Veronica Ashton

Is Rivaroxaban Associated With Shorter Hospital Stays and Reduced Costs Versus Parenteral Bridging to Warfarin Among Patients With Pulmonary Embolism

Objective: We sought to compare the length of stay (LOS) and total costs for patients with pulmonary embolism (PE) treated with either rivaroxaban or parenterally bridged warfarin. Methods: This retrospective claims analysis was performed in the Premier Database from November 2012 to March 2015. Adult patients were included if they had a hospital encounter for PE (an International Classification of Diseases, Ninth Revision code = 415.1×) in the primary position, a claim for ≥1 diagnostic test for PE on day 0 to 2, and initiated rivaroxaban or parenteral anticoagulation/warfarin. Rivaroxaban users (allowing ≤2 days of prior parenteral therapy) were 1:1 propensity score matched to patients receiving parenterally bridged warfarin. Length of stay, total costs, and readmission for venous thromboembolism (VTE) or major bleeding during the same or subsequent 2 months following the index event were compared between cohorts. Analysis restricted to patients with low-risk PE was also performed. Results: Characteristics of the matched PE cohorts (n = 3466 per treatment) were well balanced. Rivaroxaban use was associated with a 1.36-day shorter LOS and

Adherence to Rivaroxaban Compared with Other Oral Anticoagulant Agents Among Patients with Nonvalvular Atrial Fibrillation

2304 reduction in total costs compared to parenterally bridged warfarin (P < .001 for both). Rates of readmission for VTE were similar between cohorts (1.7% vs 1.6%; P = .64). No difference was observed between treatments for readmission for major bleeding (0.2% vs 0.2%; P > .99). In analyses restricted to low-risk patients (n = 1551 per treatment), rivaroxaban was associated with a 1.01-day and a

Importance of balancing follow-up time and impact of oral-anticoagulant users’ selection when evaluating medication adherence in atrial fibrillation patients treated with rivaroxaban and apixaban

1855 reduction in LOS and costs, respectively (P < .001 for both). Rates of readmission were again similar between treatments (P > .56 for all). Conclusion: Rivaroxaban significantly reduced hospital LOS and costs compared to parenterally bridged warfarin, without increasing the risk of readmission.

Shortened hospital length of stay and lower costs associated with rivaroxaban in patients with pulmonary embolism managed as observation status

BACKGROUND Adherence to oral anticoagulant (OAC) agents is important for patients with nonvalvular atrial fibrillation (NVAF) to prevent potentially severe adverse events. OBJECTIVE To compare real-world adherence rates and time to discontinuation for rivaroxaban versus other OACs (apixaban, dabigatran, and warfarin) among patients with NVAF using claims-based data. METHODS Health care claims from the IMS Health Real-World Data Adjudicated Claims database (July 2012-June 2015) were analyzed. Adherence rate was defined as the percentage of patients with proportion of days covered (PDC) ≥ 0.80 and ≥ 0.90. Discontinuation was defined as a gap of more than 30 days between the end of a dispensing days of supply and the start date of the next fill, if any. Patients were included if they had ≥ 2 dispensings of rivaroxaban, apixaban, dabigatran, or warfarin at least 180 days apart (the first was considered the index date), had > 60 days of supply, had ≥ 6 months of pre-index eligibility, had ≥ 1 atrial fibrillation (AF) diagnosis pre-index or at index date, and had no valvular involvement. A logistic regression model was used to evaluate adherence to OAC therapy, while a Cox model was used to compare time to discontinuation; both models adjusted for baseline confounders. RESULTS A total of 13,645 rivaroxaban, 6,304 apixaban, 3,360 dabigatran, and 13,366 warfarin patients were identified. A significantly higher proportion of rivaroxaban users (80.1%) was adherent to therapy (PDC ≥ 0.80 at 6 months) versus apixaban (75.8%), dabigatran (69.2%), and warfarin users (64.5%). After adjustment, the proportion of patients adherent to therapy remained significantly higher for rivaroxaban users versus apixaban (absolute difference [AD] = 5.8%), dabigatran (AD = 9.5%), and warfarin users (AD = 13.6%; all P < 0.001). More pronounced differences were found with a PDC ≥0.90. In addition, rivaroxaban users were significantly less likely to discontinue therapy compared with other OACs after adjustments (all P < 0.05). CONCLUSIONS Among NVAF patients, rivaroxaban was associated with significantly higher adherence rates relative to other OACs whether using either a PDC of > 0.80 or > 0.90. Such differences in adherence could translate into improved patient outcomes and lower health care costs. DISCLOSURES This research was funded by Janssen Scientific Affairs. Ashton, Crivera, and Schein are employees and stockholders of Janssen Scientific Affairs. Laliberté, Germain, Wynant, and Lefebvre are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs in connection with this study. McHorney is an employee of Evidera, a consulting company that received research grants from Janssen Scientific Affairs in connection with this study. Peterson received research grants from Janssen Scientific Affairs in connection with this study. All authors contributed to concept and design. The data were collected by Germain, Wynant, Laliberté, and Lefebvre and interpreted primarily by McHorney and Peterson, with the assistance of Lefebvre, Laliberté, Ashton, Crivera, and Schein. The manuscript was written primarily by Laliberté, Germain, and Lefebvre, with the assistance of Wynant. Revisions were made primarily by Ashton, Crivera, McHorney, Schein, and Peterson.

