ALBERT

Description: Introduction: Therapeutic options for the management of venous thromboembolism (VTE) in patients with cancer remain limited. Guidelines recommend anticoagulation with low molecular weight heparin (LMWH) monotherapy for ≥3-6 months, and possibly indefinitely, for patients with active cancer. However, drug cost and patient preference issues may lead to non-compliance with these recommendations. The objective of this study is to describe current treatment patterns and to evaluate patient persistence on various anticoagulants. Methods: Medical and pharmacy claims from the Humana Database were analyzed. To reflect recent treatment patterns, the study population was restricted to patients who had their first VTE between 1/1/2013 and 12/31/2014. Newly diagnosed cancer patients with a first VTE diagnosis (deep vein thrombosis [DVT] or pulmonary embolism [PE]) occurring after their first cancer diagnosis (a 30-day window before the cancer diagnosis was allowed), and with ≥1 dispensing of an anticoagulant agent within 30 days after their VTE diagnosis, were selected. Based on the first anticoagulant agent received, patients were classified into one of the following cohorts: LMWH, LMWH/warfarin, warfarin and rivaroxaban. Use of other anticoagulants including fondaparinux, heparin, apixaban, or dabigatran was low and could not be analyzed due to small sample size. The observation period spanned from the date of the first anticoagulant dispensing to the end of insurance eligibility or the end of data availability, whichever occurred earlier. Discontinuation of the index therapy was defined by a time gap without refill of the index anticoagulant for more than 60 days after the presumed exhaustion of the last known dispensing. For patients in the LMWH/warfarin group, the 2 medications were filled simultaneously as an index therapy, with the expectation that the patients were bridged to warfarin; therefore, their persistence was evaluated based on warfarin therapy. Persistence on therapy was assessed for 12 months using Kaplan-Meier rates, and unadjusted Cox proportional hazards models were used to compare the time to discontinuation between cohorts. Results: A total of 2,941 newly diagnosed patients with cancer who developed VTE and received anticoagulation in outpatient settings were identified. Of these, 97% received anticoagulation with either LMWH (n=735; 25%), LMWH/warfarin (n=550; 18.7%), warfarin (n=853; 29%), rivaroxaban (n=709; 24.1%). Mean age and gender were similar across treatment cohorts. Approximately 90% of the patients had diagnoses of solid tumors. Diagnoses for DVT, PE, and DVT/PE were 55%, 27%, and 18%, respectively, and were similar across cohorts. Treatments for cancers associated with very high VTE risk (stomach, pancreas, and brain) ranged from 15% in LMWH to 6% in rivaroxaban cohorts, while high VTE risk (lung, lymphoma, gynecologic, bladder, testicular, and renal) ranged from 39% in LMWH to 30% in warfarin and LMWH/warfarin cohorts. Around 75% (warfarin) to 58% (rivaroxaban) of the VTE cases were diagnosed in inpatient settings. The median treatment durations for LMWH, LMWH/warfarin, warfarin, and rivaroxaban users were 3.29, 7.76, 8.12, and 7.92 months, respectively. Kaplan-Meier rates of persistence to the initial therapy were 37%, 60%, 62%, and 61% at 6 months, and 21%, 37%, 34%, and 36% and at 12 months for the LMWH, LMWH/warfarin, warfarin and rivaroxaban cohorts, respectively (Figure 1). LMWH/warfarin, warfarin, and rivaroxaban users were significantly more likely to remain on their initial therapy compared to LMWH, with hazard ratios (HRs; 95% CI) of 0.38 (0.32-0.45), 0.40 (0.34-0.46), and 0.42 (0.36-0.50), respectively (all p-values

Description: Abstract 2100 Poster Board II-77 Introduction: Anticoagulant therapy is recommended for preventing venous thromboembolism (VTE) among patients undergoing total knee arthroplasty (TKA). During warfarin therapy, monitoring of international normalized ratio (INR) is necessary to avoid underdosing (which can lead to VTE and associated events) or overdosing (which can lead to significant bleeding). The purpose of this project was to investigate the distribution of out-of-range INR results among warfarin-treated patients undergoing TKA. Patients and Methods: A retrospective cohort analysis was conducted using the MedMining® database of electronic medical record data. Data were obtained for patients with a TKA procedure and a prescription for warfarin issued within 3 days of surgery from January 1, 2004 through January 31, 2009. We identified INR results during warfarin therapy following surgery for up to 90 days. INR results were