Abstract 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database
Jiang HeLloyd HaskellJeffrey S. BergerVeronica AshtonFrançois LalibertéConcetta CriveraKip BrownPatrick LefèbvreJeffrey Schein
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Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.Keywords:
Stroke
Thromboembolic stroke
Currently, several newer oral anticoagulants namely dabigatran (anti-IIa), rivaroxaban (anti-Xa), and apixaban are available for various clinical implications. Another oral anti-Xa edoxaban is under development. A parenteral anti-Xa drug namely otamixaban is also under development for cardiovascular interventions. Bleeding complications have been reported in the new oral anticoagulants and have been managed by conventional approaches with limited success. Prothrombin complex concentrates (PCCs) are reported to neutralize the anticoagulant activity of these agents. The PCCs are also able to generate endogenous factor Xa and IIa along with other proteases that are capable of neutralizing the circulating anti-Xa or anti-IIa activities of the newer anticoagulants. The generation of Xa and IIa is also dependent on the type of tissue factor available for their activation. These reported studies suggest that different tissue factors differentially activate a PCC namely Profilnine SD. Furthermore, dabigatran differs from rivaroxaban and other factor Xa inhibitors in its inhibitory profile.
Apixaban
Edoxaban
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Risk of Gastrointestinal Bleeding with Dabigatran: A Head-to-Head Comparative Study with Rivaroxaban
Introduction: The risk of gastrointestinal (GI) bleeding of dabigatran and rivaroxaban is relatively unexplored. The aim of our study was to compare this risk in both drugs. Methods: We examined the medical records of patients on either dabigatran or rivaroxaban from October 2010 to April 2013 in two hospitals. Results: A total of 374 patients (147 rivaroxaban vs. 227 dabigatran) were identified. GI bleeding occurred in 5.3% in the dabigatran when compared to 4.8% in the rivaroxaban group (p = 0.8215). Multivariate analysis showed that the odds of GI bleeding while on dabigatran for ≤40 days when compared to ≥40 days was 8.3 (p < 0.0001). In the rivaroxaban group, patients who were on the drug for ≤40 days had a higher incidence of bleeding when compared to those >40 days (OR = 2.8, p = 0.023). Concomitant use of antiplatelets (single or dual) or non-steroidal anti-inflammatory drugs was not associated with increased bleeding in the dabigatran group; however, the use of dual antiplatelet agents with rivaroxaban was associated with an increased risk of GI bleeding (OR = 7.4, p = 0.0378). Prior GI bleeding had a higher risk of bleeding in the rivaroxaban group (OR = 15.5, p = 0.0002). Conclusion: Dabigatran was not associated with a higher incidence of GI bleeding. Both drugs had a higher bleeding risk in the first 40 days.
Gastrointestinal bleeding
Concomitant
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Apixaban
Edoxaban
Stroke
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To assess persistence and adherence to rivaroxaban, dabigatran, and vitamin K antagonist (VKA) treatment in primary care patients with non-valvular atrial fibrillation (AF) newly starting anticoagulant therapy. Prescription data for oral anticoagulants were obtained from 7265 eligible patients from primary care practices across Germany. Persistence with and adherence to anticoagulation were assessed in anticoagulant-naïve patients with AF newly treated with dabigatran, rivaroxaban, or VKA during follow-up periods of at least 180 days, respectively 360 days after the prescription date. Persistence probabilities after 180 days were 66.0% for rivaroxaban, 60.3% for dabigatran, and 58.1% for VKA (P < 0.001 for rivaroxaban vs. VKA and P = 0.008 for rivaroxaban vs. dabigatran). After 360 days, persistence probabilities were 53.1, 47.3, and 25.5%, respectively (P < 0.001 for rivaroxaban and dabigatran vs. VKA). Considering the development over 360 days rivaroxaban demonstrated a better persistence compared with dabigatran (P = 0.026). Male gender and the presence of diabetes mellitus were associated with increased persistence, while renal impairment and antiplatelet drug use decreased persistence. High adherence (MPR ≥0.80) was observed in 61.4% of rivaroxaban users and in 49.5% of dabigatran users, with means of 0.76 [95% confidence interval (CI) 0.74–0.78] for rivaroxaban and 0.67 (95% CI 0.65–0.69) for dabigatran (P < 0.001). Rivaroxaban and dabigatran demonstrated better persistence than VKA at Day 360. Furthermore, rivaroxaban was associated with better persistence and adherence than dabigatran. Further studies are needed to identify factors responsible for this difference and evaluate the impact on outcomes.
Vitamin K antagonist
Persistence (discontinuity)
Stroke
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Discontinuation
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Apixaban
Stroke
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