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 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 Bleeding Risk in Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants and Warfarin: A Systematic Review and Meta-Analysis of Observational Studies

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3672-3672 ◽  
Author(s):  
Yimin Pearl Wang ◽  
Rohan Kehar ◽  
Alla Iansavitchene ◽  
Alejandro Lazo-Langner
Keyword(s):  
Major Bleeding ◽  
Lower Risk ◽  
Observational Studies ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Bleeding Risk ◽  
Risk Of Bleeding ◽  
Significant Difference

Introduction: The standard oral anticoagulant therapy administered to non-valvular AF patients has typically been Vitamin K Antagonists (VKA) particularly warfarin. In recent years, Direct Oral Anticoagulants (DOACs) including Direct Thrombin Inhibitors (DTI) and Direct Factor Xa inhibitors (FXa inhibitors) have become an alternative to warfarin. Randomized trials comparing warfarin and DOACs showed comparable effectiveness without significant additional major bleeding risk. However, bleeding events in RCTs may differ from those in daily use due to the routine exclusion of patients with a higher risk of bleeding from many studies. We aimed to assess bleeding risk between DOACs and warfarin in AF patients in observational studies and we also sought to determine differences between patients that were experienced or naïve to oral anticoagulants. Methods: A systematic literature search was conducted in the OVID MEDLINE® and EMBASE® electronic databases. Observational studies and randomized control trials (RCT) from 1990 to January 2019 were retrieved and examined by two independent reviewers. A pooled effect hazard ratio (HR) was calculated using a random effects model using the generic inverse variance method. Subgroup analyses according to previous exposure to anticoagulants, study type, funding type and DOAC type were conducted. The primary outcome was major bleeding risk. The secondary outcome was clinically relevant non-major bleeding. All studies must have used an established or validated definition of major bleeding. Results: The initial literature search identified 3359 potentially eligible citations. After primary screening, 150 articles were eligible for full text review and there were 35 studies including 2,356,201 patients that met the inclusion criteria. Overall, patients on DOACs were less likely to experience a bleeding event compared to warfarin (HR 0.78, 95%CI 0.71, 0.85, P&lt;0.001). The results were consistent when analyzing patients receiving DTIs or FXa inhibitors (DTI: HR 0.76, 95% CI 0.67,0.87; FXa inhibitors: HR 0.79, 95% CI 0.69,0.89). However, among patients receiving factor Xa inhibitors, there was a significant difference in the risk of bleeding according to individual drug. Among patients receiving rivaroxaban the risk of bleeding was similar to warfarin (HR 0.98, 95%CI 0.91,1.06, p=0.60) whereas in those receiving apixaban there was a 40% reduction in the risk of bleeding compared to warfarin (HR 0.60, 95%CI 0.50,0.71, p&lt;0.001) (Figure 1). Three studies reported information according to previous anticoagulant exposure. The overall pooled hazard ratio was 0.68 (95% CI 0.55, 0.82 p&lt;0.001) in favor of patients on DOACs. In the subgroup analysis of previous anticoagulant use, the risk of bleeding was lower for DOACs compared to warfarin in both the experienced population (HR 0.70, 95%CI 0.51, 0.96) and the naïve population (HR 0.64, 95% CI 0.47,0.87). However, heterogeneity was moderate to high among both subgroups. Conclusion: This review and meta-analysis of observational studies including over 2.3 million patients showed that overall DOACs have a lower risk of major bleeding and clinically relevant non-major bleeding compared to warfarin. Most importantly, although the pooled effect estimate did not differ between DTIs and FXa inhibitors, among patients receiving FXa inhibitors there was a significant difference between individual agents. Patients on apixaban had a significantly lower risk of bleeding compared to warfarin in contrast to patients on rivaroxaban who had a similar risk. Disclosures No relevant conflicts of interest to declare.

scholarly journals Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in “real-world” clinical practice

2017 ◽  
Vol 117 (06) ◽  
pp. 1072-1082 ◽  
Author(s):  
Xiaoyan Li ◽  
Steve Deitelzweig ◽  
Allison Keshishian ◽  
Melissa Hamilton ◽  
Ruslan Horblyuk ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Proportional Hazards ◽  
Significant Risk ◽  
Haemorrhagic Stroke ◽  
Cox Proportional Hazards ◽  
Kaplan Meier ◽  
Cox Proportional Hazards Models ◽  
Warfarin Treatment