categorized as in therapeutic range (2–3), below range (〈 2), or above range (〉 3). For each patient, we calculated the proportion of INR results in each category. Time to first in-range INR was calculated as days from warfarin start to first in-range level for those with at least 1 in-range level. Results: Of 1801 eligible patients, 63.3% were aged 65 years and above, 62.7% were female, and 98.3% were White/Caucasian. The most common reason for surgery was osteoarthritis (96.6%) and the mean length of hospital stay was 3.6 days (SD, 1.4 days). Most patients (82.7%) had 2 or more INR levels during warfarin exposure; 44.2% had 5 or more INR values. Among the 1173 patients with at least 2 INR levels available, patients had a mean of 15.3% of INR values within therapeutic range, 82.9% of INR levels below the therapeutic range and 1.8% of values above range. A total of 52.8% of patients with at least 2 INR levels had no INR fall within the therapeutic range. The median time to first in-range INR was 7 days (range 1-90 days). Conclusions: This population-based observational study found poor warfarin anticoagulation control in TKA patients with only about half of patients having INRs within the therapeutic range. INR levels above the therapeutic range were rare, but many patients received insufficient doses of warfarin to achieve therapeutic INR levels. Among those who did achieve at least one in-range INR, the time to achieve this was long, exposing the patient to the risk of VTE during the highest post-op risk period (i.e., within the first7 days after surgery). It is possible surgeons are targeting sub therapeutic INR ranges or patients have poor adherence to warfarin therapy; the data do not permit an investigation of physicians' targets or whether patients took the medication as prescribed. These research findings may not be generalizable to the broader US population. A study of the consequences of INR values below the therapeutic range in the TKA population is warranted. Disclosures: Kachroo: United BioSource Corp: Employment; Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Nordstrom:United BioSource Corp: Employment; Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Nutescu:Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Schein:Ortho-McNeil Janssen Scientific Affairs, LLC: Employment. Bookhart:Ortho-McNeil Janssen Scientific Affairs, LLC: Employment, Equity Ownership.

Description: Background: The American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) disease recommend treatment with anticoagulation for at least 3 months in patients with VTE. Moreover, the EINSTEIN-extension study assessed the effect of rivaroxaban on the risk of VTE recurrences in patients who had completed 6 to 12 months of treatment for VTE. Results showed that rivaroxaban significantly reduced the risk of VTE recurrences with a small increased risk of major bleeding. The objective of this study was to assess the risk of VTE recurrences and major bleeding associated with extended rivaroxaban treatment in a real-world setting among all VTE patients (i.e., unprovoked, provoked, and cancer related). Methods: A retrospective study was conducted using Truven Health Analytics MarketScan Databases from 02/2011 to 04/2015. The study included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and continuously used rivaroxaban for at least 3 months. The end of the initial 3-month rivaroxaban treatment was defined as the index date and patients were categorized into discontinued (treatment ended) and continued cohorts. Patients were followed from index date until end of continuous treatment for the continued cohort or end of data or re-initiation of oral anticoagulant therapy for the discontinued cohort. The outcomes included VTE recurrences identified as a primary diagnosis documented during a hospitalization and major bleeding events identified by a validated algorithm (Cunningham et al., 2011). Kaplan-Meier rates for VTE recurrences and major bleeding events at 3, 6, 9, and 12 months after the index date were compared between cohorts with adjustment for baseline confounding using the inverse probability of treatment weights (IPTW) method based on propensity score. Patients with unprovoked VTEs, defined as not having recent surgery, cancer, pregnancy or estrogen therapy, were also evaluated. Sample sizes of patients with provoked VTEs and cancer were too small to analyze these populations. A sensitivity analysis was also conducted among VTE patients receiving rivaroxaban for at least 6 months. Results: Among the 3-month treatment population, a total of 5,933 (63.4% unprovoked VTE) and 1,536 (68.4% unprovoked