Advertisement

Direct oral anticoagulants vs non-vitamin K antagonist in atrial fibrillation: A prospective, propensity score adjusted cohort study

Published:January 09, 2019DOI:https://doi.org/10.1016/j.ejim.2018.12.010

      Highlights

      • Effectiveness and safety of DOACs vs VKA have been demonstrated by RCT and observational studies.
      • Some concerns exist about the transferability of these data to specific healthcare contexts
      • In this prospective study, VKAs with TTR >70% and DOACs showed similar effectiveness and safety.
      • We did not observe a lower incidence of intracranial hemorrhages in DOAc cohort.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Connolly S.J.
        • Ezekowitz M.D.
        • Yusuf S.
        • RE-LY Steering Committee and Investigators
        • et al.
        Dabigatran versus warfarin in patients with atrial fibrillation.
        N Engl J Med. 2009; 361: 1139-1151
        • Patel M.R.
        • Mahaffey K.W.
        • Garg J.
        • ROCKET AF Investigators
        • et al.
        Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.
        N Engl J Med. 2011; 365: 883-891
        • Granger C.B.
        • Alexander J.H.
        • McMurray J.J.
        • et al.
        ARISTOTLE committees and investigators. Apixaban versus warfarin in patients with atrial fibrillation.
        N Engl J Med. 2011; 365: 981-992
        • Giugliano R.P.
        • Ruff C.T.
        • Braunwald E.
        • et al.
        ENGAGE AF-TIMI 48 investigators. Edoxaban versus warfarin in patients with atrial fibrillation.
        N Engl J Med. 2013; 369: 2093-2110
        • Adam S.S.
        • McDuffie J.R.
        • Ortel T.L.
        • Williams Jr., J.W.
        Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review.
        Ann Intern Med. 2012; 157: 796-807
        • Dentali F.
        • Riva N.
        • Crowther M.
        • et al.
        Efficacy and Safety of the Novel Oral Anticoagulants in Atrial Fibrillation. A Systematic Review and Meta-Analysis of the Literature.
        Circulation. 2012; 126: 2381-2391
        • Sardar P.
        • Chatterjee S.
        • Wu W.
        • et al.
        New oral anticoagulants are not superior to warfarin in secondary prevention of stroke or transient ischemic attacks but lower the risk of intracranial bleeding: insights from a meta-analysis and indirect treatment comparisons.
        PLoS ONE. 2014; 8: e77694
        • Ruff C.T.
        • Giugliano R.P.
        • Braunwald E.
        • et al.
        Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials.
        Lancet. 2014; 383: 955-962
        • Chan N.C.
        • Paikin J.S.
        • Hirsh J.
        • et al.
        New oral anticoagulants for stroke prevention in atrial fibrillation: impact of study design, double counting and unexpected findings on interpretation of study results and conclusions.
        Thromb Haemost. 2014; 111: 798-807
        • Liew A.
        • O'Donnell M.
        • Douketis J.
        Comparing mortality in patients with atrial fibrillation who are receiving a direct-acting oral anticoagulant or warfarin: a meta-analysis of randomized trials.
        J Thromb Haemost. 2014; 12: 1419-1424
        • Graham D.J.
        • Reichman M.E.
        • Wernecke M.
        • et al.
        Stroke, bleeding, and mortality risks in elderly medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular Atrial fibrillation.
        JAMA Intern Med. 2016; 176: 1662-1667
        • Larsen T.B.
        • Skjøth F.
        • Nielsen P.B.
        • et al.
        Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study.
        BMJ. 2016; 353: i3189
        • Carmo J.
        • Costa F.M.
        • Ferreira J.
        • et al.
        Dabigatran in real-world atrial fibrillation. Meta-analysis of observational comparison studies with vitamin K antagonists.
        Thromb Haemost. 2016; 116: 754-763
        • Beyer-Westendorf J.
        • Camm J.
        • Coleman C.I.
        • et al.
        Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.
        Thromb Haemost. 2016; 116: S13-S23
        • Denas G.
        • Gennaro N.
        • Ferroni E.
        Effectiveness and safety of oral anticoagulation with non-vitamin K antagonists compared to well-managed vitamin K antagonists in naïve patients with non-valvular atrial fibrillation: Propensity score matched cohort study.
        Int J Cardiol. 2017; 249: 198-203
        • Proietti M.
        • Romanazzi I.
        • Romiti G.F.
        • et al.
        Real-world use of apixaban for stroke prevention in atrial fibrillation: a systematic review and meta-analysis.
        Stroke. 2018; 49: 98-106
        • Vaughan Sarrazin M.S.
        • Jones M.
        • Mazur A.
        • et al.
        Bleeding rates in Veterans Affairs patients with atrial fibrillation who switch from warfarin to dabigatran.
