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Dabigatran trial in patients with mechanical valves halted due to excess of bleeding

A major anticoagulant trial has had to be halted early due to an excess of thromboembolic and bleeding complications in the dabigatran group, compared with those taking warfarin.

The study in patients recently fitted with mechanical heart valves, adds to the debate surrounding the safety of the new oral anticoagulants.

But it also comes as a separate analysis - published today - suggests the drugs are the ‘most promising treatments’ to reduce cardiovascular events and all-cause mortality in patients with atrial fibrillation.

The RE-ALIGN study - which has just been publised in the NEJM - looked at 252 patients with aortic or mitral valve replacement within the past seven days or  at least three months earlier. They were randomly assigned to receive dabigatran or warfarin.

Major bleeding occurred in seven patients on dabigatran (4%) and two patients (2%) on warfarin. All patients with major bleeding had pericardial bleeding.

Read the full story with more details- plus an update on the dabigatran data so far.



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