Effectiveness and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and coronary or peripheral artery disease

2019 ◽  
Vol 6 (3) ◽  
pp. 159-166 ◽  
Author(s):  
Craig I Coleman ◽  
William L Baker ◽  
Anna-Katharina Meinecke ◽  
Daniel Eriksson ◽  
Brandon K Martinez ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Peripheral Artery Disease ◽  
Major Bleeding ◽  
Cox Regression ◽  
Data Availability ◽  
Routine Practice ◽  
Peripheral Artery ◽  
Vascular Events ◽  
Significant Difference ◽  
Artery Disease

Abstract Aims There are scarce data evaluating the effectiveness and safety of rivaroxaban vs. warfarin in non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD) and/or peripheral artery disease (PAD) treated in routine practice. Methods and results Using MarketScan data from January 2012 to December 2017, we identified oral anticoagulant (OAC)-naïve NVAF patients receiving rivaroxaban (15–20 mg once daily) or warfarin, 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). Endpoints included a composite of major thrombotic vascular events (MTVEs) (including ischaemic stroke, myocardial infarction, or need for lower limb revascularization/major amputation) and major bleeding. Patients were followed until an event-of-interest, discontinuation/switch of index OAC, insurance disenrolment, or end-of-data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox regression. We identified 3257 rivaroxaban (30.4% received a 15 mg dose) and 5046 warfarin users with NVAF and comorbid CAD and/or PAD. Rivaroxaban was associated with a 32% (95% CI = 8–50%) reduction in the composite of MTVE. No significant difference in major bleeding was observed (HR = 1.13, 95% CI = 0.84–1.52). No statistical interactions were noted in subgroup analyses performed on the MTVE (P-interaction ≥ 0.35 for all) or major bleeding endpoints (P-interaction ≥ 0.09 for all). Conclusion Among patients with NVAF and comorbid CAD and/or PAD, rivaroxaban use was associated with a reduced risk of MTVEs vs. warfarin, without significantly increasing major bleeding risk.

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

scholarly journals Angiogenin—A Proposed Biomarker for Cardiovascular Disease—Is Not Associated With Long-Term Survival in Patients With Peripheral Artery Disease

Angiology ◽  
2021 ◽  
pp. 000331972110043
Author(s):  
Clemens Höbaus ◽  
Gerfried Pesau ◽  
Bernhard Zierfuss ◽  
Renate Koppensteiner ◽  
Gerit-Holger Schernthaner
Keyword(s):  
Peripheral Artery Disease ◽  
Cox Regression ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Cross Sectional Study ◽  
Enzyme Linked Immunosorbent Assay ◽  
Peripheral Artery ◽  
Cross Sectional ◽  
Term Survival ◽  
Artery Disease

We evaluated angiogenin as a prospective biomarker in peripheral artery disease (PAD) patients with and without claudication symptoms. A pilot study suggested an elevation of angiogenin in critical limb ischemia. However, in PAD patients, the predictive value of angiogenin has not yet been evaluated. For this purpose, 342 patients with PAD (age: 69 ± 10 years, 34.5% women) were followed-up for 7 years in a cross-sectional study. Angiogenin was measured by enzyme-linked immunosorbent assay. All-cause and cardiovascular mortality were analyzed by Cox regression. Angiogenin levels were higher in men ( P = .001) and were associated with patient waist-to-hip ratio ( P < .001), fasting triglycerides ( P = .011), and inversely with estimated glomerular filtration rate ( P = .009). However, angiogenin showed no association with age, characteristics of diabetes, markers of lipid metabolism, or C-reactive protein. Angiogenin did not correlate with markers of angiogenesis such as vascular endothelial growth factor, angiopoietin-2, or tie-2. Furthermore, angiogenin was not associated with PAD Fontaine stages or with patient ankle-brachial index in addition to all-cause mortality (hazard ratio [HR] = 1.09 [95% CI: 0.89-1.34]) or cardiovascular morality (HR = 1.05 [0.82-1.35]). These results suggest that angiogenin does not provide further information regarding outcome prediction in patients with PAD.

