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      Neuroimaging and clinical outcomes of oral anticoagulant–associated intracerebral hemorrhage

      1 , 2 , 3 , 1 , 4 , 5 , 6 , 7 , 8 , 7 , 8 , 9 , 10 , 11 , 11 , 12 , 13 , 14 , 15 , 16 , 15 , 17 , 18 , 19 , 20 , 21 , 20 , 22 , 23 , 24 , 25 , 2 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 4 , 32 , 33 , 2 , 34 , 10 , 35 , 36 , 37 , 38 , 39 , 39 , 40 , 3 , 38 , 34 , 32 , 30 , 26 , 41 , 18 , 15 , 42 , 23 , 25 , 43 , 17 , 44 , 2 , 45 , 3
      Annals of Neurology
      Wiley

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          Meta-analysis of Observational Studies in EpidemiologyA Proposal for Reporting

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            Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials.

            Four new oral anticoagulants compare favourably with warfarin for stroke prevention in patients with atrial fibrillation; however, the balance between efficacy and safety in subgroups needs better definition. We aimed to assess the relative benefit of new oral anticoagulants in key subgroups, and the effects on important secondary outcomes. We searched Medline from Jan 1, 2009, to Nov 19, 2013, limiting searches to phase 3, randomised trials of patients with atrial fibrillation who were randomised to receive new oral anticoagulants or warfarin, and trials in which both efficacy and safety outcomes were reported. We did a prespecified meta-analysis of all 71,683 participants included in the RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48 trials. The main outcomes were stroke and systemic embolic events, ischaemic stroke, haemorrhagic stroke, all-cause mortality, myocardial infarction, major bleeding, intracranial haemorrhage, and gastrointestinal bleeding. We calculated relative risks (RRs) and 95% CIs for each outcome. We did subgroup analyses to assess whether differences in patient and trial characteristics affected outcomes. We used a random-effects model to compare pooled outcomes and tested for heterogeneity. 42,411 participants received a new oral anticoagulant and 29,272 participants received warfarin. New oral anticoagulants significantly reduced stroke or systemic embolic events by 19% compared with warfarin (RR 0·81, 95% CI 0·73-0·91; p<0·0001), mainly driven by a reduction in haemorrhagic stroke (0·49, 0·38-0·64; p<0·0001). New oral anticoagulants also significantly reduced all-cause mortality (0·90, 0·85-0·95; p=0·0003) and intracranial haemorrhage (0·48, 0·39-0·59; p<0·0001), but increased gastrointestinal bleeding (1·25, 1·01-1·55; p=0·04). We noted no heterogeneity for stroke or systemic embolic events in important subgroups, but there was a greater relative reduction in major bleeding with new oral anticoagulants when the centre-based time in therapeutic range was less than 66% than when it was 66% or more (0·69, 0·59-0·81 vs 0·93, 0·76-1·13; p for interaction 0·022). Low-dose new oral anticoagulant regimens showed similar overall reductions in stroke or systemic embolic events to warfarin (1·03, 0·84-1·27; p=0·74), and a more favourable bleeding profile (0·65, 0·43-1·00; p=0·05), but significantly more ischaemic strokes (1·28, 1·02-1·60; p=0·045). This meta-analysis is the first to include data for all four new oral anticoagulants studied in the pivotal phase 3 clinical trials for stroke prevention or systemic embolic events in patients with atrial fibrillation. New oral anticoagulants had a favourable risk-benefit profile, with significant reductions in stroke, intracranial haemorrhage, and mortality, and with similar major bleeding as for warfarin, but increased gastrointestinal bleeding. The relative efficacy and safety of new oral anticoagulants was consistent across a wide range of patients. Our findings offer clinicians a more comprehensive picture of the new oral anticoagulants as a therapeutic option to reduce the risk of stroke in this patient population. None. Copyright © 2014 Elsevier Ltd. All rights reserved.
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              Preferred Reporting Items for Systematic Review and Meta-Analyses of individual participant data: the PRISMA-IPD Statement.

              Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas. To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis. Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus. Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach. PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.
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                Author and article information