VTE) rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (SD) observation period was 149.3 (124.4) days in the continued cohort and 211.1 (191.6) days in the discontinued cohort. The Kaplan-Meier analysis (Figure 1) showed that patients in the continued cohort had significantly lower rates of VTE recurrences 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%; all p-values 〈 0.05) of treatment. No statistically significant differences in the cumulative event rates for major bleeding (Figure 2) were observed between the continued and the discontinued cohort at 3 months (0.58% vs. 0.82%), 6 months (0.91% vs. 0.88%), 9 months (1.33% vs. 1.18%), and 12 months (1.44% vs. 1.44%; all p-values 〉 0.05). Among the 6-month treatment population, a total of 2,676 (65.9% unprovoked VTE) and 1,127 (70.4% unprovoked VTE) rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (SD) observation period was 158.5 (130.6) days in the continued cohort and 206.5 (171.5) days in the discontinued cohort. Patients in the continued cohort had lower rates of VTE recurrences after an additional 3 months (0.82% vs. 1.41%), 6 months (1.22% vs. 2.69%), 9 months (1.35% vs. 3.02%), and 12 months (1.72% vs. 3.70%; except at 3 months all p-values 〈 0.05) of treatment. No differences in the cumulative event rates for major bleeding were observed between the continued and the discontinued cohorts. Similar results were found among patients with unprovoked VTE for the 3- and 6-month analyses. The interaction term between the cohort variable (Continued vs. Discontinued) and the type of VTE (unprovoked vs. other types of VTE) was non-significant in both populations (p-value 〉 0.05), which suggests that the benefit of extended treatment do not depend on the type of VTE events. Conclusions: Our study results suggest that all patients with VTE who continued rivaroxaban therapy after the first 3-month and 6-month treatment periods had significantly lower risk of VTE recurrences without an increased risk of major bleeding. Disclosures Khorana: Halozyme: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding. Berger:AZ: Research Funding; Merck: Membership on an entity's Board of Directors or advisory committees. Wells:BMS/Pfizer: Research Funding; Itreas: Other: Served on a Writing Committee; Janssen Pharmaceuticals: Consultancy; Bayer Healthcare: Other: Speaker Fees and Advisory Board. Seheult:Janssen Scientific Affairs, LLC: Consultancy. Ashton:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lejeune:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Wildgoose:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Kaatz:Bristol Myer Squibb: Honoraria; Pfizer: Honoraria; CSL Behring: Honoraria; Boehringer Ingelheim: Consultancy; Pfizer: Consultancy; Janssen: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Boehringer Ingelheim: Honoraria; Janssen: Honoraria.

Description: Background: Previous studies evaluating the simplified Pulmonary Embolism Severity Index (sPESI) for predicting pulmonary embolism (PE) mortality did not consistently report the timing of vital sign measurement (systolic blood pressure [SBP], heart rate [HR] and oxygen [O2] saturation) relative to the PE presentation. Objectives: To evaluate the impact of vital sign measurement timing on sPESI's ability to identify PE patients at low-risk for in-hospital all-cause mortality. Methods: This was a retrospective analysis of PE patients from a large, urban teaching hospital in the Northeastern United States. Consecutive patients, diagnosed with PE between November 2010 and May 2015, were identified using the institution's billing system. To be eligible for inclusion, patients had an International Classification of Diseases, ninth-revision, clinical modification (ICD-9-CM) code of 415.1x in the primary position. Those in whom PE could not be objectively confirmed via chart review and those receiving thrombolysis or embolectomy were excluded. Patients' first and either lowest (SBP, O2 saturation) or highest (HR) value within the first 24 hours from presentation (subsequently referred to as "least favorable" values) were recorded. We then compared sensitivity, specificity and negative predictive values (NPV) and 95% confidence intervals (CIs) and the ability of the sPESI to predict all-cause in-hospital mortality using the first and least favorable vital signs. Results: A total of 562 PE patients (18.9% 〉80 years of age, 28.5% history of cardiopulmonary disease, 29.5% history of cancer) were included and 2.1% died in-hospital. No differences in sPESI's sensitivity, specificity or NPV were observed when scored using the first or least favorable vital sign values. sPESI classified 169 (30.1%) as low-risk (sPESI=0) vs. 153 (27.2%) when the least favorable vital sign value was used. Conclusions: The sensitivity and NPV of sPESI to predict PE patients' risk for all-cause in-hospital mortality is not affected by the timing of vital sign measurement. Using the least favorable value within 24-hours of presentation does result in a smaller proportion of patients being classified as low-risk. Table 1.CharacteristicFirst% (95%CI)Least Favorable% (95%CI)P-valueSensitivity91.7 (59.8-99.6)91.7% (59.8-99.6)〉0.99Specificity30.5 (26.8-34.6)27.6% (24.0-31.6)0.31NPV99.4 (96.2-99.9)99.3% (95.9-99.9)0.94Proportion classified as low-risk, n (%)169 (30.1)153 (27.2)

