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Open Heart. 2017 Sep 23;4(2):e000682. doi: 10.1136/openhrt-2017-000682. eCollection 2017.

Efficacy and safety of non-vitamin K antagonist oral anticoagulants compared with warfarin in patients with atrial fibrillation.

Author information

1
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.
2
Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Abstract

AIMS:

Non-vitamin K antagonist oral anticoagulants (NOACs) were in pivotal randomised controlled trials at least non-inferior to warfarin for stroke prevention in atrial fibrillation, but time in therapeutic range (TTR) for warfarin was lower (mean 55%-65%) than in Swedish general care where TTR is >70%. We compared efficacy and safety of NOACs and warfarin treatment for stroke prevention in Sweden.

METHODS:

Retrospective cohort study of all non-selected oral anticoagulation naïve atrial fibrillation patients with first prescription for NOACs or warfarin between December 2011 and December 2014, excluding patients with mitral stenosis or mechanical valvular prosthesis. Data were obtained from cross-linked national registers, propensity scores were used as continuous covariates, and associations between treatment and outcomes were evaluated by multivariable Cox regressions.

RESULTS:

The study comprised 18 638 patients on NOAC and 49 418 on warfarin treatment, with 90 204 patient-years follow-up. Age (mean) was 73.4 vs 73.7 years, p<0.001, and CHA2DS2-VASc points (mean) 3.38 vs 3.24, p<0.001, in NOAC and warfarin groups, respectively. HRs (95% CI) for NOACs versus warfarin were 1.04 (0.91-1.19) for all-cause stroke or systemic embolism, 1.16 (1.00-1.35) for ischaemic stroke, 0.85 (0.76-0.96) for major bleeding, 1.22 (1.01-1.46) for gastrointestinal bleeding, 0.60 (0.47-0.76) for intracranial haemorrhage and 0.89 (0.81-0.96) for all-cause mortality.

CONCLUSION:

In this large non-selected anticoagulation naïve Swedish atrial fibrillation cohort, the risks for all-cause stroke or systemic embolism were similar with NOACs and warfarin, but NOACs were associated with significantly lower risks of all-cause mortality, major bleeding and intracranial haemorrhage but higher risk of gastrointestinal bleeding. Better safety suggests NOACs as preferred treatment for patients with atrial fibrillation starting oral anticoagulation.

KEYWORDS:

atrial fibrillation; oral anticoagulation; stroke

Conflict of interest statement

Competing interests: Outside of the present work, LF has received funding from or given lectures for Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Pfizer, Sanofi and St Jude Medical. JO reports advisory board and lecture fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer and Sanofi.

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