scholarly journals Shifting the Paradigm: A Population Health Approach to the Management of Direct Oral Anticoagulants

2021 ◽  
Author(s):  
Arthur L. Allen ◽  
Jessica Lucas ◽  
David Parra ◽  
Patrick Spoutz ◽  
Jeffery L. Kibert ◽  
...  
Keyword(s):  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Inappropriate Prescribing ◽  
Population Based ◽  
Management Tool ◽  
Management Approach ◽  
Veterans Health ◽  
Health Administration ◽  
The Impact

Abstract Over the past decade, direct oral anticoagulants (DOACs) have contributed to a major paradigm shift in thrombosis management, replacing vitamin K antagonists as the most commonly prescribed anticoagulants in many countries. While DOACs provide distinct advantages over warfarin (eg, convenience, simplicity, and safety), they are frequently associated with inappropriate prescribing and adverse events. These events have prompted regulatory agencies to mandate oversight, which individual institutions may find difficult to comply with given limited resources. Veterans Health Administration (VHA) has leveraged technology to develop the DOAC Population Management Tool (PMT) to address these challenges. This tool has empowered VHA to update a 60‐year standard of care from one‐to‐one provider‐to‐patient anticoagulation monitoring to a population‐based management approach. The DOAC PMT allows for the oversight of all patients prescribed DOACs and leads to intervention only when clinically indicated. Using the DOAC PMT, facilities across VHA have maximized DOAC oversight while minimizing resource usage. Herein, we discuss how the DOAC PMT was conceived, developed, and implemented, along with the challenges encountered throughout the process. Additionally, we share the impact of the DOAC PMT across VHA, and the potential of this approach beyond anticoagulation and VHA.

Abstract 15444: Anticoagulation Treatment of Venous Thromboembolism Across the Weight Spectrum: Insights From the Veterans Health Administration

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Alexander C Perino ◽  
Jun Fan ◽  
Mitra Kothari ◽  
ATIF MOHAMMAD ◽  
Patrick Hlavacek ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Treatment Strategies ◽  
Veterans Health ◽  
Health Administration ◽  
Mechanical Valves ◽  
Consensus Statements ◽  
Body Weights ◽  
Va Health Care System

Introduction: In seminal trials of venous thromboembolism (VTE) treatment with direct oral anticoagulants (DOAC), few patients were enrolled at low and high body weights to estimate treatment effects in these subgroups. Consensus statements have recommended against use of DOACs in VTE for patients ≥120 kg. We sought to describe real-world use of DOACs and other anticoagulants for VTE across the weight spectrum. Methods: We performed a retrospective cohort study of patients with first-time VTE that were treated with anticoagulants in the VA health care system from 2008 to 2018. We excluded patients with 1) additional indications for anticoagulation (atrial fibrillation and mechanical valves) and 2) no documented weight in the 90 days prior to 90 days after index VTE. We stratified patients by weight (<60, 60 to 119, ≥120 kg) and determined 1) index anticoagulation prescription in the 30 days after index VTE (DOAC, warfarin, and low molecular weight heparin or fondaparinux [LMWH/F] only) and 2) variables associated with DOAC prescription, as compared to warfarin, in those ≥120 kg. Results: After excluding 3,676 patients with missing weight, there were 111,774 patients with VTE (64±13 years, 6% female). The most common therapy was warfarin (66%), followed by DOAC (21%), and LMWH/F only (13%). Median weight was 92 kg (interquartile range: 28), with 13,753 patients (12%) with weight ≥120 kg. Across weight categories, proportion of patients receiving DOAC was similar. In patients ≥120 kg, after multivariate adjustment, multiple comorbidities were associated with warfarin prescription while chronic kidney disease was associated with DOAC prescription ( Table ). Conclusion: Weight ≥120 kg is common for VTE patients, with DOAC frequently prescribed despite consensus statements recommending DOAC avoidance. For patients ≥120 kg, comorbidities influence VTE treatment selection, and determination of optimal treatment strategies across the spectrum of comorbidities is needed.

scholarly journals Applying population health approaches to improve safe anticoagulant use in the outpatient setting: the DOAC Dashboard multi-cohort implementation evaluation study protocol

