Abstract 18465: Real World Comparison of Major Bleeding Risk Among Non-valvular Atrial Fibrillation Patients Newly Initiated on Warfarin versus Apixaban 5mg BID, Dabigatran 150 mg BID, or Rivaroxaban 20 mg QD

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Shital Kamble ◽  
Xianying Pan ◽  
Hemant Phatak ◽  
Hugh Kawabata ◽  
Cristina Masseria ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
Cox Proportional Hazards Model ◽  
Charlson Comorbidity Index Score ◽  
The Real

Aim: Limited data are available on the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs). The study purpose was to compare the first major bleeding event risk among non valvular atrial fibrillation patients (NVAF) patients newly initiated on dose-adjusted warfarin versus apixaban 5mg BID, dabigatran 150mg BID, or rivaroxaban 20 mg QD. Methods: Retrospective cohort study was conducted using MarketScan® commercial & Medicare supplemental database from 01/2012 to 12/2013. NVAF patients 18+ years with ≥1 year baseline and newly prescribed oral anticoagulant from 01/01/2013 to 12/31/2013 were included. Major bleeding was defined as bleeding requiring hospitalization on the index drug during the supply duration or within 30 days after the last supply day of the last prescription. A Cox proportional hazards model was used to estimate the hazard ratios (HR) of major bleeding adjusted for age, sex, baseline comorbidities and comedications. Results: Among 26,604 patients, 2,057 (7.73%) were newly initiated on apixaban 5mg, 3,768 (14.16%) on dabigatran 150mg, 8,066 (30.32%) on rivaroxaban 20mg and 12,713 (47.79%) on warfarin. Patients initiating warfarin (72.5±11.9 yrs) and apixaban 5mg (67.0±11.4 yrs) were older as compared to rivaroxaban 20mg (65.2±11.4 yrs) and dabigatran 150mg (65.4±11.5 yrs). Patients initiating warfarin had higher CHA 2 DS 2- VASc score (3.22±1.65) and Charlson comorbidity index score (2.37±2.33) (P <0.0001 across all treatments) as compared to those initiating NOACs. After adjusting for baseline characteristics, patients newly initiated on apixaban 5mg BID had significantly lower risk of major bleeding (HR: 0.53, 95% CI: 0.29-0.97, P=0.0399) as compared to those initiated on warfarin (Table). Conclusion: Among newly anticoagulated NVAF patients in the real world setting, as compared to dose adjusted warfarin, only patients initiating on apixaban 5mg BID were associated with significantly lower risk of major bleeding.

Abstract 16398: Comparison of Major Bleeding Risk and Associated Costs Among Newly Anticoagulated Non-valvular Atrial Fibrillation Patients

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Steven Deitelzweig ◽  
Amanda Bruno ◽  
Natalie Tate ◽  
Augustina Ogbonnaya ◽  
Manan Shah ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model