Abstract 13342: Patient Demographics, Clinical Characteristics, Medication Utilization, Medical Resource Use and Outcomes Associated with Patients with Symptomatic Peripheral Artery Disease

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Monica Reed Chase ◽  
Prakash Navaratnam ◽  
Howard Friedman ◽  
Kim Heithoff ◽  
Ross J Simpson
Keyword(s):  
Peripheral Artery Disease ◽  
Clinical Characteristics ◽  
Limb Amputation ◽  
Bleeding Complications ◽  
Medical Resource ◽  
Peripheral Artery ◽  
Vascular Events ◽  
Patient Demographics ◽  
Medication Utilization ◽  
Artery Disease

Background: Symptomatic peripheral artery disease (SPAD) [defined as intermittent claudication (IC) and/or critical limb ischemia requiring peripheral revascularization (PRV)] is associated with significant CV and PAD-related morbidity and mortality. However, the real world impact of SPAD has not been well characterized to date. Methods: An algorithm that selectively identifies SPAD patients using a combination of PAD related ICD-9 diagnostic and DRG codes, PRV CPT-4 procedure codes, and IC medication NDC codes was used to select study eligible patients from the MarketScan Commercial and Encounters database from 01/01/06 to 06/30/10. The earliest date of a record of SPAD was the index date and a period of 1 year pre- and 3 years post-index was the study time frame. Patients with stroke/TIA, with bleeding complications and contraindications to anti-platelet therapy were excluded. Descriptive statistics comparing patient demographics, clinical characteristics, medication utilization, medical resource utilization and outcomes (event risk estimates for MI, any stroke, revascularization (coronary and peripheral), limb amputation, acute ischemic event hospitalizations and costs) were generated. Results: A total of 16,663 patients (58.0% male; mean age (± SD) 67.2 ± 12.9 years) were identified with SPAD. SPAD patients had significant comorbidities with 31.5% CAD, 36.0% diabetes, 31.0% hyperlipidemia and 53.1% hypertension. Twenty percent (20%) of SPAD patients were on clopidogrel in the pre-index. Pre-index use of beta-blocker, ACE, ARB and statin use was 42.1%, 37.1%, 21.1% and 48.5% respectively. SPAD patients experienced CV events such as any stroke (8.9%), NSTEMI (4.1%), STEMI (4.8%) and UA (7.5%) in the post-index. SPAD patients also experienced a limb amputation (11.5%), endovascular PRV (17%), and open PRV (14.6%) in the post-index. Annualized SPAD-related hospitalization rates, inpatient costs and outpatients costs were significantly higher in the post-index (0.1 vs 0.01, $2,073 vs $175, $1,313 vs $936; all p<0.0001). Conclusion: In an insured population, SPAD patients have low utilization of preventive medications, high rates of major vascular events (both CV and PAD related) and high costs.

Peripheral artery disease and clinical outcomes in patients with atrial fibrillation: A report from the FANTASIIA registry

2020 ◽  
Author(s):  
Vicente Bertomeu‐Gonzalez ◽  
José Moreno‐Arribas ◽  
María Asunción Esteve‐Pastor ◽  
Inmaculada Roldán‐Rabadán ◽  
Javier Muñiz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Peripheral Artery Disease ◽  
Peripheral Artery ◽  
Artery Disease

P1960Endothelial progenitor cells are associated with cardiovascular outcome in patients with peripheral artery disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Pesau ◽  
C Hoebaus ◽  
B Zierfuss ◽  
R Koppensteiner ◽  
G H Schernthaner
Keyword(s):  
Progenitor Cells ◽  
Peripheral Artery Disease ◽  
Cardiovascular Mortality ◽  
Cox Regression ◽  
Smoking Status ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Peripheral Artery ◽  
Kaplan Meier ◽  
Artery Disease