        Am J Med. 2014; 127: 1179-1185
        • Ho C.W.
        • Ho M.H.
        • Chan P.H.
        • et al.
        Ischaemic stroke and intracranial haemorrhage with aspirin, dabigatran, and warfarin: impact of quality of anticoagulation control.
        Stroke. 2015; 46: 23-30
        • Haas S.
        • Ten Cate H.
        • Accetta G.
        • et al.
        Quality of vitamin K antagonist control and 1-year outcomes in patients with atrial fibrillation: a global perspective from the GARFIELD-AF registry.
        PLoS One. 2016; 11e0164076
        • Camm A.J.
        • Lip G.Y.
        • De Caterina R.
        • et al.
        ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association.
        Europace. 2012; 14: 1385-1413
        • Heidbuchel H.
        • Vercammen P.
        • Alings M.
        • et al.
        European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation.
        Europace. 2013; 15: 625-651
        • Lip G.Y.
        • Nieuwlaat R.
        • Pisters R.
        • et al.
        Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation.
        Chest. 2010; 137: 263-272
        • Pisters R.
        • Lane D.A.
        • Nieuwlaat R.
        • et al.
        A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey.
        Chest. 2010; 138: 1093-1100
        • Quan H.
        • Sundararajan V.
        • Halfon P.
        • et al.
        Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data.
        Med Care. 2005; 43: 1130-1139
        • Fine J.P.
        • Gray R.J.
        A proportional hazards regression model for the sub-distribution of a competing risk.
        J Am Stat Assoc. 1999; 94: 496-509
        • Rosenbaum P.R.
        • DB Rubin
        The central role of the propensity score in observational studies for causal effects.
        Biometrika. 1983; 70: 41-55
        • D'Agostino R.B.
        Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group.
        Stat Med. 1998; 17: 2265-2281
        • Austin P.C.
        An introduction to propensity score methods for reducing the effects of confounding in observational studies.
        Multivar Behav Res. 2011; 46: 399-424
        • Austin P.C.
        Goodness-of-fit diagnostics for the propensity score model when estimating treatment effects using covariate adjustment with the propensity score.
        Pharmacoepidemiol Drug Saf. 2008; 17: 1202-1217
        • Cohen J.
        Statistical Power Analysis for the Behavioral Sciences.
        Academic Press, New York1977
        • Ntaios G.
        • Papavasileiou V.
        • Makaritsis K.
        • et al.
        Real-world setting comparison of nonvitamin-k antagonist oral anticoagulants versus vitamin-k antagonists for stroke prevention in atrial fibrillation: a systematic review and meta-analysis.
        Stroke. 2017; 48: 2494-2503
        • Bouillon K.
        • Bertrand M.
        • Maura G.
        • et al.
        Risk of bleeding and arterial thromboembolism in patients with non-valvular atrial fi brillation either maintained on a vitamin K antagonist or switched to a non-vitamin K-antagonist oral anticoagulant: a retrospective, matched-cohort study.
        Lancet Haematol. 2015; 2: e150-e159
        • Norby F.L.
        • Bengtson L.G.S.
        • Pl Lutsey
        • et al.
        Comparative effectiveness of rivaroxaban versus warfarin or dabigatran for the treatment of patients with non-valvular atrial fibrillation.
        BMC Cardiovasc Disord. 2017; 17: 238
        • Li X.S.
        • Deitelzweig S.
        • Keshishian A.
        • et al.
        Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in "real-world" clinical practice. A propensity-matched analysis of 76,940 patients.
        Thromb Haemost. 2017; 117: 1072-1082
        • Gruppo di lavoro multidisciplinare
        Documento di indirizzo sul ruolo dei nuovi anticoagulanti orali (NAO) nella prevenzione del cardioembolismo nel paziente con fibrillazione atriale non valvolare.
        in: Assessorato alla Sanità e Politiche Sociali Regione Emilia Romagna, aggiornamento maggio. 2017 (Available at) (Accessed April 25, 2018)

      Linked Article

      • The management of anticoagulant treatment in non-valvular atrial fibrillation real-world patients
        European Journal of Internal MedicineVol. 62
        • Preview
          The interest on the primary and secondary prevention of stroke in patients with non-valvular atrial fibrillation (NVAF) has greatly increased after the introduction of the direct oral anticoagulants (DOAC). Following the results of pivotal phase III randomized clinical trials (RCT), current international guidelines, such as those published by the European Society of Cardiology, recommend the use of DOACs over vitamin K antagonists (VKAs) for stroke prevention in patients with NVAF as they offer a favorable balance between efficacy and safety [1].
        • Full-Text
        • PDF