Real-world evidence highlighting the risks and benefits of novel oral anticoagulants (NOCAs) is lacking. This study compared major and clinically relevant non-major (CRNM) bleeding risk and costs among non-valvular atrial fibrillation (NVAF) patients newly treated with apixaban, dabigatran, rivaroxaban, or warfarin. A retrospective analysis of NVAF patients newly treated with apixaban, dabigatran, rivaroxaban, or warfarin was conducted using PharMetrics Plus data from 1/ 2012 - 9/ 2014. Patients were indexed on the date of the first anticoagulant prescription, and were required to be ≥18 years old and have CHA 2 DS 2 -VASc score > 0 and ≥ 1 month of follow-up. Patients were followed until discontinuation (≥30-day gap in treatment), treatment switch, end of continuous enrollment, 1 year post-index, or end of study. Major and CRNM bleeding, and bleeding-related costs were measured. Cox proportional hazards model was used to examine the association between anticoagulants and risk of bleeding and GLM was used to evaluate bleeding-related costs. The study included 24,573 NVAF patients; distributed as apixaban 11.7%, dabigatran 12.0%, rivaroxaban 36.7%, and warfarin 39.6%. Mean age was 64.4 and 66.5% were males. HAS-BLED and CHA 2 DS 2 -VASc scores averaged 2.0 and 2.7, respectively. After adjusting for differences in baseline characteristics, when compared to apixaban patients, rivaroxaban (HR: 1.5; P =0.0013) and warfarin (HR: 1.7; P <0.0001) patients were more likely to have major bleeding, and dabigatran (HR: 1.3; P =0.0030), rivaroxaban (HR: 1.7; P <0.0001), and warfarin (HR: 1.4; P <0.0001) patients were more likely to have CRNM bleeding. Major bleeding risk was similar between apixaban and dabigatran patients. Major and CRNM bleeding costs, when compared to apixaban patients ($154 and $18), were significantly higher for dabigatran ($457; P <0.0001 and $39; P <0.0001), rivaroxaban ($420; P <0.0001 and $61; P <0.0001), and warfarin ($511; P <0.0001 and $63; P <0.0001) patients. Among anticoagulant-naive moderate-to-high risk NVAF patients encountered in real-world clinical setting, major bleeding was lower with apixaban compared to warfarin and rivaroxaban. Bleeding costs were lower with apixaban compared to alternative NOACs and warfarin.

scholarly journals Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin

2016 ◽  
Vol 116 (11) ◽  
pp. 975-986 ◽  
Author(s):  
Allison Keshishian ◽  
Shital Kamble ◽  
Xianying Pan ◽  
Jack Mardekian ◽  
Ruslan Horblyuk ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Proportional Hazards ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Baseline Period ◽  
Cox Proportional Hazards ◽  
Significant Difference

SummaryIn addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in ‘real world’ clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013–31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012–31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39–0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50–0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83–1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36–2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.

Abstract 17609: Comparison of All-cause and Bleeding-related Hospitalizations Among Non-valvular Atrial Fibrillation Patients Receiving Oral Anticoagulants

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Steve Deitelzweig ◽  
Amanda Bruno ◽  
Kiran Gupta ◽  
Jeffrey Trocio ◽  
Natalie Tate
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Hazard Ratios ◽  
Prescription Date

To compare the risk of hospitalization among non-valvular atrial fibrillation (NVAF) patients newly initiated with an oral anticoagulant (OAC): apixaban, dabigatran, rivaroxaban, or warfarin. Retrospective cohort study using Humana Medicare Advantage data from 7/1/2009 - 9/30/2014. NVAF patients ≥18 years receiving one OAC on the index date with 6 months continuous enrollment prior to index prescription date and 3 months post-index were eligible. Hospitalizations were identified by standard codes for inpatient admission. Bleeding-related hospitalizations required an additional code for major/clinically relevant non-major (CRNM) bleeding. A cox proportional hazards model was used to estimate the hazard ratios (HR) of hospitalizations adjusted for age, sex, region, comorbidities and comedications. Adherence for each OAC was also calculated using a proportion of days covered approach to understand medication taking behaviors. Among the 53,168 patients initiated on an OAC, 2,028 (3.8%) apixaban, 5,644 (10.6%) dabigatran, 7,667 (14.4%) rivaroxaban and 37,829 (71.1%) warfarin. Patients in apixaban cohort were older (mean 75.5 years, P <0.05) with higher mean CHA 2 DS 2- VASc score (P <0.05). Abixaban patients had a higher mean HAS-BLED score vs. dabigatran (P <0.0001), lower mean score vs. warfarin (P <0.0001) and did not differ significantly vs. rivaroxaban (P =0.46). Patients receiving apixaban had a significantly lower risk for all-cause hospitalization across cohorts, and a sig. lower risk for bleeding-related hospitalization vs. patients receiving rivaroxaban or warfarin (Table). Adherence ranged from 87.8% to 90.4% across cohorts. In a real-world setting, initiation with apixaban was associated with a significantly lower risk for all-cause hospitalization, and a significantly lower risk of bleeding-related hospitalization compared to rivaroxaban or warfarin. Table: Adjusted Hazard Ratios of All-cause and Bleeding-related Hospitalizations

