scholarly journals Rivaroxaban Versus Warfarin for Management of Obese African Americans With Non-Valvular Atrial Fibrillation or Venous Thromboembolism: A Retrospective Cohort Analysis

2020 ◽  
Vol 26 ◽  
pp. 107602962095491
Author(s):  
Olivia S. Costa ◽  
Jan Beyer-Westendorf ◽  
Veronica Ashton ◽  
Dejan Milentijevic ◽  
Kenneth Todd Moore ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
African Americans ◽  
Major Bleeding ◽  
Cox Regression ◽  
Cohort Analysis ◽  
Bleeding Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Thrombotic Risk ◽  
Hazard Ratios

African Americans (AAs) and obese individuals have increased thrombotic risk. This study evaluated the effectiveness and safety of rivaroxaban versus warfarin in obese, AAs with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Optum® De-Identified Electronic Health Record (EHR) data was used to perform separate propensity-score matched analyses of adult, oral anticoagulant (OAC)-naïve AAs with NVAF or acute VTE, respectively; who had a body mass index≥30kg/m2 and ≥12-months EHR activity with ≥1-encounter before OAC initiation. Cox regression was performed and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). For the NVAF analysis, 1,969 rivaroxaban- and 1,969 warfarin-users were matched. Rivaroxaban was not associated with a difference in stroke/systemic embolism versus warfarin (HR = 0.88, 95%CI = 0.60-1.28), but less major bleeding (HR = 0.68, 95%CI = 0.50-0.94) was observed. Among 683 rivaroxaban-users with VTE, 1:1 matched to warfarin-users, rivaroxaban did not alter recurrent VTE (HR = 1.36, 95%CI = 0.79-2.34) or major bleeding (HR = 0.80, 95%CI = 0.37-1.71) risk versus warfarin at 6-months (similar findings observed at 3- and 12-months). Rivaroxaban appeared to be associated with similar thrombotic, and similar or lower major bleeding risk versus warfarin in these obese, AA cohorts.

scholarly journals Major Bleeding Risk During Anticoagulation with Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients with Nonvalvular Atrial Fibrillation

2017 ◽  
Vol 23 (9) ◽  
pp. 968-978 ◽  
Author(s):  
Gboyega Adeboyeje ◽  
Gosia Sylwestrzak ◽  
John J. Barron ◽  
Jeff White ◽  
Alan Rosenberg ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Bleeding Risk ◽  
Nonvalvular Atrial Fibrillation

P4778Effectiveness and safety of rivaroxaban versus warfarin in nonvalvular atrial fibrillation patients with coronary or peripheral artery disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C I Coleman ◽  
N Sood ◽  
T J Bunz ◽  
D Eriksson ◽  
A.-K Meinecke ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Peripheral Artery Disease ◽  
Major Bleeding ◽  
Data Availability ◽  
Routine Practice ◽  
Peripheral Artery ◽  
Nonvalvular Atrial Fibrillation ◽  
Hazard Ratios ◽  
Significant Difference ◽  
Artery Disease

Abstract Background The efficacy and safety of rivaroxaban use for the prevention of major thrombotic vascular events (MTVEs) has been demonstrated in randomized trials of nonvalvular atrial fibrillation (NVAF), coronary artery disease (CAD) and peripheral artery disease (PAD) patients. Purpose To assess the effectiveness and safety of rivaroxaban versus warfarin in preventing MTVEs in NVAF patients with concomitant CAD and/or PAD in routine practice. Methods Using MarketScan data from 1/2012–12/2017, we identified oral anticoagulant (OAC)-naïve NVAF patients with comorbid CAD and/or PAD and ≥12-months of insurance coverage before OAC initiation. Differences in baseline covariates between cohorts were adjusted using inverse probability-of-treatment weights based on propensity-scores (standardized differences <0.1 achieved for all covariates after adjustment). The primary effectiveness endpoint was the composite of any MTVE including ischemic stroke, myocardial infarction or adverse limb event (revascularization or amputation). The primary safety endpoint was major bleeding defined using the Cunningham algorithm. Patients were followed until a MTVE, discontinuation or switch of index OAC, insurance disenrollment or end-of-data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the cohorts were calculated using Cox regression. Results We identified 3,257 rivaroxaban (30.4% received a reduced dose) and 5,046 warfarin users with NVAF and comorbid CAD and/or PAD. Median (25%-75% range) age was 74 (65–81) years, CHA2DS2-VASc score was 3 (2–4). Rivaroxaban was associated with a 32% (95% CI=8–50%) reduction in the composite of any MTVE (Figure). No significant difference in major bleeding was observed (HR=1.13, 95% CI=0.84–1.52). Figure 1. Event Rates and Hazard Ratios Conclusions In patients with NVAF and comorbid CAD and/or PAD treated in routine practice, rivaroxaban use appears to reduce patients' risk of MTVEs compared to warfarin, without increasing their risk of major bleeding. This study lends further support to RCT findings that suggest rivaroxaban is effective in preventing major events in multiple vascular beds. Acknowledgement/Funding Bayer AG, Berlin, Germany