Description: Introduction: Patients with cancer are not only at a high risk for developing primary but also recurrent venous thromboembolism (VTE). These events lead to increased burden of cancer management and healthcare costs. It was estimated that all-cause health care costs for cancer patients with VTE were $30,538/patient higher than in those without VTE (Khorana, 2013). To our knowledge, very little information exists on cost of VTE recurrence among cancer patients. The objective of this study was to analyze resource utilization and costs of patients with cancer experiencing a VTE recurrence using a large claims database. Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE recurrences were defined as hospitalizations with a primary diagnosis of VTE. Patients were classified into two groups: patients who experienced a VTE recurrence and patients who did not. Resource utilization and costs were evaluated for the entire follow up period, starting with the initiation of the anticoagulant therapy until whichever was earlier, end of eligibility or end of data. Healthcare resource utilization evaluated included number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. All-cause and VTE-related healthcare resource utilization was evaluated. Comparisons between patients with a VTE recurrence and patients without a VTE recurrence were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. All-cause and VTE-related healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference. Results: A total of 2,428 newly diagnosed cancer patients who developed VTE and were treated with anticoagulants were identified. Of these, 413 (17.1%) experienced recurrent VTE during the follow up period. Patients who developed recurrent VTE and those who did not were similar in terms of age, gender, race, and region. No statistically significant differences between groups were observed in Charlson comorbidity index or in selected comorbidities during the 6 month baseline period. However, more patients with recurrent VTE recurrence had their index VTE documented during a hospitalization (61.3% vs. 55.4%, p=0.03). Patients with a VTE recurrence had significantly more ER and outpatient visits at baseline compared to those without recurrence, but no statistically significant difference was observed in baseline total healthcare costs ($29,352 vs. $27,955, p=0.44, respectively). The mean follow-up was similar between groups: 9.6 months for patients experiencing a VTE recurrence and 9.3 months for patients without a VTE recurrence (p=0.4059). Patients with a VTE recurrence had higher all-cause resource utilization rates (RRs; 95% CI) compared to patients without a VTE recurrence (hospitalization [2.37; 2.23 - 2.52], hospitalization days [2.64; 2.57 - 2.72], ER visits [1.62; 1.48 - 1.76], and outpatient visits [1.26; 1.24 - 1.28]). The rates of VTE-related hospitalization and VTE-related hospitalization days were close to $30,000 higher in patients with a VTE recurrence (Figure 1). The all-cause healthcare costs were $84,708 PPPY in patients with a VTE recurrence compared to $44,903 in patients without a VTE recurrence. The difference was mainly explained by lower VTE-related hospitalization costs (Figure 2). Conclusion: This real-world claims analysis showed that cancer patients with recurrent VTE consume significantly more healthcare resources. Total healthcare costs were nearly 2-fold higher in cohort with than in cohort without VTE recurrence. Close to 75% of the total cost difference was associated with VTE recurrence. VTE-related costs were ~4-fold higher in cohort with than in cohort without VTE recurrence. Reducing VTE recurrence in patients with cancer could lead to substantial healthcare cost savings. Figure 1 VTE-Related Healthcare Resource Utilization Figure 1. VTE-Related Healthcare Resource Utilization Figure 2 VTE-Related Healthcare Costs, PPPY Figure 2. VTE-Related Healthcare Costs, PPPY Disclosures Khorana: Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock.