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Geoffrey D. Barnes ◽  
Emily Sippola ◽  
Michael Dorsch ◽  
Joshua Errickson ◽  
Michael Lanham ◽  
...  
Keyword(s):  
Technology Acceptance ◽  
Population Health ◽  
Health Systems ◽  
Adverse Drug Events ◽  
Oral Anticoagulants ◽  
Qualitative Interviews ◽  
Direct Oral Anticoagulants ◽  
Veterans Health ◽  
Health Administration ◽  
Implementation Effort

Abstract Background Use of direct oral anticoagulants (DOAC) is rapidly growing for treatment of atrial fibrillation and venous thromboembolism. However, incorrect dosing of these medications is common and puts patients at risk of adverse drug events. One way to improve safe prescribing is the use of population health tools, including interactive dashboards built into the electronic health record (EHR). As such tools become more common, exploring ways to understand which aspects are effective in specific settings and how to effectively adapt and implement in existing anticoagulation clinics across different health systems is vital. Methods This three-phase project will evaluate a current nation-wide implementation effort of the DOAC Dashboard in the Veterans Health Administration (VHA) using both quantitative and qualitative methods. Informed by this evaluation, the DOAC Dashboard will be implemented in four new health systems using an implementation strategy derived from the VHA experience and interviews with providers in those new health systems. Quantitative evaluation of the VHA and non-VHA implementation will follow the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Qualitative interviews with stakeholders will be analyzed using the Consolidated Framework for Implementation Research and Technology Acceptance Models to identify key determinants of implementation success. Discussion This study will (1) evaluate the implementation of an EHR-based population health tool for medication management within a large, nation-wide, highly integrated health system; (2) guide the adoption in a set of four different health systems; and (3) evaluation that multi-center implementation effort. These findings will help to inform future EHR-based implementation efforts in a wide variety of health care settings.

P2529Efficacy and safety of oral anticoagulation in nonagenarian patients with atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Dominguez Rodriguez ◽  
S Raposeiras Roubin ◽  
D Alonso Rodriguez ◽  
S J Camacho Freire ◽  
E Abuassi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Lower Risk ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Events ◽  
The Impact ◽  
Similar Risk

Abstract Introduction Embolic prevention with oral anticoagulation is the cornerstone for the management of patients with atrial fibrillation (AF). However, data about the efficacy and safety of oral anticoagulation in nonagenarian patients are limited. We aimed to analyze the impact of oral anticoagulation in mortality, embolic and hemorrhagic events, in patients ≥90 years with non-valvular AF. Methods We used data from a multicentric registry of 1,750 consecutive nonagenarian patients diagnosed of AF between 2013 and 2018. A propensity-matched analysis was performed to match the baseline characteristics of patients treated or not with oral anticoagulants, and for those treated with vitamin K antagonists (VKAs) vs direct oral anticoagulants (DOACs). The impact of oral anticoagulation in the embolic and hemorrhagic risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For embolic risk, we have considered a stroke, pulmonary or peripheral embolism. For bleeding risk, we have considered any bleeding requiring hospital admission. Results The mean of CHA2DS2-VASC and HASBLED scores was 4.5±1.3 and 2.8±1.0 points, respectively. Most of patients were anticoagulated (70.1%; n=1,256). DOACs were used in 709 patients, and VKAs in 517 patients. During a median follow-up of 25.2 months (IQR 12.2–44.3 months), 988 patients died (56.5%), 180 presented embolic events (10.3%), 186 had bleeding events (10.6%), and 29 had intracranial hemorrhage (ICH, 1.7%). After propensity-score matching, anticoagulation (versus non anticoagulation) was associated with lower mortality rate (HR 0.73, 95% CI 0.60–0.89; p=0.002), less mortality and embolic events (HR 0.77, 95% CI 0.64–0.92; p=0.005), but more bleeding events (HR 2.05, 95% CI 1.25–3.35; p=0.004). In comparison with VKAs, DOACs showed similar risk of mortality and embolic events (HR 1.14, 95% CI 0.88–1.47; p=0.337), and similar risk of bleeding events (HR 0.75, 95% CI 0.43–1.28; p=0.287), although a trend to lower risk of ICH was found (HR 0.17, 95% CI 0.02–1.39; p=0.097). Conclusions Among nonagenarian patients with AF, oral anticoagulation was associated with lower all-cause mortality. Although survival free of embolic events was significantly higher in patients with anticoagulation, the risk of major bleeding was twice than in non-anticoagulated patients. There was not differences between VKAs and DOACs in terms of embolic events and total major bleeding. However, compared with VKAs, DOACs were showed a trend to lower risk of ICH.