Mild kidney disease as a risk factor for major bleeding in patients with atrial fibrillation undergoing percutaneous coronary stenting

2012 ◽  
Vol 107 (01) ◽  
pp. 51-58 ◽  
Author(s):  
Francisco Cambronero ◽  
Cesar Caro-Martínez ◽  
Jose A. Hurtado-Martínez ◽  
Francisco Marín ◽  
Francisco J. Pastor-Pérez ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Kidney Disease ◽  
Major Bleeding ◽  
Cox Regression ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Cox Regression Analysis ◽  
Percutaneous Coronary ◽  
One Year

SummaryBleeding risk is increased in patients with atrial fibrillation (AF) and moderate to severe kidney disease (KD); however, the implication of mild KD on bleeding remains unclear. The aim of this study was to determine whether the presence of mild KD increases risk for major bleeding (MB) in patients with AF undergoing percutaneous coronary intervention with stent implantation (PCI-S). Two hundred eighty-five patients were included. Patients were classified into three kidney function groups: moderate to severe KD (n=91; <60 ml/min/1.73 m2), mild KD (n=139; 60–89 ml/min/1.73 m2) and non-KD (n=55; ≥90 ml/min/1.73 m2). Estimated glomerular filtration rate was calculated using the simplified Modification of Diet in Renal Disease equation. Patients were followed for one year, and the occurrence of MB was obtained in all. A total of 28 patients (9.8%) presented MB. MB complications examined as a function of KD groups revealed that there was a graded increase in MB with worsening renal function (non KD=1.8%, mild KD=7.9%, moderate to severe KD=17.6%; p <0.001). Multivariable Cox regression analysis showed that mild KD was associated with nearly a 2.5-fold (2.43 95% confidence interval 1.11–5.34, p=0.039) increase in the risk of MB as compared with non-KD patients. Other independent predictors of MB were moderate-severe KD, anaemia and triple antithrombotic therapy after PCI-S (C-index=0.76). In this population, mild KD confers a significantly increase in the risk for MB complications. Future studies should assess the potential role of incorporating mild KD into the bleeding risk scales to improve the stratification of these patients.

Abstract 2: Comparative Effectiveness and Safety of Anticoagulant Therapy With Warfarin, Dabigatran, Apixaban, or Rivaroxaban in Patients With Nonvalvular Atrial Fibrillation

2016 ◽  
Vol 9 (suppl_2) ◽  
Author(s):  
Gboyega Adeboyeje ◽  
Gosia Sylwestrzak ◽  
Jeff White ◽  
Alan Rosenberg ◽  
Jacob Abarca ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Thromboembolic Event ◽  
Relative Effectiveness ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
The United States ◽  
Baseline Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Significant Difference