P1255Comparative safety and effectiveness of standard doses of apixaban versus dabigatran, rivaroxaban, and VKAs in non-valvular atrial fibrillation patients in France: the NAXOS study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Danchin ◽  
P G Steg ◽  
O Hanon ◽  
I Mahe ◽  
M Belhassen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Propensity Scores ◽  
Standard Dose ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Forest Plot ◽  
All Cause Mortality

Abstract Background Real-world data comparing all available oral anticoagulants (OAC) on a nationwide scale (i.e. in France: apixaban, rivaroxaban, dabigatran and vitamin K antagonists – VKAs) are lacking. In everyday practice, oral anticoagulants are often underdosed, which may render comparisons between agents difficult. Purpose and methods NAXOS is a French real-world study comparing the safety (major bleeding), effectiveness (stroke, systemic thromboembolic events (STE)) and all-cause mortality for apixaban, dabigatran, rivaroxaban, and VKAs, in adult patients with non-valvular atrial fibrillation (NVAF) initiating a given OAC between 2014 and 2016. The French national health insurance data (SNIIRAM) were used. Analyses were performed with adjustment on propensity scores. To avoid bias potentially related to underdosing, the present analysis included only patients receiving standard doses of apixaban (5mg bid), rivaroxaban (20mg od), and dabigatran (150 mg bid), or VKAs. Only OAC naïve patients were included. Results In the OAC-naive cohorts treated with apixaban, rivaroxaban, and dabigatran, 54,575 (62.3%), 65,208 (65.2%), and 9,000 (42.4%), respectively, had the standard dose at the index dispensation, and 112,628 patients received VKAs. After adjustment on propensity scores, apixaban 5 mg was associated with a lower risk of major bleeding, compared to VKAs (Hazard Ratio: 0.47; 95% CI: 0.43–0.51) and rivaroxaban 20mg (HR: 0.64; 0.59–0.71), but not to dabigatran 150 mg (HR: 0.97; 0.79–1.18). Apixaban was associated with a lower risk of stroke and STE, compared to VKAs (HR: 0.62; 0.56–0.69) but not to rivaroxaban (HR: 1.03; 0.92–1.16), and dabigatran (HR: 0.96; 0.76–1.21). Apixaban showed a lower risk of all-cause mortality compared to VKAs (HR: 0.44; 0.41–0.47) and rivaroxaban (HR: 0.87; 0.81–0.94) but not to dabigatran (HR: 1.10; 0.92–1.32). Figure 1. Forest plot presenting the results of the standard dose analysis (PS adjusted). Conclusions The NAXOS population-based country-wide observational study shows that 42% to 65% of patients were treated with standard doses of OACs. Analyses of standard doses confirmed the superiority of apixaban compared with VKAs for the three studied outcomes and suggests better safety profile of apixaban compared to rivaroxaban but similar to dabigatran. Acknowledgement/Funding The Alliance Bristol-Myers Squibb/Pfizer

Abstract 339: Hospitalization Rates and Healthcare Costs Among Non-valvular Atrial Fibrillation Patients Who Were Naïve Users of Novel Oral Anticoagulants

2015 ◽  
Vol 8 (suppl_2) ◽  
Author(s):  
Steve Deitelzweig ◽  
Amanda Bruno ◽  
Natalie Tate ◽  
Augustina Ogbonnaya ◽  
Manan Shah ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Index Date ◽  
Proportional Hazards Model ◽  
Oral Anticoagulants ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Novel Oral Anticoagulants ◽  
Early Assessment

