03221nas a2200493   4500000000100000008004100001653001000042653001100052653001100063653000900074653000900083653001600092653002000108653001800128653001500146653004900161653001900210653001300229653002400242653001100266653002500277653003400302653001600336653002700352100001200379700002200391700001300413700002100426700001400447700002300461700001800484700001700502700001700519700002000536700001500556700001500571700002200586700008200608245014500690300001000835490000800845520186000853022001402713       2017                            d10aAdult10aFemale10aHumans10aAged10aMale10aMiddle Aged10aRisk Assessment10aUnited States10aHemorrhage10aOutcome and Process Assessment (Health Care)10aAnticoagulants10aWarfarin10aPatient Readmission10aCanada10aFactor Xa Inhibitors10aMedication Therapy Management10aRivaroxaban10aVenous Thromboembolism1 aJohn O.1 aHemmelgarn Brenda1 aLix Lisa1 aDurand Madeleine1 aDahl Matt1 aJ Paterson Michael1 aDormuth Colin1 aErnst Pierre1 aYao Shenzhen1 aRenoux Christel1 aTamim Hala1 aWu Cynthia1 aMahmud Salaheddin1 aCanadian Network for Observational Drug Effect Studies (CNODES) Investigators00aComparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study.  aj43230 v3593 a<p>
&nbsp;To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism.&nbsp;Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016.&nbsp;Community based, using healthcare data from six jurisdictions in Canada and the United States.&nbsp;59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis.&nbsp;Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites.&nbsp;Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients.&nbsp;In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment.&nbsp;Clinical trials NCT02833987.
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