Background: The efficacy and safety of novel oral anticoagulants (NOACs) as alternatives to warfarin therapy in nonvalvular atrial fibrillation (NVAF) patients have been studied in randomized trials. Given the increasing use of NOACs, additional data is required to assess the relative effectiveness and safety of anticoagulation with warfarin, dabigatran, apixaban, or rivaroxaban therapy in real-world settings in the United States (U.S). Methods: A retrospective cohort study design was used to analyze data from a U.S. commercial claims database of > 38 million members. Study population included new users of warfarin, dabigatran, apixaban, or rivaroxaban aged ≥ 18 years with ≥ 2 diagnoses of NVAF from November 2010 to February 2015. The primary effectiveness outcome was a composite of thromboembolic event or stroke; the primary safety outcome was major bleeding event requiring hospitalization. Cox proportional hazards models with inverse probability of treatment weighting (IPTW) were used to compare event rates between NOAC and warfarin users, and among NOAC users. Results: In the final NVAF cohort studied, there were 23,431 warfarin, 8,539 dabigatran, 3,689 apixaban, and 8,398 rivaroxaban users. A total of 7,022 primary outcome events and 3,264 safety events were identified. Warfarin users were older than dabigatran, apixaban, or rivaroxaban users (mean: 73 vs 66 vs 69 vs 67 years). After IPTW, all treatment groups were balanced on all baseline risk factors including stroke and bleeding risk. Compared to warfarin, NOAC users had fewer thromboembolic events or strokes: dabigatran (hazard ratio HR, 0.77 [95% CI: 0.72 - 0.82]), apixaban (HR, 0.73 [CI: 0.65 - 0.82]), and rivaroxaban (HR, 0.80 [CI: 0.75 - 0.86]). Additionally, dabigatran ([HR], 0.67 [CI: 0.60 - 0.76]), and apixaban users (HR, 0.52 [CI: 0.41 - 0.67) experienced fewer major bleeding events compared to warfarin users. No significant difference was found in major bleeding risk between rivaroxaban (HR, 1.00 [CI: 0.89 - 1.12]) and warfarin users. All three NOAC groups had similar risks for thromboembolic event or stroke: dabigatran vs rivaroxaban (HR, 0.96 [CI: 0.88 - 1.05]); apixaban vs rivaroxaban (HR, 0.91 [CI: 0.80 - 1.04]); dabigatran vs apixaban (HR, 1.05 [CI: 0.93 - 1.19]). However, compared to rivaroxaban users, major bleeding risk was 33% and 48% lower in dabigatran and apixaban users respectively (HR, 0.67[CI: 0.58 - 0.78]) and HR, 0.52 [CI: 0.40 - 0.68]). Conclusions: Our results demonstrated a lower risk of a thromboembolic event or stroke among dabigatran, apixaban, or rivaroxaban users compared to warfarin users. Among NOACs, risks of a thromboembolic event or stroke were similar. Further studies are needed to clarify the finding of a higher major bleeding risk in warfarin and rivaroxaban users.

scholarly journals D-Dimer Measured at Diagnosis of Venous Thromboembolism is Associated with Risk of Major Bleeding

TH Open ◽  
2019 ◽  
Vol 03 (01) ◽  
pp. e77-e84 ◽  
Author(s):  
Håkon Johnsen ◽  
Kristian Hindberg ◽  
Esben Bjøri ◽  
Ellen Brodin ◽  
Sigrid Brækkan ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Cox Regression ◽  
Bleeding Risk ◽  
Predictive Biomarker ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
Patients At Risk ◽  
D Dimer

AbstractIdentification of patients at risk of major bleeding is pivotal for optimal management of anticoagulant therapy in venous thromboembolism (VTE). Studies have suggested that D-dimer may predict major bleeding during anticoagulation; however, this is scarcely investigated in VTE patients. We aimed to investigate the role of D-dimer, measured at VTE diagnosis, as a predictive biomarker of major bleeding. The study population comprised 555 patients with a first community-acquired VTE (1994–2016), who were identified among participants from the Tromsø study. Major bleeding events were recorded during the first year after VTE and defined according to the criteria of the International Society on Thrombosis and Haemostasis. Cox-regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs) adjusted for age, sex, and duration of anticoagulant therapy. In total, 29 patients experienced major bleeding (incidence rate: 5.7/100 person-years, 95% CI: 4.0–8.2). The major bleeding risk was highest during the first 3 months, especially in patients with D-dimer ≥8.3 µg/mL (upper 20th percentile), with 28.8 major bleedings/100 person-years (95% CI: 13.7–60.4). Patients with D-dimer ≥8.3 µg/mL had a 2.6-fold (95% CI: 1.1–6.6) higher risk of major bleeding than patients with D-dimer ≤2.3 µg/mL (lower 40th percentile). Major bleeding risk according to D-dimer ≥8.3 versus ≤2.3 µg/mL was particularly pronounced among those with deep vein thrombosis (HR: 4.6, 95% CI: 1.3–16.2) and provoked events (HR: 4.2, 95% CI: 1.0–16.8). In conclusion, our results suggest that D-dimer measured at diagnosis may serve as a predictive biomarker of major bleeding after VTE, especially within the initial 3 months.