Impact of renal function on ischemic stroke and major bleeding rates in nonvalvular atrial fibrillation patients treated with warfarin or rivaroxaban: a retrospective cohort study using real-world evidence

Abstract Objective: Studies comparing medications adherence have become common yet they often do not account for differences in relative follow-up. Patient selection criteria may impact validity and comparability of these studies as well. Methods: Adults with non-valvular atrial fibrillation, ≥1 rivaroxaban or apixaban dispensing (index date), and ≥1 year of pre-index eligibility were selected from IMS Health Real World Data Adjudicated Claims (IMS RWD Adjudicated Claims) and Truven Health MarketScan Research (Truven MarketScan) databases. Adherence was evaluated using proportion of days covered (PDC) ≥ 0.8 for treatment cohorts: (1) unmatched, with different follow-up, (2) propensity-score matched with similar follow-up, (3) matched, with similar follow-up and ≥2 rivaroxaban or apixaban dispensings, and (4) matched, with similar follow-up and chronic medication users only. Robustness was verified with PDC ≥0.9. Results: In the IMS RWD Adjudicated Claims database, rivaroxaban users had a longer mean follow-up than apixaban users (408 versus 254 days, respectively; p < .01). While crude comparisons demonstrated lower adherence rates for rivaroxaban than apixaban (−12.4 percentage points [pp]; p < .05), these difference attenuated after matching and (1) balancing follow-up (−2.2 pp; p < .05), (2) excluding single-time medication users (0.2 pp; p > .05), and reversed after (3) excluding non-chronic medication users (5.0 pp; p < .05). Results obtained were consistent when these analyses were repeated within the Truven MarketScan databases and when using a PDC ≥0.9. Conclusion: Medication adherence comparisons need to account for differences in follow-up. Selection of chronic medication users may impact comparative adherence advantage between medications.

Risk for Venous Thromboembolism Recurrence Among Rivaroxaban-treated Patients Who Continued Versus Discontinued Therapy: Analyses Among Patients with VTE☆

Unlike rivaroxaban, treatment of patients with pulmonary embolism (PE) with warfarin requires parenteral bridging and coagulation monitoring that may prolong length‐of‐stay (LOS) and increase hospital costs.

Outcomes associated with observation status versus inpatient management of pulmonary embolism patients anticoagulated with rivaroxaban

Abstract Objectives: Renal dysfunction is associated with increased risk of cardiovascular disease and is an independent predictor of stroke and systemic embolism. Nonvalvular atrial fibrillation (NVAF) patients with renal dysfunction may face a particularly high risk of thromboembolism and bleeding. The current retrospective cohort study was designed to assess the impact of renal function on ischemic stroke and major bleeding rates in NVAF patients in the real-world setting (outside a clinical trial). Methods: Medical claims and Electronic Health Records were retrieved retrospectively from Optum’s Integrated Claims–Clinical de-identified dataset from May 2011 to August 2014. Patients with NVAF treated with warfarin (2468) or rivaroxaban (1290) were selected. Each treatment cohort was stratified by baseline estimated creatinine clearance (eCrCl) levels. Confounding adjustments were made using inverse probability of treatment weights (IPTWs). Incidence rates and hazard ratios of ischemic stroke and major bleeding events were calculated for both cohorts. Results: Overall, patients treated with rivaroxaban had an ischemic stroke incidence rate of 1.9 per 100 person-years (PY) while patients treated with warfarin had a rate of 4.2 per 100 PY (HR = 0.41 [0.21–0.80], p = .009). Rivaroxaban patients with an eCrCl below 50 mL/min (N = 229) had an ischemic stroke rate of 0.8 per 100 PY, while the rate for the warfarin cohort (N = 647) was 6.0 per 100 PY (HR = 0.09 [0.01–0.72], p = .02). For the other renal function levels (i.e. eCrCl 50–80 and ≥80 mL/min) HRs indicated no statistically significant differences in ischemic stroke risks. Bleeding events did not differ significantly between cohorts stratified by renal function. Conclusions: Ischemic stroke rates were significantly lower in the overall NVAF population for rivaroxaban vs. warfarin users, including patients with eCrCl below 50 mL/min. For all renal function groups, major bleeding risks were not statistically different between treatment groups.