scholarly journals Direct Oral Anticoagulant Adherence of Patients With Atrial Fibrillation Transitioned from Warfarin

2021 ◽  
Author(s):  
Krishna N. Pundi ◽  
Alexander C. Perino ◽  
Jun Fan ◽  
Susan Schmitt ◽  
Mitra Kothari ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
International Normalized Ratio ◽  
Veterans Health ◽  
Health Administration ◽  
Ratio Data ◽  
Proportion Of Days Covered ◽  
Increase Risk ◽  
Using Data

Background Reduced time in international normalized ratio therapeutic range (TTR) limits warfarin safety and effectiveness. In patients switched from warfarin to direct oral anticoagulants (DOACs), patient factors associated with low TTR could also increase risk of DOAC nonadherence. We investigated the relationship between warfarin TTR and DOAC adherence in warfarin‐treated patients with atrial fibrillation switched to DOAC. Methods and Results Using data from the Veterans Health Administration, we identified patients with atrial fibrillation switched from warfarin to DOAC (switchers) or treated with warfarin alone (non‐switchers). Logistic regression was used to evaluate association between warfarin TTR and DOAC adherence. We analyzed 128 605 patients (age, 71±9; 1.6% women; CHA 2 DS 2 ‐VASc 3.5±1.6); 32 377 switchers and 96 228 non‐switchers. In 8016 switchers with international normalized ratio data to calculate 180‐day TTR before switch, TTR was low (median 0.45; IQR, 0.26–0.64). Patients with TTR <0.5 were more likely to be switched to DOAC (odds ratio [OR],1.68 [95% CI,1.62–1.74], P <0.0001), as were those with TTR <0.6 or TTR <0.7. Proportion of days covered ≥0.8 was achieved by 76% of switchers at 365 days. In low‐TTR individuals, proportion of days covered ≥0.8 was achieved by 70%, 72%, and 73% of switchers with TTR <0.5, 0.6, and 0.7, respectively. After multivariable adjustment, TTR <0.5 decreased odds of achieving 365‐day proportion of days covered ≥0.8 (OR, 0.49; 0.43–0.57, P <0.0001), with similar relationships for TTR <0.6 and TTR <0.7. In non‐switchers with TTR <0.5, long‐term TTR remained low. Conclusions In patients with atrial fibrillation switched from warfarin to DOAC, most achieved adequate DOAC adherence despite low pre‐switch TTRs. However, TTR trajectories remained low in non‐switchers. Patients with low warfarin TTR more consistently achieved treatment targets after switching to DOACs, although adherence‐oriented interventions may be beneficial.

scholarly journals The Association of Medications and Vaccination with Risk of Pneumonia in Inflammatory Bowel Disease

2019 ◽  
Vol 26 (6) ◽  
pp. 919-925 ◽  
Author(s):  
Martin H Gregory ◽  
Matthew A Ciorba ◽  
Wyndy L Wiitala ◽  
Ryan W Stidham ◽  
Peter Higgins ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Pneumococcal Vaccination ◽  
Population Based ◽  
Tnf Inhibitors ◽  
Veterans Health ◽  
Health Administration ◽  
Increased Risk ◽  
Inflammatory Bowel ◽  
The Impact

Abstract Background Patients with inflammatory bowel disease (IBD) are at increased risk for pneumonia, and corticosteroids are reported to amplify this risk. Less is known about the impact of corticosteroid-sparing IBD therapies on pneumonia risk or the efficacy of pneumococcal vaccination in reducing all-cause pneumonia in real-world IBD cohorts. Methods We performed a population-based study using an established Veterans Health Administration cohort of 29,957 IBD patients. We identified all patients who developed bacterial pneumonia. Cox survival analysis was used to determine the association of corticosteroids at study entry and as a time-varying covariate, corticosteroid-sparing agents (immunomodulators and antitumor necrosis-alpha [TNF] inhibitors), and pneumococcal vaccination with the development of all-cause pneumonia. Results Patients with IBD who received corticosteroids had a greater risk of pneumonia when controlling for age, gender, and comorbidities (hazard ratio [HR] 2.21; 95% confidence interval [CI], 1.90–2.57 for prior use; HR = 3.42; 95% CI, 2.92–4.01 for use during follow-up). Anti-TNF inhibitors (HR 1.52; 95% CI, 1.02–2.26), but not immunomodulators (HR 0.91; 95% CI, 0.77–1.07), were associated with a small increase in pneumonia. A history of pneumonia was strongly associated with subsequent pneumonia (HR = 4.41; 95% CI, 3.70–5.27). Less than 15% of patients were vaccinated against pneumococcus, and this was not associated with a reduced risk of pneumonia (HR = 1.02; 95% CI, 0.80–1.30) in this cohort. Conclusion In a large US cohort, corticosteroids were confirmed to increase pneumonia risk. Tumor necrosis-alpha inhibitors were associated with a smaller increase in the risk of pneumonia. Surprisingly, pneumococcal vaccination did not reduce all-cause pneumonia in this population, though few patients were vaccinated.

