxaban pairs were matched. Apixaban was associated with a lower risk of S/SE compared to dabigatran and rivaroxaban, and dabigatran was associated with a similar risk of S/SE compared to rivaroxaban. Apixaban was associated with a lower risk of MB compared to dabigatran and rivaroxaban, and dabigatran was associated with a lower risk of MB compared to rivaroxaban (Figure). Conclusions In this subgroup of NVAF patients with a history of bleeding, apixaban was associated with a lower risk of S/SE and MB compared to dabigatran and rivaroxaban. Dabigatran was associated with a lower risk of MB compared to rivaroxaban. These results are informative for understanding the impact of NOAC treatment in NVAF patients with prior bleeding events. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bristol-Myers Squibb Company and Pfizer, Inc.


Cardiology ◽  
2020 ◽  
Vol 145 (10) ◽  
pp. 676-681
Author(s):  
Alexandru Gabriel Bejinariu ◽  
Hisaki Makimoto ◽  
Reza Wakili ◽  
Shibu Mathew ◽  
Jedrzej Kosiuk ◽  
...  

Introduction: Periprocedural oral anticoagulation (OAC) strategies for atrial fibrillation (AF) ablation procedures are changing rapidly. Objective: To assess the management and course of periprocedural OAC for AF ablation procedures in experienced electrophysiology (EP) centers in Germany over the last 12 months. Methods: The data are based on an electronic questionnaire, which was sent to 35 experienced EP centers in September 2018 and then exactly 1 year later. Participants provided information on their periprocedural OAC management, the handling with dual therapy (OAC plus single antiplatelet therapy), the availability of specific antidotes, the transseptal puncture approach, and noteworthy complications. Results: Responses were received from all 35 centers and represent 10,010 AF ablation procedures annually. In 2018, the administration of vitamin K antagonist (VKA) was continued throughout the procedure at all centers (100%). In contrast, the majority of centers used minimally interrupted periprocedural non-vitamin K antagonist oral anticoagulants (NOAC) (54.3%), 13 centers (37.2%) completely interrupted NOAC, and only 3 centers (8.5%) continued NOAC throughout the procedure. At the 1-year follow-up survey, 32 centers were found to have continued their previous strategy of periprocedural OAC and 3 changed from a minimally interrupted to a continued NOAC strategy. Of note, 30 centers (85.7%) performed transseptal puncture fluoroscopically without additional cardiac imaging. In the setting of uninterrupted periprocedural OAC management, no relevant complications were noted. Conclusion: Our survey shows marked heterogeneous periprocedural OAC management at experienced EP centers in Germany. Whereas continuation of VKA has already been integrated into clinical practice, the majority of centers still use a minimally interrupted NOAC strategy.


2018 ◽  
Vol 79 (1-2) ◽  
pp. 108-112
Author(s):  
José Beato-Coelho ◽  
João Pedro Marto ◽  
José Nuno Alves ◽  
Cláudia Marques-Matos ◽  
Sofia Calado ◽  
...  

Introduction: Clinical trials and subsequent meta-analyses showed advantages of non-vitamin K antagonists oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation. The impact of preadmission anticoagulation in acute ischaemic stroke (AIS) has not been established. Objective: To compare functional outcome of patients with AIS with preadmission NOACs vs. VKAs. Methods: A retrospective analysis was conducted on consecutive AIS patients under oral anticoagulation (VKAs or NOACs) admitted in 4 Portuguese hospitals within a period of 30 months. Two primary outcomes were defined and compared between VKA and NOAC groups: symptomatic intracerebral hemorrhage transformation (sICH) and modified Rankin Scale (mRS) at 3 months. Results: Four hundred sixty-nine patients were included, of whom 332 (70.8%) were treated with VKA and 137 (29.2%) with NOAC. Patients’ median age was 78.0 and 234 (49.9%) were male. NOAC-treated patients had a higher median CHA2DS2-VASc score than those under VKA (5.0 vs. 4.0, p = 0.023). The two primary outcomes showed no statistical differences between the VKAs’ group and the NOACs’ group (sICH: 5.4 vs. 5.4% [p = 0.911]; mRS at 3 months: 3.0 vs. 3.0 [p = 0.646], respectively). Conclusion: Preadmission anticoagulation with NOACs in AIS has a functional impact similar to that of VKAs.


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