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      Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients : The ARISTOPHANES Study

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          Abstract

          Supplemental Digital Content is available in the text.

          Abstract

          Background and Purpose—

          This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non–vitamin K antagonist oral anticoagulants (NOACs) or warfarin.

          Methods—

          A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts.

          Results—

          A total of 285 292 patients were included in the 6 matched cohorts: 57 929 apixaban-warfarin, 26 838 dabigatran-warfarin, 83 007 rivaroxaban-warfarin, 27 096 apixaban-dabigatran, 62 619 apixaban-rivaroxaban, and 27 538 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.61; 95% CI, 0.54–0.69), dabigatran (HR, 0.80; 95% CI, 0.68–0.94), and rivaroxaban (HR, 0.75; 95% CI, 0.69–0.82) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.58; 95% CI, 0.54–0.62) and dabigatran (HR, 0.73; 95% CI, 0.66–0.81) had lower rates of MB, and rivaroxaban (HR, 1.07; 95% CI, 1.02–1.13) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs.

          Conclusions—

          In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients.

          Clinical Trial Registration—

          URL: https://www.clinicaltrials.gov/. Unique identifier: NCT03087487.

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          Most cited references 38

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          A new method of classifying prognostic comorbidity in longitudinal studies: development and validation.

          The objective of this study was to develop a prospectively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies. A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients. The 1-yr mortality rates for the different scores were: "0", 12% (181); "1-2", 26% (225); "3-4", 52% (71); and "greater than or equal to 5", 85% (82). The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up. The percent of patients who died of comorbid disease for the different scores were: "0", 8% (588); "1", 25% (54); "2", 48% (25); "greater than or equal to 3", 59% (18). With each increased level of the comorbidity index, there were stepwise increases in the cumulative mortality attributable to comorbid disease (log rank chi 2 = 165; p less than 0.0001). In this longer follow-up, age was also a predictor of mortality (p less than 0.001). The new index performed similarly to a previous system devised by Kaplan and Feinstein. The method of classifying comorbidity provides a simple, readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies. Further work in larger populations is still required to refine the approach because the number of patients with any given condition in this study was relatively small.
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            Dabigatran versus warfarin in patients with atrial fibrillation.

            Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) 2009 Massachusetts Medical Society
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              Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

              The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).
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                Author and article information

                Journal
                Stroke
                Stroke
                STR
                Stroke
                Lippincott Williams & Wilkins
                0039-2499
                1524-4628
                December 2018
                08 November 2018
                : 49
                : 12
                : 2933-2944
                Affiliations
                [1 ]From the Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom (G.Y.H.L.)
                [2 ]Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, United Kingdom (G.Y.H.L.)
                [3 ]Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.)
                [4 ]Health Economics and Outcomes Research, STATinMED Research, Ann Arbor, MI (A.K.)
                [5 ]Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb Company, Lawrenceville, NJ (X. Li, M.H.)
                [6 ]Patient Health & Impact, Outcomes & Evidence, Pfizer, Inc, New York, NY (C.M., J.M.)
                [7 ]US Health Economics and Outcomes Research, Bristol-Myers Squibb Company, Lawrenceville, NJ (K.G., A.N.)
                [8 ]Patient Health & Impact, Outcomes & Evidence, Pfizer, Inc, Groton, CT (X. Luo)
                [9 ]Worldwide Medical, Bristol-Myers Squibb Company, Lawrenceville, NJ (K.F.)
                [10 ]Center for Observational Research and Data Sciences, Bristol-Myers Squibb Company, Lawrenceville, NJ (X.P.)
                [11 ]Deparment of Internal Medicine, University of Michigan, Ann Arbor (O.B.)
                [12 ]Department of Hospital Medicine, Ochsner Clinic Foundation, New Orleans, LA; and Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, LA (S.D.).
                Author notes
                Correspondence to Gregory Y.H. Lip, MD, Price-Evans Professor of Cardiovascular Medicine, University of Liverpool, 6 West Derby St, Liverpool L7 8TX, United Kingdom. Email Gregory.Lip@ 123456liverpool.ac.uk
                Article
                00022
                10.1161/STROKEAHA.118.020232
                6257512
                30571400
                © 2018 The Authors, Bristol-Myers Squibb Company, and Pfizer Inc.

                Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.

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