Background: Novel oral anticoagulants (NOACs) are recommended for stroke risk reduction in non-valvular atrial fibrillation (NVAF) patients withCHADS 2 ≥2. Efficacy and safety of the different NOACs are well documented in the clinical trial setting, however, real-world evidence of the effectiveness and safety of these agents is limited. This study provides an early assessment of all-cause hospitalizations and economic outcomes among NVAF patients initiated on different NOAC treatments in the real-world. Methods: A retrospective cohort study of patients diagnosed with AF (ICD-9-CM 427.31 and 427.32) who were naïve to anticoagulant therapy and initiated on a NOAC (dabigatran, rivaroxaban and apixaban) was conducted using PharMetrics Plus data from 01/ 2012 through 03/2014. The first NOAC prescription date served as the index date. Patients were required to be ≥18 years old and have no evidence of valvular disease, CHADS 2 score ≥ 1, and ≥ 1 month of follow-up. Follow-up ended upon the earliest of the following: treatment discontinuation, switch to a different NOAC, end of continuous enrollment, 1 year after the index date, or end of study. A Cox proportional hazards model were used to model the likelihood and timing of all-cause hospitalizations while a generalized linear model (GLM) was used for costs. Results: There were 9,150 patients included in the study. The majority of patients were prescribed rivaroxaban (61.5%), followed by dabigatran 1,374 (23.5%), and apixaban (15.0%). Males were 71.4% of the sample and mean age was 63.4 years, with the apixaban patients being slightly older (P=0.0170). Mean CHADS 2 score was 1.8. Mean HAS-BLED score was 2.0, and was slightly higher for patients on apixaban and rivaroxaban (P=0.0025). After adjusting for baseline characteristics, treatment with dabigatran (HR 1.37, 95% CI 1.10-1.69) and rivaroxaban (HR 1.57, 95% CI 1.30-1.90) was associated with increased rate of all-cause hospitalization relative to apixaban. Mean monthly all-cause costs were lower for patients on apixaban compared to those on dabigatran ($3,581 vs $4,236; P<0.0001) and rivaroxaban ($3,581 vs $4,144; P<0.0001). Conclusions: This early assessment shows that among anticoagulant naïve NVAF patients, treatment with apixaban was associated with a lower rate of all-cause hospitalization, as well as lower overall costs compared to other NOACs. Further evaluation is needed to provide additional detail on potential drivers of utilization differences.

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.

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

Abstract 17617: History of Bleeding and Outcomes with Apixaban versus Warfarin in Patients with Atrial Fibrillation in the ARISTOTLE Trial

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Raffaele De Caterina ◽  
Ulrika Andersson ◽  
John H Alexander ◽  
M.Cecilia Bahit ◽  
Patrick J Commerford ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Weight ◽  
Major Bleeding ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Channel Blockers ◽  
Chads2 Score ◽  
History Of

Background: History of bleeding is important in decisions for anticoagulation. We analyzed outcomes in relation to history of bleeding and randomized treatments in patients with atrial fibrillation (AF) in the ARISTOTLE trial. Methods: The on-treatment safety population included 18,140 patients receiving ≥1 dose of study drug, apixaban 5 mg bd (2.5 mg bd if 2 of the following: age >80 yrs; body weight <60 kg; or creatinine >133 μmol/L) or warfarin aiming for INR 2.0-3.0 (median TTR 66%), for a median of 1.8 yrs. Adjudicated outcomes in relation to randomization and history of bleeding were analyzed using a Cox proportional hazards model. Efficacy endpoints were analyzed in the intention-to-treat population. Results: A history of bleeding was reported in 3033 patients (16.7%), who more often were male (68% vs 64%, p <0.0005); with a history of prior stroke/TIA/systemic embolism (23% vs 19%, p <0.0001); diabetes (27% vs 24%, p=0.0010); higher CHADS2 score (CHADS2 >3: 35% vs 29%), age (mean [SD] 71 [9] vs 69 [10], p <0001) and body weight (86 [21] vs 84 [21], p <0.0001); lower creatinine clearance (77 [33] vs 80 [33], p=0.0007) and mean systolic blood pressure (131 [17] vs 132 [16], p=0.0027). Calcium channel blockers, statins, non-steroidal anti-inflammatory drugs and proton pump inhibitors were used more often in patients with vs without a history of bleeding. Major bleeding was the only outcome event occurring more frequently in patients with vs without a history of bleeding, HR 1.7 (95% CI 1.4-2.3) with apixaban and 1.5 (1.2-1.0) with warfarin. Primary efficacy and safety outcomes in relation to randomization, see Table. Conclusions: In patients with AF, a history of bleeding was associated with several risk factors for stroke and bleeding and, accordingly, a higher bleeding risk during anticoagulation. Benefits with apixaban vs warfarin as to stroke, mortality and major bleeding, are however consistent irrespective of bleeding history.