Abstract Background and introduction Endothelial dysfunction and associated cells are an important cornerstone in the development and progression of peripheral artery disease (PAD). Endothelial progenitor cells (EPC) are released from the bone marrow and have exhibited the potential for cardiovascular repair. Higher EPC levels have been linked to longer event-free survival in coronary artery disease. Similar evaluation of EPC on mortality in PAD is lacking. Purpose The current study aimed to evaluate the possible association between EPC levels and mortality in PAD patients. Methods EPC were measured in 367 PAD patients (age 69.22±10.3, 66.5% male, Fontaine stage I-II) by flow cytometry using the cell surface marker CD34+ and CD309+. Patients were followed for seven years to assess all cause and cardiovascular mortality. Patients were categorized into quartiles according to EPC levels for further analyses. Statistics included Kaplan-Meier and Cox regression. Results 89 patients died over the observation period. ICD-codes indicated a cardiovascular cause in 58 patients. The group with the highest count of EPC showed a trend towards higher all-cause mortality (p=0.070) and a significant association with cardiovascular mortality (p=0.002). Multivariable adjustment for age, c-reactive protein, systolic blood pressure, renal function (creatinine and urinary albumin), low density lipoprotein cholesterol, HbA1c, and smoking status revealed the EPC quartile to be an independent risk factor for cardiovascular mortality (p=0.016). Conclusion Increased levels of CD34+CD309+ cells are independently associated with long-term cardiovascular mortality in PAD patients.

Non-vitamin K antagonist oral anticoagulants and warfarin in atrial fibrillation patients with concomitant peripheral artery disease

2019 ◽  
Author(s):  
Hsin-Fu Lee ◽  
Lai-Chu See ◽  
Pei-Ru Li ◽  
Jia-Rou Liu ◽  
Tze-Fan Chao ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Vitamin K ◽  
Major Bleeding ◽  
Lower Limb ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Peripheral Artery ◽  
Artery Disease

Abstract Aims  To investigate the effectiveness, safety, and outcomes of lower limb events for non-vitamin K antagonist oral anticoagulants (NOACs) vs. warfarin among atrial fibrillation (AF) patients with concomitant peripheral artery disease (PAD). Methods and results In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, a total of 5768 and 2034 consecutive AF patients with PAD patients taking NOACs or warfarin were identified from 1 June 2012 to 31 December 2017, respectively. We used propensity score stabilized weighting to balance covariates across study groups. In the cohort, there were 89% patients were taking low-dose NOAC (dabigatran 110 mg twice daily, rivaroxaban 10–15 mg daily, apixaban 2.5 mg twice daily, or edoxaban 30 mg daily). Non-vitamin K antagonist oral anticoagulant was associated with a comparable risk of ischaemic stroke, and a lower risk of acute myocardial infarction [hazard ratio (HR): 0.61, 95% confidence interval (CI): 0.42–0.87; P = 0.007], lower extremity thromboembolism (HR: 0.56, 95% CI: 0.44–0.72; P &lt; 0.0001), revascularization procedure (HR: 0.58, 95% CI: 0.47–0.72; P &lt; 0.0001), lower limb amputation (HR: 0.32, 95% CI: 0.23–0.46; P &lt; 0.0001), and all major bleeding (HR: 0.64, 95% CI: 0.50–0.80; P = 0.0001) than warfarin after weighting. The advantage of NOACs over warfarin persisted in high-risk subgroups including patients of ≥75 years of age, diabetes, renal impairment, or use of concomitant antiplatelet agent. Conclusion  This population-based study indicated that NOACs were associated with a comparable risk of ischaemic stroke, and a significantly lower risk of major adverse limb events and major bleeding than warfarin among AF patients with concomitant PAD. Therefore, thromboprophylaxis with NOACs may be considered for such patients.

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