Description: Introduction: The standard of care for treatment of cancer-related venous thromboembolism (VTE) is a low molecular heparin (LMWH). In our previous claimsbased analysis, we showed that besides LMWH oral anticoagulants, warafrin and rivaroxaban are widely prescribed in clinical practice (Khorana, 2015). The objective of this study is to compare VTE-related healthcare resource utilization and costs of cancer patients treated with anticoagulant therapies. Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant agent received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban. Inverse probability of treatment weights based on propensity score was used to adjust for differences between treatment cohorts. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE-related resource utilization and costs were identified with a primary or secondary diagnosis of deep vein thrombosis or pulmonary embolism and were evaluated for the entire follow up period, starting from the initiation of the anticoagulant therapy until the earliest either end of enrollment or end of data availability (05/31/2015). Resource utilization components included: number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. Comparisons between the different treatment cohorts were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. Healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference. Results: A total of 2,428 patients (LMWH: n=660; warfarin; n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced across the treatment cohorts including hospitalizations, emergency room (ER) visits, and outpatient visits. Compared to patients treated with LMWH, patients treated with rivaroxaban had significantly fewer VTE-related hospitalizations, hospitalization days, ER visits, and outpatient visits (Figure 1). This resulted in significantly higher VTE-related health care cost difference of $12,000 for LMWH relative to rivaroxaban treatment cohort (Table 1). Patients treated with rivaroxaban had significantly lower VTE-related resource utilization compared to patients treated with warfarin (Figure 1). The total VTE-related costs were however similar between two cohorts (Table 1). The higher drug costs ($1,519) were offset by significantly lower outpatient (-$1,039) and hospitalization costs (-$522) in rivaroxaban relative to warfarin cohort. Conclusion: Healthcare resource use and costs associated with VTE treatment in cancer patients are the highest with LMWH relative to warfarin and rivaroxaban treatments. Healthcare resources use and costs are significantly higher in warfarin relative to rivaroxaban cohort but these resource costs were offset by higher drug costs of rivaroxaban. These results are in line with previous study in cancer patients that found fewer re-hospitalizations related to VTE recurrences in patients treated with rivaroxaban compared to patient treated with LMWH or warfarin (Streiff, 2016). Figure 1 VTE-Related Healthcare Resource Utilization Figure 1. VTE-Related Healthcare Resource Utilization Table VTE-Related Health Care Costs, PPPY Table. VTE-Related Health Care Costs, PPPY Disclosures Streiff: Roche: Research Funding; Portola: Research Funding; Janssen: Consultancy, Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Sanofi: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria.

Description: Background: Both the simplified Pulmonary Embolism Severity Index (sPESI) and the multivariable In-hospital Mortality for Pulmonary embolism using Claims daTa (IMPACT) rule classify patients' risk of early post-pulmonary embolism (PE) complications. Objective: To externally validate sPESI and IMPACT for predicting 90-day all-cause mortality and readmission rates among PE patients treated within the Veterans Health Administration (VHA). Methods: We used VHA data from 10/1/2010-9/30/2015 to identify adult patients with: (1) ≥1 inpatient diagnosis for acute PE (International Classification of Diseases-9th Revision-Clinical Modification codes=415.1x), (2) continuous medical and pharmacy enrollment for ≥12-months prior to the index PE (baseline period), (3) a minimum of 90-days of post-event follow-up or until death (whichever came first), and (4) ≥1 claim for an anticoagulant during the index PE stay. Patients were excluded if they had a claim for PE or an anticoagulant during the baseline period. We classified patients as low-risk for early post-PE complications if their sPESI score=0 or their absolute in-hospital mortality risk estimated by IMPACT was 90% and NPVs 〉96% for all-cause 90-day mortality, but low specificity and PPVs (Table). IMPACT's sensitivity for all-cause readmission was numerically higher than sPESI, but both had comparable NPVs. Similar trends were observed for accuracy in predicting readmissions due to recurrent VTE or major bleeding. Conclusion: In this external validation study utilizing VHA data, IMPACT classified patients for 90-day post-PE outcomes with similar