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The European Society of Cardiology

New advances in stroke prevention in atrial fibrillation: ximelagatran and direct thrombin inhibition

S.Bertil Olsson*

Department of Cardiology, University Hospital, Lund, Sweden

* S. Bertil Olsson, Department of Cardiology, University Hospital, Lund, Sweden. Tel: +46-46-17-35-17; fax: +46-46-17-78-57
bertil.olsson{at}kard.lu.se

Abstract

Ximelagatran is the first oral agent in a new class of direct thrombin inhibitors and is under investigation for the prevention and treatment of a range of thromboembolic disorders. Atrial fibrillation (AF) is associated with a markedly increased risk of stroke and, while study results have consistently demonstrated that anticoagulant therapy with warfarin reduces this risk, there are substantial unmet needs in the management of AF-associated thrombotic risk. In particular, warfarin has unpredictable activity leading to the risk of bleeding complications and the need for routine anticoagulant monitoring.

Ximelagatran has a range of potential benefits over warfarin in the prevention of AF-associated stroke, including predictable anticoagulant activity that is not affected by food and a low potential for drug–drug interactions. Consequently, the risk of bleeding complications may be reduced and there is a fixed-dose regimen with no requirement for routine anticoagulant monitoring. The SPORTIF (Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation) series of studies is investigating the extent to which these potential advantages translate into clinical benefits.

SPORTIF III is a Phase III study of the efficacy and safety of ximelagatran compared with warfarin in the prevention of stroke in 3407 patients with AF. The results demonstrate that ximelagatran has effectiveness non-inferior to well-controlled warfarin in the prevention of stroke and is associated with a lower risk of bleeding complications. With its predictable anticoagulant effect and the enhanced convenience offered by a fixed-dose regimen and with no requirement for routine coagulation monitoring, these results indicate that ximelagatran promises clinical benefits over warfarin that could improve the management of stroke risk in patients with AF.

Key Words: Stroke prevention • Oral direct thrombin inhibitors • Oral vitamin K antagonists • Ximelagatran • Non-valvular atrial fibrillation • SPORTIF lll


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