SummaryThe ARISTOTLE trial showed a risk reduction of stroke/systemic embolism (SE) and major bleeding in non-valvular atrial fibrillation (NVAF) patients treated with apixaban compared to warfarin. This retrospective study used four large US claims databases (MarketScan, PharMetrics, Optum, and Humana) of NVAF patients newly initiating apixaban or warfarin from January 1, 2013 to September 30, 2015. After 1:1 warfarin-apixaban propensity score matching (PSM) within each database, the resulting patient records were pooled. Kaplan-Meier curves and Cox proportional hazards models were used to estimate the cumulative incidence and hazard ratios (HRs) of stroke/SE and major bleeding (identified using the first listed diagnosis of inpatient claims) within one year of therapy initiation. The study included a total of 76,940 (38,470 warfarin and 38,470 apixaban) patients. Among the 38,470 matched pairs, 14,563 were from MarketScan, 7,683 were from PharMetrics, 7,894 were from Optum, and 8,330 were from Humana. Baseline characteristics were balanced between the two cohorts with a mean (standard deviation [SD]) age of 71 (12) years and a mean (SD) CHA2DS2-VASc score of 3.2 (1.7). Apixaban initiators had a significantly lower risk of stroke/SE (HR: 0.67, 95 % CI: 0.59–0.76) and major bleeding (HR: 0.60, 95 % CI: 0.54–0.65) than warfarin initiators. Different types of stroke/SE and major bleeding – including ischaemic stroke, haemorrhagic stroke, SE, intracranial haemorrhage, gastrointestinal bleeding, and other major bleeding – were all significantly lower for apixaban compared to warfarin treatment. Subgroup analyses (apixaban dosage, age strata, CHA2DS2-VASc or HAS-BLED score strata, or dataset source) all show consistently lower risks of stroke/SE and major bleeding associated with apixaban as compared to warfarin treatment. This is the largest “real-world” study on apixaban effectiveness and safety to date, showing that apixaban initiation was associated with significant risk reductions in stroke/SE and major bleeding compared to warfarin initiation after PSM. These benefits were consistent across various high-risk subgroups and both the standard-and low-dose apixaban dose regimens.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.

Abstract 15467: Impact of Thrombocytopenia on Clinical Outcomes in Atrial Fibrillation Patients With Anemia: The Fushimi Af Registry

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
KOSUKE DOI ◽  
Yasuhiro Hamatani ◽  
Akiko Fujino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Antithrombotic Drugs ◽  
Prospective Survey ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Independent Determinant

Introduction: Anemia has been reported to be associated with poor prognosis in patients with atrial fibrillation (AF). Concomitant thrombocytopenia (TP) may or may not affect the prescription of antithrombotic drugs and clinical outcomes in these patients. Methods: The Fushimi AF Registry is a community-based prospective survey of AF patients in Fushimi-ku, Kyoto. We defined TP as platelet counts less than 150,000/μL and anemia as hemoglobin less than 11 g/dL. Among 666 patients with anemia, we compared the clinical backgrounds and outcomes of those with TP (n=183) and those without (n=483). Results: Compared with patients without TP, patients with TP were more likely to have chronic kidney disease (75.4% vs. 61.8%, p=0.001), and less likely to have hypertension (58.5% vs. 67.0%, p=0.0393), and less likely to have dyslipidemia (27.3% vs. 38.3%, p=0.0079). Age, sex, body weight, CHADS 2 score, CHA 2 DS 2 -VASc score, HAS-BLED score, and previous major bleeding were comparable between the groups. Furthermore, prescription of anti-thrombotic drugs was comparable (Figure A). On Kaplan-Meier analysis, the incidence of all-cause death was higher in TP group (hazard ratio [HR] 1.52; 95% confidence interval [CI] 1.20-1.91, p<0.05) (Figure B-1). There was no significant difference in other adverse events between patients with and without TP (major bleeding: HR 1.11; 95% CI 0.41-3.31, p=0.8, hospitalization for heart failure: HR 1.11; 95% CI 0.74-1.61, p= 0.61 and stroke or systemic embolism: HR 0.91; 95% CI 0.43-1.78, p=0.80) (Figure B-2, 3, 4). Multivariate Cox proportional hazards regression analysis adjusting for potential confounders revealed that TP was an independent determinant of all-cause death (adjusted HR: 1.41, 95% CI; 1.11-1.78, p=0.006). Conclusions: Concomitant TP in AF patients with anemia did not affect the prescription of antithrombotic drugs, and was independently associated with all-cause death in the Fushimi AF Registry.

scholarly journals Comparative clinical outcomes between direct oral anticoagulants and warfarin among elderly patients with non-valvular atrial fibrillation in the CMS medicare population

2019 ◽  
Vol 48 (2) ◽  
pp. 240-249 ◽  
Author(s):  
Alpesh Amin ◽  
Allison Keshishian ◽  
Oluwaseyi Dina ◽  
Amol Dhamane ◽  
Anagha Nadkarni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Proportional Hazards ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Cox Proportional Hazards ◽  
Cardiac Events ◽  
Cox Proportional Hazards Models ◽  
Medicare Patients ◽  
Similar Risk