                Journal
                Annals of Neurology
                Ann Neurol.
                Wiley
                0364-5134
                1531-8249
                October 04 2018
                November 2018
                October 25 2018
                November 2018
                : 84
                : 5
                : 694-704
                Affiliations
                [1 ]Second Department of NeurologyAttikon University Hospital, School of Medicine, National and Kapodistrian University of Athens Athens Greece
                [2 ]Department of NeurologyUniversity of Tennessee Health Science Center Memphis TN
                [3 ]Stroke Research Centre, Department of Brain Repair and Rehabilitation, University College London Institute of Neurology and National Hospital for Neurology and Neurosurgery London, United Kingdom New Zealand Brain Research Institute, Christchurch, New Zealand
                [4 ]Department of NeurologyUniversity of Ioannina School of Medicine Ioannina Greece
                [5 ]Department of NeurologyCentro Hospitalar e Universitário de Coimbra Coimbra Portugal
                [6 ]Faculty of MedicineUniversity of Coimbra Coimbra Portugal
                [7 ]Department of NeurologySão João University Hospital Center Porto Portugal
                [8 ]Department of Clinical Neurosciences and Mental Health, Faculty of MedicineUniversity of Porto Porto Portugal
                [9 ]Department of Neurology and General Internal MedicineTokyo Saiseikai Central Hospital Tokyo Japan
                [10 ]Department of NeurosurgeryGeorg August University of Göttingen Göttingen Germany
                [11 ]Department of Research and Development, Tachikawa Medical Center Nagaoka Japan
                [12 ]Department of Cardiology and Department of Hypertension and Stroke MedicineHirosaki University Graduate School of Medicine Hirosaki Japan
                [13 ]Advanced Arrhythmia Therapeutic Branch, Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center Kumamoto Japan
                [14 ]Hirosaki Stroke and Rehabilitation Center Hirosaki Japan
                [15 ]Stroke Center and NeurologyUniversity Hospital and University of Basel Basel Switzerland
                [16 ]Department of Neurology, Beth Israel Deaconess Medical CenterHarvard Medical School Boston MA
                [17 ]Department of NeurologyHenry Ford Hospital Detroit MI
                [18 ]Ottawa Hospital Research Institute and University of Ottawa Ottawa Ontario Canada
                [19 ]Department of NeurologySt Josef Hospital, Ruhr University Bochum Bochum Germany
                [20 ]Department of NeurologyHeidelberg University Hospital Heidelberg Germany
                [21 ]Division of Neurology, Yong Loo Lin School of MedicineNational University of Singapore Singapore
                [22 ]International Clinical Research Center and Neurology DepartmentSt Anne's Hospital and Masaryk University Brno Czech Republic
                [23 ]Division of Cardiovascular Sciences, School of Medical SciencesUniversity of Manchester, Manchester Academic Health Science Centre Manchester United Kingdom
                [24 ]Department of NeurologyDresden Neurovascular Center Dresden Germany
                [25 ]Department of NeurologyHelsinki University Hospital Helsinki Finland
                [26 ]Stroke Center and Department of NeurologyNational Taiwan University Hospital Taiwan
                [27 ]Second Department of NeurologyAHEPA University Hospital, Aristotle University of Thessaloniki Thessaloniki Greece
                [28 ]Department of NeurologyChristchurch Hospital Christchurch New Zealand
                [29 ]Department of NeurologyDemocritus University of Thrace Alexandroupolis Greece
                [30 ]Department of NeurologyLille University, INSERM U1171, Degenerative and Vascular Cognitive Disorders, CHU Lille Lille France
                [31 ]Department of NeurologyUniversity of Thessaly Larissa Greece
                [32 ]Department of NeurologyMaastricht University Medical Center Maastricht the Netherlands
                [33 ]Department of NeurologyDonders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center Nijmegen the Netherlands
                [34 ]Department of NeurosciencesEastern Health Melbourne Victoria Australia
                [35 ]Neurology DepartmentEgas Moniz Hospital, West Lisbon Hospital Center Lisbon Portugal
                [36 ]CEDOC, Nova Medical SchoolNew University of Lisbon Lisbon Portugal
                [37 ]Department of NeurologyBraga Hospital Braga Portugal
                [38 ]Division of Neurology, Department of Internal Medicine, Faculty of MedicineSaga University Saga Japan
                [39 ]Centre for Clinical Brain Sciences, School of Clinical SciencesUniversity of Edinburgh Edinburgh United Kingdom
                [40 ]Neuroradiological Academic Unit, Department of Brain Repair and Rehabilitation, Institute of NeurologyUniversity College London London United Kingdom
                [41 ]Division of Brain Sciences, Department of Stroke MedicineImperial College London United Kingdom
                [42 ]Neurorehabilitation UnitUniversity of Basel and University Center for Medicine of Aging, Felix Platter Hospital Basel Switzerland
                [43 ]Department of Medicine and Neurology at Royal Melbourne HospitalUniversity of Melbourne Parkville Victoria Australia
                [44 ]Department of Neurology, School of MedicineUniversity of Crete Crete Greece
                [45 ]Department of Statistical ScienceUniversity College London London United Kingdom
                Article
                10.1002/ana.25342
                30255970
                f6916870-4d69-4a27-b121-f22878a346eb
                © 2018

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                http://doi.wiley.com/10.1002/tdm_license_1.1

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