End of study transition from study drug to open-label vitamin K antagonist therapy: the ROCKET AF experience.

Published

Journal Article

BACKGROUND: To evaluate the previously reported excess of thromboembolic events during the 30 days after the end of study (EOS) visit when participants transitioned from blinded therapy to open-label vitamin K antagonist. METHODS AND RESULTS: At the EOS visit, open-label vitamin K antagonist was recommended, and the international normalized ratio (INR) was not to be measured until 3 days later to preserve blinding. We analyzed transition strategies, clinical outcomes, and INR values. Event rates are per 100 patient-years. A total of 9248 (65%) participants were taking study drug at EOS, and, between days 3 and 30, an excess of stroke and systemic embolic events were observed in participants assigned to rivaroxaban (rivaroxaban 22 events, event rate 6.42; warfarin 6 events, event rate 1.73; hazard ratio, 3.72; 95% confidence interval, 1.51-9.16; P=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.

Full Text

Duke Authors

Cited 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, KAA

Published Date

  • July 2013

Published In

Volume / Issue

  • 6 / 4

Start / End Page

  • 470 - 478

PubMed ID

  • 23759472

Pubmed Central ID

  • 23759472

Electronic International Standard Serial Number (EISSN)

  • 1941-7705

International Standard Serial Number (ISSN)

  • 1941-7713

Digital Object Identifier (DOI)

  • 10.1161/circoutcomes.113.000132

Language

  • eng