AbstractAtrial fibrillation (AF) prevalence increases with age; > 80% of US adults with AF are aged ≥ 65 years. Compare the risk of stroke/systemic embolism (SE), major bleeding (MB), net clinical outcome (NCO), and major adverse cardiac events (MACE) among elderly non-valvular AF (NVAF) Medicare patients prescribed direct oral anticoagulants (DOACs) vs warfarin. NVAF patients aged ≥ 65 years who initiated DOACs (apixaban, dabigatran, and rivaroxaban) or warfarin were selected from 01JAN2013-31DEC2015 in CMS Medicare data. Propensity score matching was used to balance DOAC and warfarin cohorts. Cox proportional hazards models estimated the risk of stroke/SE, MB, NCO, and MACE. 37,525 apixaban–warfarin, 18,131 dabigatran–warfarin, and 55,359 rivaroxaban–warfarin pairs were included. Compared to warfarin, apixaban (HR: 0.69; 95% CI 0.59–0.81) and rivaroxaban (HR: 0.82; 95% CI 0.73–0.91) had lower risk of stroke/SE, and dabigatran (HR: 0.88; 95% CI 0.72–1.07) had similar risk of stroke/SE. Apixaban (MB: HR: 0.61; 95% CI 0.57–0.67; NCO: HR: 0.64; 95% CI 0.60–0.69) and dabigatran (MB: HR: 0.79; 95% CI 0.71–0.89; NCO: HR: 0.84; 95% CI 0.76–0.93) had lower risk of MB and NCO, and rivaroxaban had higher risk of MB (HR: 1.08; 95% CI 1.02–1.14) and similar risk of NCO (HR: 1.04; 95% CI 0.99–1.09). Compared to warfarin, apixaban had a lower risk for stroke/SE, MB, and NCO; dabigatran had a lower risk of MB and NCO; and rivaroxaban had a lower risk of stroke/SE but higher risk of MB. All DOACs had lower risk of MACE compared to warfarin.

Abstract 20218: Comparative Effectiveness of Dabigatran and Rivaroxaban versus Warfarin in Patients With Non-Valvular Atrial Fibrillation

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Lindsay Bengtson ◽  
Lin Chen ◽  
Richard MacLehose ◽  
Pamela Lutsey ◽  
Alvaro Alonso
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Real World ◽  
Proportional Hazards ◽  
Oral Anticoagulants ◽  
Cox Proportional Hazards ◽  
Intracranial Bleeding ◽  
Gi Bleeding ◽  
Pharmacy Claims ◽  
The Us

Background: In randomized trials, the new oral anticoagulants (NOAC) dabigatran and rivaroxaban have been at least as efficacious as warfarin in the prevention of ischemic stroke in patients with non-valvular atrial fibrillation (NVAF). Information on the effectiveness of NOACs versus warfarin in real-world populations in the US is more limited. Methods: We used data from the US MarketScan Commercial and Medicare Supplemental databases in the period 2010-12. We selected patients initiating oral anticoagulants after NVAF diagnosis, and with at least 6 months of enrollment before first anticoagulant use. Patients initiating dabigatran or rivaroxaban were matched with up to 5 warfarin users by age, sex, and time in the database. Outcomes of interest (ischemic stroke, intracranial bleeding, and gastrointestinal [GI] bleeding) were defined according to validated algorithms. Information on other comorbidities and medication use was obtained from inpatient, outpatient, and pharmacy claims. High-dimensional propensity score-adjusted Cox proportional hazards regression was used to estimate the association of NOACs vs warfarin with each outcome of interest. Results: The analysis included 32,918 dabigatran, 3,301 rivaroxaban and 92,633 warfarin users with NVAF. During an average 13-month follow-up (6 for rivaroxaban, 15 for dabigatran), 1035 ischemic strokes, 225 intracranial bleeds, and 1842 GI bleeds were identified. Rate of ischemic stroke was similar in patients initiating NOACs compared to those on warfarin. However, rate of intracranial bleeding was lower in patients using NOACs compared to warfarin users, while GI bleeding rate was higher in dabigatran users than warfarin users (Table). Conclusion: In this large real-world patient population, effectiveness of NOACs (compared to warfarin) for diverse outcomes was comparable to efficacy reported in the RE-LY and ROCKET-AF trials.

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.

