Ximelagatran was not inferior to warfarin for preventing stroke and systemic embolism in non-valvular atrial fibrillation

doi:10.1136/ebm.10.4.110

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Evidence-Based Medicine 2005;10:110; doi:10.1136/ebm.10.4.110
Copyright © 2005 by the BMJ Publishing Group Ltd.

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Therapeutics

Ximelagatran was not inferior to warfarin for preventing stroke and systemic embolism in non-valvular atrial fibrillation

Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA 2005;293:690–8.[Abstract/Free Full Text]

Q In patients with non-valvular atrial fibrillation requiring long term oral anticoagulant therapy, is fixed dose oral ximelagatran non-inferior to adjusted dose warfarin for preventing stroke and systemic embolism?

Clinical impact ratings GP/FP/Primary care $*$ $*$ $*$ $*$ $*$ ${star}$ ${star}$ IM/Ambulatory care $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Internal medicine $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Haematology $*$ $*$ $*$ $*$ $*$ $*$ $*$ Cardiology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$

Key Words: atrial fibrillation • azetidines • cerebrovascular accident • warfarin

The first 150 words of the full text of this article appear below.

METHODS
Design: randomised controlled trial (Stroke Prevention using an OralThrombin Inhibitor in Atrial Fibrillation [SPORTIF] V).

Allocation: concealed.^*

Blinding: blinded (clinicians, patients, and outcome assessors).^*

Follow-up period: mean 20 months.

Setting: 409 sites in the US and Canada.

Patients: 3922 patients (mean age 72y, 69% men) who had persistent orparoxysmal non-valvular atrial fibrillation and $>=$ 1 risk factorfor stroke (eg, previous stroke, transient ischaemic attack,or systemic embolism; hypertension; left ventricular dysfunction;and age $>=$ 75 y or $>=$ 65 y with coronary disease or diabetes mellitus).

Intervention: fixed dose oral ximelagatran, 36 mg twice daily (n = 1960),or adjusted dose warfarin (target international normalised ratio2.0–3.0) (n = 1962).

Outcomes: composite endpoint of stroke (ischaemic and haemorrhagic) orsystemic embolism. Secondary outcomes included major bleeding,major and minor bleeding combined, myocardial infarction, andelevated liver enzymes (serum alanine aminotransferase concentration>3 times the upper limit of normal).

Patient follow . . . [Full text of this article]

Marcel Levi, MD

University of Amsterdam
Amsterdam, The Netherlands