scholarly journals Adherence and persistence to direct oral anticoagulants in atrial fibrillation: a population-based study

Heart ◽  
2019 ◽  
Vol 106 (2) ◽  
pp. 119-126 ◽  
Author(s):  
Amitava Banerjee ◽  
Valerio Benedetto ◽  
Philip Gichuru ◽  
Jane Burnell ◽  
Sotiris Antoniou ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Median Number ◽  
Population Based ◽  
Cardiovascular Comorbidities ◽  
One Year ◽  
Over Time

BackgroundDespite simpler regimens than vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), adherence (taking drugs as prescribed) and persistence (continuation of drugs) to direct oral anticoagulants are suboptimal, yet understudied in electronic health records (EHRs).ObjectiveWe investigated (1) time trends at individual and system levels, and (2) the risk factors for and associations between adherence and persistence.MethodsIn UK primary care EHR (The Health Information Network 2011–2016), we investigated adherence and persistence at 1 year for oral anticoagulants (OACs) in adults with incident AF. Baseline characteristics were analysed by OAC and adherence/persistence status. Risk factors for non-adherence and non-persistence were assessed using Cox and logistic regression. Patterns of adherence and persistence were analysed.ResultsAmong 36 652 individuals with incident AF, cardiovascular comorbidities (median CHA2DS2VASc[Congestive heart failure, Hypertension, Age≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category] 3) and polypharmacy (median number of drugs 6) were common. Adherence was 55.2% (95% CI 54.6 to 55.7), 51.2% (95% CI 50.6 to 51.8), 66.5% (95% CI 63.7 to 69.2), 63.1% (95% CI 61.8 to 64.4) and 64.7% (95% CI 63.2 to 66.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. One-year persistence was 65.9% (95% CI 65.4 to 66.5), 63.4% (95% CI 62.8 to 64.0), 61.4% (95% CI 58.3 to 64.2), 72.3% (95% CI 70.9 to 73.7) and 78.7% (95% CI 77.1 to 80.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. Risk of non-adherence and non-persistence increased over time at individual and system levels. Increasing comorbidity was associated with reduced risk of non-adherence and non-persistence across all OACs. Overall rates of ‘primary non-adherence’ (stopping after first prescription), ‘non-adherent non-persistence’ and ‘persistent adherence’ were 3.5%, 26.5% and 40.2%, differing across OACs.ConclusionsAdherence and persistence to OACs are low at 1 year with heterogeneity across drugs and over time at individual and system levels. Better understanding of contributory factors will inform interventions to improve adherence and persistence across OACs in individuals and populations.

Abstract MP23: Neighborhood Disadvantage And Oral Anticoagulant Use In Patients With Atrial Fibrillation

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Anne M McDermott ◽  
Nadejda Kim ◽  
Maria Mor ◽  
MICHAEL J FINE ◽  
Utibe Essien
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Random Effect ◽  
Adverse Outcomes ◽  
System Level ◽  
Veterans Health ◽  
Health Administration ◽  
Increased Risk ◽  
Significant Difference ◽  
The Impact