accuracy as sPESI. While not recommended for prospective clinical decision-making, IMPACT appears useful for identification of PE patients at low-risk for early mortality or readmission in retrospective claims-based studies. Table. Test characteristics for sPESI and IMPACT for 90-day post-pulmonary embolism outcomes CI= confidence interval; IMPACT=In-hospital Mortality for Pulmonary embolism using Claims data; NPV=negative predictive value; PPV=positive predictive value; sPESI=simplified Pulmonary Embolism Severity Index; VTE=venous thromboembolism Table. Test characteristics for sPESI and IMPACT for 90-day post-pulmonary embolism outcomes CI= confidence interval; IMPACT=In-hospital Mortality for Pulmonary embolism using Claims data; NPV=negative predictive value; PPV=positive predictive value; sPESI=simplified Pulmonary Embolism Severity Index; VTE=venous thromboembolism Disclosures Kumar: Johnson & Johnson: Employment. Wells:Itreas: Other: Served on a Writing Committee; Janssen Pharmaceuticals: Consultancy; Bayer Healthcare: Other: Speaker Fees and Advisory Board; BMS/Pfizer: Research Funding. Peacock:Comprehensive Research Associates LLC: Equity Ownership; Cardiorentis: Consultancy, Research Funding; The Medicine's Company: Consultancy, Research Funding; Banyan: Research Funding; Emergencies in Medicine LLC: Equity Ownership; Abbott: Research Funding; Alere: Consultancy, Research Funding; Prevencio: Consultancy; Janssen: Consultancy, Research Funding; Portola: Consultancy, Research Funding; Pfizer: Research Funding; Roche: Research Funding; ZS Pharma: Consultancy, Research Funding; Ischemia Care: Consultancy; Phillips: Consultancy. Fermann:Janssen Pharmaceuticals: Other: Advisory Board, Speakers Bureau; Pfizer: Research Funding. Wang:Janssen Pharmaceuticals: Research Funding. Baser:Janssen Pharmaceuticals: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Crivera:Johnson & Johnson: Employment, Equity Ownership, Other: Owns excess of $10,000 in stock. Coleman:Boehringer-Ingelheim Pharmaceuticals, inc.: Consultancy, Research Funding; Bayer Pharmaceuticals AG: Consultancy, Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding.

Description: Background: Current guidelines suggest that low risk pulmonary embolism (PE) patients may be managed as outpatients or with an abbreviated hospital stay. There is need for a claims-based prediction rule that payers and hospitals can use to efficiently risk stratify PE patients. The authors recently derived a rule found to have high sensitivity and moderate specificity for predicting in-hospital mortality. Objective: To validate the In-hospital Mortality for PulmonAry embolism using Claims daTa (IMPACT) prediction rule originally developed in a commercial claims database in an all-payer administrative database restricted to inpatient claims. Methods: This study utilized data from the 2012 Healthcare Cost and Utilization Project Nationwide Inpatient Sample (NIS). Adult PE admissions were identified by the presence of an appropriate International Classification of Diseases, ninth edition, Clinical Modification (ICD-9-CM) code either in the primary position or secondary position when accompanied by a primary code for a PE complication. The IMPACT rule, consists of age + 11 weighted comorbidities calculated based upon the maximum of 25 ICD-9-CM diagnosis codes and 25 procedural codes reported for each discharge in the NIS (myocardial infarction, chronic lung disease, stroke, prior major bleeding, atrial fibrillation, cognitive impairment, heart failure, renal failure, liver disease, coagulopathy, cancer), and was used to estimate patients' risk of in-hospital mortality. Low risk was defined as in-hospital mortality ≤1.5%. We present the validity of the rule by calculating prognostic test characteristics and 95% confidence intervals (CIs). In order to estimate the potential cost savings from an early discharge, we calculated the difference in total hospital costs between low-risk patients having and not having an abbreviated hospital stay (defined as ≤1, ≤2 or ≤3 days). Results: A total of 34,108 admissions for PE were included (46.7% male, mean ± standard deviation age of 61.9±17.2); and we observed a 3.4% in-hospital PE case-fatality rate. The IMPACT prediction rule classified 11,025 (32.3%) patient admissions as low-risk; and had a sensitivity of 92.4% (95%CI=90.7-93.8), specificity of 33.2% (95%CI=32.7-33.7), negative and positive predictive values of 99.2% (95%CI=99.0-99.4) and 4.6% (95%CI=4.4-4.9) and a C-statistic of 0.74 (95%CI=0.73-0.76) for in-hospital mortality. Low-risk patients had significantly lower in-hospital mortality (0.8% vs. 4.6%, odds reduction of 83%; 95%CI=79-87), shorter LOSs (-1.2 days, p