Outcomes related to variation in hospital pulmonary embolus observation stay utilization.

PURPOSE The EINSTEIN-Extension trial showed that an extended rivaroxaban treatment significantly reduced the risk for venous thromboembolic (VTE) recurrence. The present study assessed the risk for VTE recurrence and major bleeding associated with extended rivaroxaban treatment in a clinical practice setting among patients with VTE. METHODS A retrospective study was conducted using claims data from February 2011 to April 2015. It included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and who continuously used rivaroxaban for at least 3 months (index date: end of initial 3-month treatment). Categorized into discontinued and continued cohorts, patients were followed up from the index date until the end of continuous treatment (continued cohort) or end of data or reinitiation of oral anticoagulant therapy (discontinued cohort). Using inverse probability of treatment weights controlling for confounders, adjusted Kaplan-Meier rates of recurrent VTE and major bleeding events were compared. FINDINGS The analysis showed that, compared with the discontinued cohort (n = 1,536), the continued cohort (n = 5,933) had a significantly lower VTE recurrence rate after an additional 3 months (0.70% vs 1.70%), 6 months (1.41% vs 2.34%), 9 months (1.82% vs 3.01%), and 12 months (1.97% vs 3.01%) of treatment (all, p < 0.05). The difference in the cumulative event rates for major bleeding was not statistically significant. Similar results were obtained in an analysis among patients with VTE receiving rivaroxaban for ≥6 months. IMPLICATIONS Our results suggest that, in clinical practice settings, patients with VTE who continued rivaroxaban therapy after the initial 3- or 6-month treatment period had a significantly lower risk for VTE recurrence without a statistically significant increased risk for major bleeding.

External Validation of the Multivariable ‘In-Hospital Mortality for Pulmonary Embolism Using Claims Data’ Prediction Rule in the Premier Hospital Database

Please cite this article as: Weeda Erin R., Wells Philip S., Peacock W. Frank, Fermann Gregory J., Baugh Christopher W., Ashton Veronica, Crivera Concetta, Wildgoose Peter, Schein Jeff R., Coleman Craig I., Outcomes Associated with Observation Status versus Inpatient Management of Pulmonary Embolism Patients Anticoagulated with Rivaroxaban, International Journal of Cardiology (2016), doi: 10.1016/j.ijcard.2016.08.126

Cost comparison of continued anticoagulation with rivaroxaban versus placebo based on the 1-year EINSTEIN-Extension trial efficacy and safety results

ABSTRACT Objectives: To characterize hospital variation in use of observation stays to manage pulmonary embolism (PE) and its association with subsequent outcomes. Methods: We performed a cross-sectional study of hospitals reporting ≥75 PE encounters (emergency department, observation stay or inpatient admission) using Premier data from 11/2012-3/2015. We included hospital encounters for adults with a primary diagnosis of PE (415.1x), ≥1 diagnostic test claim for PE on day 0-2 and evidence of PE treatment. Hospitals were divided into tertiles (Ts) based on the proportion of all PE encounters managed as an observation stay. The association between observation stay utilization and the proportion of PE encounters resulting in in-hospital death or re-admission within the same or subsequent 2-months were compared across Ts using a generalized estimating equation adjusted for individual encounter disease severity. Results: Observation PE management increased over the study period (1.9%-5.4%; Pearson’s r = 0.88, p < 0.001). Of all hospitals reporting ≥1 PE encounter, 255 had ≥75 encounters (representing a total of 38,172 PE encounters) and were included in the analysis. Individual hospital observation use for PE management varied from 0%-33.9%. Mean hospital rates of PE observation stay by T were T1 = 0.1%, T2 = 2.2% and T3 = 7.9%. Hospitals that used observation stays most frequently (T3) were more likely in the South or Mid-west (p < 0.001), to be a teaching hospital (p = 0.03) and less likely to serve an urban population (p = 0.02). Hospitals in T3 (n = 11,780 encounters) were not associated with a statistically significant increased risk of in-hospital death (2.3% vs. 2.1%-2.6%) or all-cause (4.7% vs. 5.1%-5.4%), venous thromboembolism-(1.4% vs. 1.8%-2.0%) or major bleeding (0.3% vs. 0.2-0.3%)-related re-admission in the same or subsequent 2-months compared to T1 (n = 12,940 encounters) and T2 (n = 13,452 encounters). Conclusion: PE management via observation stays has increased over recent years. Hospitals more frequently utilizing observation stays may not experience increased negative outcomes, such as re-admission.