scholarly journals Comparative Effectiveness and Safety of Oral Anticoagulants Across Kidney Function in Patients With Atrial Fibrillation

2020 ◽  
Vol 13 (10) ◽  
Author(s):  
Xiaoxi Yao ◽  
Jonathan W. Inselman ◽  
Joseph S. Ross ◽  
Rima Izem ◽  
David J. Graham ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Glomerular Filtration Rate ◽  
Glomerular Filtration ◽  
Kidney Function ◽  
Major Bleeding ◽  
Comparative Effectiveness ◽  
Lower Risk ◽  
Filtration Rate ◽  
Estimated Glomerular Filtration Rate ◽  
Oral Anticoagulants

Background: Patients with atrial fibrillation and severely decreased kidney function were excluded from the pivotal non–vitamin K antagonist oral anticoagulants (NOAC) trials, thereby raising questions about comparative safety and effectiveness in patients with reduced kidney function. The study aimed to compare oral anticoagulants across the range of kidney function in patients with atrial fibrillation. Methods and Results: Using a US administrative claims database with linked laboratory data, 34 569 new users of oral anticoagulants with atrial fibrillation and estimated glomerular filtration rate ≥15 mL/(min·1.73 m 2 ) were identified between October 1, 2010 to November 29, 2017. The proportion of patients using NOACs declined with decreasing kidney function—73.5%, 69.6%, 65.4%, 59.5%, and 45.0% of the patients were prescribed a NOAC in estimated glomerular filtration rate ≥90, 60 to 90, 45 to 60, 30 to 45, 15 to 30 mL/min per 1.73 m 2 groups, respectively. Stabilized inverse probability of treatment weighting was used to balance 4 treatment groups (apixaban, dabigatran, rivaroxaban, and warfarin) on 66 baseline characteristics. In comparison to warfarin, apixaban was associated with a lower risk of stroke (hazard ratio [HR], 0.57 [0.43–0.75]; P <0.001), major bleeding (HR, 0.51 [0.44–0.61]; P <0.001), and mortality (HR, 0.68 [0.56–0.83]; P <0.001); dabigatran was associated with a similar risk of stroke but a lower risk of major bleeding (HR, 0.57 [0.43–0.75]; P <0.001) and mortality (HR, 0.68 [0.48-0.98]; P =0.04); rivaroxaban was associated with a lower risk of stroke (HR, 0.69 [0.51–0.94]; P =0.02), major bleeding (HR, 0.84 [0.72–0.99]; P =0.04), and mortality (HR, 0.73 [0.58–0.91]; P =0.006). There was no significant interaction between treatment and estimated glomerular filtration rate categories for any outcome. When comparing one NOAC to another NOAC, there was no significant difference in mortality, but some differences existed for stroke or major bleeding. No relationship between treatments and falsification end points was found, suggesting no evidence for substantial residual confounding. Conclusions: Relative to warfarin, NOACs are used less frequently as kidney function declines. However, NOACs appears to have similar or better comparative effectiveness and safety across the range of kidney function.

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