Description: Background: Observation stays are intended to assess patients for short periods (i.e., 2-midnights, total hospital costs and risk of readmission for venous thromboembolism (VTE) or major bleeding during the same month or 2 months subsequent to the index event were compared between propensity-score-matched treatment cohorts. Results: A total of 401 rivaroxaban patients were matched to 401 patients receiving parenteral bridging to warfarin.Rivaroxaban use was associated with a shorter LOS (-0.25 days), fewer encounters lasting 〉2 midnights (21.1% vs. 32.7%) and lower total hospital costs (-$240) vs. parenteral bridging to warfarin (p²0.03 for all) (Table). Readmission was similar between cohorts (p〉0.99 for both VTE and major bleeding readmission). Conclusion: Shorter LOS and lower hospital costs occurred with rivaroxaban vs. parenteral bridging to warfarin in PE observation stay patients. This was achieved without increasing short-term risk of VTE or major bleeding readmission. Table Table. Disclosures Peacock: Portola: Consultancy, Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding. Fermann:Janssen Pharmaceuticals: Other: Advisory Board, Speakers Bureau; Pfizer: Research Funding. Baugh:Janssen Pharmaceuticals: Consultancy; Roche Diagnostics: Other: Advisory Board. Wells:Janssen Pharmaceuticals: Consultancy; Bristol Myers Squib: Research Funding; Pfizer: Research Funding; Bayer Healthcare: Other: Advisory Board, Speakers Bureau; Itreas: Other: Writing Committee. Ashton:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Wildgoose:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Coleman:Boehringer-Ingelheim Pharmaceuticals, inc.: Consultancy, Research Funding; Bayer Pharmaceuticals AG: Consultancy, Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding.

Description: Abstract 1068 Poster Board I-90 Introduction: Anticoagulant therapy is recommended for preventing venous thromboembolism (VTE) among patients undergoing total hip arthroplasty (THA). During warfarin therapy, monitoring of international normalized ratio (INR) is necessary to avoid underdosing (which can lead to VTE and associated events) or overdosing (which can lead to significant bleeding). The purpose of this project was to investigate the distribution of out-of-range INR results among warfarin-treated patients undergoing THA. Patients and Methods: A retrospective cohort analysis was conducted using the MedMining® database of electronic medical record. Data were obtained for patients with a THA procedure and a prescription for warfarin issued within 3 days of surgery from January 1, 2004 through January 31, 2009. We identified INR results following surgery during warfarin therapy for up to 90 days. INR results were categorized as in therapeutic range (2–3), below range (〈 2), or above range (〉 3). For each patient, we calculated the proportion of INR results in each category. Time to first in-range INR was calculated as days from warfarin start to first in-range level for those with at least 1 in-range level. Results: Of 1512 eligible patients, 58.4% were aged 65 years and above, 57.5% were female, and 98.5% were White/Caucasian. The most common reason for surgery was osteoarthritis (78.4%) and the mean length of hospital stay was 4.0 days (SD, 2.5 days). Most patients (77.6%) had 2 or more INR levels during warfarin exposure; 39.9% had 5 or more INR values. Among the 1173 patients with at least 2 INR levels available, patients had a mean of 15.7% of INR values within therapeutic range, 82.1% of INR levels below the therapeutic range and 2.2% of values above range. A total of 53.3% of patients with at least 2 INR levels had no INR fall within the therapeutic range. The median time to first in-range INR was 7 days (range 1-80 days). Conclusions: This population-based observational study found poor warfarin anticoagulation control in THA patients with only about half of patients having INRs within the therapeutic range. INR levels above the therapeutic range were rare, but many patients received insufficient doses of warfarin to achieve therapeutic INR levels. Among those who did achieve at least one in-range INR, the time to achieve this was long, exposing the patient to the risk of VTE during the highest post-op risk period (i.e., within the first 7 days after surgery). It is possible that surgeons are targeting sub therapeutic INR ranges or patients have poor adherence to warfarin therapy; the data do not permit an investigation of physicians' targets or whether patients took the medication as prescribed. These research findings may not be generalizable to the broader US population. A study of the consequences of INR values below the therapeutic range in the THA population is warranted. Disclosures: Kachroo: Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding; United BioSource Corp: Employment. Nordstrom:United BioSource Corp: Employment; Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Nutescu:Ortho-McNeil Janssen Scientific Affairs, LLC: Research Funding. Schein:Ortho-McNeil Janssen Scientific Affairs, LLC: Employment. Bookhart:Ortho-McNeil Janssen Scientific Affairs, LLC: Employment, Equity Ownership.