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

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

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

Abstract 16866: Blood Pressure Control and Stroke or Bleeding Risk in Patients with Atrial Fibrillation: Results from the ROCKET AF Trial

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Sreekanth Vemulapalli ◽  
Anne S Hellkamp ◽  
W. Schuyler Jones ◽  
Jonathan P Piccini ◽  
Kenneth W Mahaffey ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Major Bleeding ◽  
Hemorrhagic Stroke ◽  
Proportional Hazards ◽  
Bleeding Risk ◽  
Cox Proportional Hazards ◽  
Adjusted Risk ◽  
History Of ◽  
Stage 1

Background: Hypertension (HTN) is a risk factor for stroke and bleeding in atrial fibrillation (AF). Yet, the association between HTN stage and stroke and bleeding risk in AF is unknown. Methods: The study population included 14,256 of the patients randomized in the ROCKET AF trial. Baseline systolic blood pressure (SBP) and history of HTN were determined and categorized as follows: (1) no history of HTN, (2) controlled HTN (SBP <140), (3) stage 1 HTN (SBP 140-159), and (4) stage 2 HTN (SBP ≥160). Cox proportional hazards models were used to compare event rates for stroke or systemic embolism (SE) and major bleeding. Results: Of the 90.5% of patients in ROCKET AF with HTN, 55.9% were controlled and 34.6% had stage 1 or 2 HTN. Compared with those with HTN, those without HTN had lower mean CHADS 2 scores (2.8 vs. 3.5), lower rates of prior myocardial infarction (11% vs. 18%), and lower mean age (69 vs. 73 years). Compared with those with no history of HTN, there was a trend towards an increased adjusted risk of stroke or SE in patients with controlled HTN (HR 1.22, 95% CI 0.89-1.66) and stage 1 or 2 HTN (HR 1.42, 95% CI 1.03-1.95) (p=0.06). A similar trend in adjusted risk of hemorrhagic stroke (controlled HTN: HR 2.50, 95% CI 0.89-7.05; stage 1 or 2 HTN: HR 3.04, 95% CI 1.06-8.71) (p=0.11) was observed. The effect of HTN stage on stroke risk did not vary by baseline CHADS 2 score (p interaction=0.70). The adjusted risk of major bleeding was not different between groups (HR 0.96, 95% CI 0.74-1.23; HR 1.00, 95% CI 0.77-1.30) (p=0.84). The benefit of rivaroxaban versus warfarin in preventing stroke or SE was consistent among patients regardless of baseline SBP (p interaction=0.69). Conclusion: One-third of patients in a clinical trial of AF had uncontrolled SBP at baseline. Uncontrolled SBP showed a trend towards a higher risk of stroke or SE, but not bleeding. Uncontrolled SBP may be an important factor in reducing the overall risk of stroke, and specifically hemorrhagic stroke, in patients with AF.

The Risk of Acute Kidney Injury with Oral Anticoagulants in Elderly Adults with Atrial Fibrillation

2021 ◽  
pp. CJN.05920421
Author(s):  
Ziv Harel ◽  
Eric McArthur ◽  
Nivethika Jeyakumar ◽  
Manish Sood ◽  
Amit Garg ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Kidney Injury ◽  
Lower Risk ◽  
Propensity Scores ◽  
Proportional Hazards ◽  
Oral Anticoagulants ◽  
Kidney Injury ◽  
International Normalized Ratio ◽  
Population Based ◽  
Cox Proportional Hazards

Background: Anticoagulation with either with a vitamin K antagonist or a direct oral anticoagulant (DOAC) may be associated with acute kidney injury (AKI). Our objective was to assess the risk of AKI among elderly individuals with atrial fibrillation (AF) newly prescribed a DOAC (dabigatran, rivaroxaban, or apixaban) versus warfarin. Methods: A population-based cohort study of 20,683 outpatients in Ontario, Canada, ≥66 years, with atrial fibrillation who were prescribed warfarin, dabigatran, rivaroxaban or apixaban between 2009- 2017. Inverse probability of treatment weighting based on derived propensity scores for the treatment with each DOAC was used to balance baseline characteristics among patients receiving each of the three DOACs, compared to warfarin. Cox proportional hazards regression was performed in the weighted population to compare the association between the prescribed anticoagulant and the outcomes of interest. The exposure was an outpatient prescription of warfarin, or one of the DOACs. The primary outcome was a hospital encounter with AKI, defined using KDIGO thresholds. Prespecified subgroup analyses were conducted by estimated glomerular filtration rate (eGFR) category, and by the percentage of international normalized ratio measurements in range, a validated marker of anticoagulation control. Results: : Each DOAC was associated with a significantly lower risk of AKI compared to warfarin (weighted HR 0.65; 95% CI 0.53 to 0.80 for dabigatran, weighted HR 0.85; 95% CI 0.73 to 0.98 for rivaroxaban; and weighted HR 0.81; 95% CI 0.72 to 0.93 for apixaban). In subgroup analysis, the lower risk of AKI associated with each DOAC was consistent across each eGFR strata. The risk of AKI was significantly lower among users of each of the DOACs compared to warfarin users who had a percentage of international normalized ratio measurements ≤56.1%. Conclusions: DOACs were associated with a lower risk of AKI compared to warfarin.

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