Background: Atrial Fibrillation (AF) is the most common heart rhythm disorder in the US and is treated with anticoagulation to mediate patients’ increased risk of ischemic stroke and death. Direct-acting oral anticoagulants (DOACs) are associated with better patient outcomes than warfarin, but prior studies show disparities in DOAC prescription. AF patients with low socioeconomic status (SES) have an increased risk of AF incidence, adverse outcomes, and mortality. Despite SES disparities in AF outcomes and prescribed medications, the impact of neighborhood SES (ADI) on AF management is unclear. We hypothesized that in comparison to patients with high ADI (e.g. the most disadvantaged), those with low ADI will be more likely to initiate any oral anticoagulants (OACs) and will be more likely to initiate DOACs. Methods: We conducted a retrospective observational study using national data from the Veterans Health Administration (VA) of newly diagnosed AF patients. Our independent variable was ADI, a marker of SES incorporating income, education, employment etc. Our model assessed numerous baseline patient, provider, and system-level covariates. We grouped patients into ADI quintiles, with Q1 being the lowest ADI (e.g., the least disadvantaged) and Q5 being the highest ADI, and used Q5 as a reference value. We used mixed effects logistic regression models, with site as a random effect, to determine the adjusted odds of initiating any OACs and of initiating DOACs by ADI quintile. Results: In our final cohort including 111,666 patients, 10,9386 (98.0%) were male and 2280 (2.0%) were female. The overall mean age at diagnosis was 72.86 (SD 10.4). Patients had the following medical comorbidities: Congestive heart failure: 18212, (16.3%); Hypertension: 84944, (76.1%); Diabetes: 70673, (63.3%); Vascular Disease: 46599, (41.7%). The ADI quintiles included the following patients: Q1: 21570, (20.3%); Q2: 21032, (19.8%); Q3: 21439, (20.2%); Q4: 20974, (19.8%); Q5: 21215, (20.0%). There was no significant difference in the odds of initiating any OAC between ADI quintiles compared to Q5 (Q1: adjusted odds ratio [95% CI], 0.95 [ 0.9, 1.01]; p=0.11). Among patients initiating DOAC, there was a significant association between low ADI and higher odds of initiating DOAC (Q1: 1.39 [1.29, 1.50]); (Q2: 1.18 [1.10, 1.27]); (Q3: 1.13 [1.06, 1.20]); (Q4: 1.09 [1.02, 1.16]). Each ADI quintile had a significantly higher odds of initiating DOACs compared to the highest ADI quintile. Conclusions: Patients with lower ADI are significantly more likely to be prescribed DOACs compared to patients with the highest levels of ADI. We found no significant difference in initiation of any OAC between ADI quintiles, which may result from high Warfarin utilization in the VA compared to the general population. Our data suggests that differences in neighborhood deprivation contribute to disparities in the prescribing DOACs in the VA.

Abstract 231: Racial and Ethnic Disparities in Anticoagulant Choice for Atrial Fibrillation in the Veterans Health Administration: Results From the REACH AF Study

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Utibe R Essien ◽  
Nadejda Kim ◽  
Leslie Hausmann ◽  
Maria Mor ◽  
Chester Good ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Ethnic Disparities ◽  
Veterans Health ◽  
Health Administration ◽  
Race Ethnicity ◽  
Racial Ethnic

Background: Atrial fibrillation (AF) affects nearly 1 million patients in VA, with morbidity and mortality disproportionately affecting racial/ethnic minorities. Anticoagulation reduces stroke risk in AF, yet warfarin and direct oral anticoagulants (DOACs) are underused in minorities. We compared anticoagulant initiation by race/ethnicity for patients with AF in VA—which facilitates access to medications through a uniform drug formulary. Methods: Using the VA Corporate Data Warehouse, we identified patients from 1/1/2014 - 12/31/2018 with an AF diagnosis and a confirmatory diagnosis ≦180 days of their index AF diagnosis. We excluded patients with an AF diagnosis or anticoagulant therapy in the 2 years prior to their index AF diagnosis, as well as those with valvular heart disease, who died within 180 days of AF diagnosis, or had missing or “other” race/ethnicity. We categorized our independent variable as non-Hispanic white (NHW), non-Hispanic black (NHB), and Hispanic. Our primary outcome was receipt of any anticoagulant ≦180 days of AF diagnosis as well as the type of anticoagulant (warfarin, DOAC) initiated. We used logistic regression to compare outcomes by race/ethnicity, adjusting for year of diagnosis, stroke risk with CHADS2VA2Sc score, renal disease, region and rurality. Results: We identified 148,062 patients with incident AF: 8.6% were NHB, 3.4% Hispanic. Overall, NHBs (57.7%) and Hispanics (58.4%) were less likely than NHWs (61.4%) to initiate any anticoagulant therapy (p <0.01), driven by lower DOAC initiation for minorities (36.8% NHBs, 36.5% Hispanics, 43.0% NHWs; p <0.01). Compared to NHWs, the adjusted odds ratios (AORs) for receiving any anticoagulant or DOACs were significantly lower for NHBs and Hispanics (Table); in contrast, AORs for receiving warfarin were significantly higher among minorities. As DOAC initiation increased from 16.8% (2014) to 60.3% (2018), racial disparities in initiation increased from 1.7 to 9.1% for NHBs vs. NHWs and from 0.9 to 9.4% for Hispanics vs. NHWs. Conclusions: In a national cohort of AF in VA, we identified significant racial/ethnic disparities in anticoagulant initiation, driven by growing disparities in DOAC initiation. Understanding these differences is essential to ensuring equitable AF care in the largest U.S. integrated health care system.

