End of Study Transition From Study Drug to Open-Label Vitamin K Antagonist Therapy: The ROCKET AF Experience.

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End of Study Transition From Study Drug to Open-Label Vitamin K Antagonist Therapy: The ROCKET AF Experience.

Circ Cardiovasc Qual Outcomes. 2013 Jun 11;

Authors: Mahaffey KW, Hellkamp AS, Patel MR, Hannan KL, Schwabe K, Nessel CC, Berkowitz SD, Halperin JL, Hankey GJ, Becker RC, Piccini JP, Breithardt G, Hacke W, Singer DE, Califf RM, Fox KA

Abstract
BACKGROUND: =0.0044). No INR values were reported for ≈5% of participants transitioned to warfarin. By 30 days after EOS, 83% of the warfarin group and 52% of the rivaroxaban group had ≥1 therapeutic INR value. Median time to first therapeutic INR was 3 days in the warfarin group and 13 days in the rivaroxaban group.Conclusions-The excess of events at EOS was likely because of a period of inadequate anticoagulation in rivaroxaban participants switched to vitamin K antagonist therapy. If transition from rivaroxaban to vitamin K antagonist is needed, timely monitoring and careful dosing should be used to ensure consistent and adequate anticoagulation.

PMID: 23759472 [PubMed - as supplied by publisher]

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