Oral anticoagulation among atrial fibrillation patients with anaemia: an observational cohort study

2019 ◽  
Vol 40 (46) ◽  
pp. 3782-3790 ◽  
Author(s):  
Anders Nissen Bonde ◽  
Paul Blanche ◽  
Laila Staerk ◽  
Thomas Alexander Gerds ◽  
Anna Gundlund ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Cox Regression ◽  
Absolute Risk ◽  
Vitamin K Antagonists ◽  
Severe Anaemia ◽  
Hazard Ratios ◽  
Increased Risk ◽  
Mild Anaemia

Abstract Aims To investigate the risk of stroke/thromboembolism (TE) and major bleeding associated with anaemia among patients with atrial fibrillation (AF). Also, to assess the effects of oral anticoagulation (OAC) and time in therapeutic range (TTR) with vitamin K antagonists according to level of haemoglobin (Hb). Methods and results Through administrative registry databases, we identified all Danish patients diagnosed with AF from 1997 to 2012. We included 18 734 AF patients with recent available data on Hb. Multiple Cox regression analyses were used to estimate hazard ratios and to compute standardized absolute 1-year risks of stroke/TE and major bleeding. Among included patients, 3796 (20%) had mild anaemia (Hb 6.83–7.45 mmol/L for women and Hb 6.83–8.03 mmol/L for men) and 2562 (14%) had moderate/severe anaemia (Hb &lt;6.83 mmol/L). Moderate/severe anaemia was associated with increased risk of major bleeding and 9.1% lower median TTR compared with no anaemia. Use of OAC was associated with reduced risk of stroke/TE among patients without anaemia [standardized absolute 1-year difference −2.5%, 95% confidence interval (CI) −3.8 to −1.7%] or with mild anaemia (−2.3%, 95% CI −2.8 to −1.8%), but not with moderate/severe anaemia, (0.03%, −1.8 to +2.8%, interaction P = 0.01). Oral anticoagulation was associated with a 5.3% (95% CI 2.1–8.7%) increased standardized absolute risk of major bleeding among AF patients with moderate/severe anaemia. Conclusion Anaemia was common in patients with AF and associated with major bleeding and lower TTR. Oral anticoagulation was associated with more major bleeding, but no reduction in risk of stroke/TE among AF patients with moderate/severe anaemia.

Preventing Stroke in Patients with Atrial Fibrillation - Evidence Update for Clinicians

2020 ◽  
Author(s):  
Keyword(s):  
Atrial Fibrillation ◽  
General Population ◽  
Major Bleeding ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Administration Regimen ◽  
Increased Risk ◽  
All Cause Mortality

Patients with atrial fibrillation have a higher risk for stroke than the general population, and that risk increases markedly with age. Anticoagulation therapy lowers the risk of stroke and improves all-cause mortality. Warfarin has been the mainstay of anticoagulation therapy for decades but has an increased risk of major bleeding and requires a complicated administration regimen. A recent update of research adds to the evidence about the relative benefits and harms of newer anticoagulation therapies and tools to predict stroke related to atrial fibrillation and bleeding risk. This evidence on the newer therapies, along with recently updated guidelines on managing nonvalvular atrial fibrillation, can help inform clinician and patient decisions on anticoagulant use and may potentially reduce the risk of stroke and its consequences.

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