scholarly journals Bleeding in Patients with Atrial Fibrillation Treated with Different Doses of Direct Oral Anticoagulants and Vitamin K Antagonists: A Population-Based Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2617-2617 ◽  
Author(s):  
Martin H. Ellis ◽  
Orly Avnery ◽  
Estela Derazne ◽  
Erez Battat ◽  
Sari Greenberg Dotan ◽  
...  
Keyword(s):  
Research Funding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Case Fatality ◽  
Population Based ◽  
Population Based Study ◽  
Bleeding Rate ◽  
Hazard Ratios ◽  
Different Doses

Abstract INTRODUCTION Recent large randomized controlled trials have shown that direct oral anticoagulants (DOACs) are at least as effective as vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation (AF) and are associated with similar or lower rates of bleeding. The results for bleeding seen in Phase 3 trials might not be applicable to real world practice. Population-based studies suggest that the bleeding risk for DOACs and VKA is similar however neither the risk of bleeding associated with different doses of DOACs nor that associated with apixaban in routine clinical practice is well established. We performed a large population-based study to determine the incidence of bleeding in patients with AF beginning treatment with different doses of dabigatran, rivaroxaban, apixaban or a VKA. METHODS From the computerized database of the 4.5 million member Israeli Clalit Health Services health care provider, consecutive patients initiating a VKA or DOAC for AF between January 1, 2011 and December 31, 2014 were studied. Bleeding patients who required hospitalization were identified and key clinical and laboratory data were recorded. Incidence of bleeding was calculated during the first 20 months of treatment which was the minimum duration of treatment for all of the drugs. Adjusted hazard ratios for overall bleeding, intracranial hemorrhage (ICH) and gastrointestinal (GI) bleeding and all-cause mortality within 30 days were recorded and case fatality rates were calculated as the proportions of bleeding patients who died within 30 days. RESULTS 26184 patients initiated anticoagulants for AF: 14258 received VKA, 214 -received dabigatran 75 mg, 3563 received dabigatran 110 mg , 1410 received dabigatran 150 mg, 2570 received rivaroxaban 15 mg, 2140 received rivaroxaban 20 mg, 1227 received apixaban 2.5 mg and 802 received apixaban 5 mg. Key patient demographics and the overall and site-specific bleeding rates are shown in table 1. Hazard ratios for any bleeding, ICH and GI bleeding adjusted for age, renal failure, CHADS2 score, aspirin use and Charlson comorbidity score favored dabigatran 150 mg versus VKA (P<0.05). The case fatality rate for VKA bleeding was 11,4%, dabigatran 110mg-10.5%, dabigatran 150 mg- 6.25%. rivaroxaban 15mg- 15.5%, rivaroxaban 20 mg- 10%, apixaban 2.5 mg- 11.4% and for apixaban 5mg-7.14% CONCLUSIONS The results of our population-based non-randomized study of unselected AF patients demonstrate a decreased bleeding rate for dabigatran 150mg and an increased bleeding rate for apixaban 2.5 mg compared to VKA. There was a consistent tendency for increased bleeding in patients receiving lower versus higher doses of the NOACs which probably reflects physician tendency to select lower doses of DOACs for patients at greater risk for bleeding. Disclosures Ellis: Boehringer Ingelheim: Speakers Bureau; Bayer: Speakers Bureau; Pfizer: Speakers Bureau. Eikelboom:Pfizer: Honoraria, Research Funding; Eli Lilly: Honoraria, Research Funding; Boehringer Ingelheim: Honoraria, Research Funding; Daiichi-Sankyo: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; Astra Zeneca: Honoraria, Research Funding; Bristol Myer Squibb: Honoraria, Research Funding; Sanofi-Aventis: Honoraria, Research Funding; Janssen: Honoraria, Research Funding.

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