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ACP Journal Club |17 December 2013

Dabigatran increased bleeding and stroke compared with warfarin after mechanical heart valve implantation

Theodore J. Kolias, MD

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Eikelboom JW, Connolly SJ, Brueckmann M, et al; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369:1206-14. 23991661

Cardiology:

Does dabigatran prevent thromboembolic complications compared with warfarin after implantation of mechanical heart valves?
Randomized controlled trial (Randomized Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement [RE-ALIGN]). ClinicalTrials.gov NCT01452347 and NCT01505881.
Concealed.*
Blinded* (event adjudication committee and echocardiogram analysis).
{Mean 26 weeks; maximum 55 weeks}†. The trial was stopped early for harm.
39 centers in 10 countries.
252 patients 18 to 75 years...
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Kolias TJ. Dabigatran increased bleeding and stroke compared with warfarin after mechanical heart valve implantation. Ann Intern Med. 2013;159:JC6. doi: https://doi.org/10.7326/0003-4819-159-12-201312170-02006

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Published: Ann Intern Med. 2013;159(12):JC6.

DOI: 10.7326/0003-4819-159-12-201312170-02006

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