From the Publishers of Too Close for Comfort? For How Long Must I Stop This Anticoagulant For an Epidural? COPYRIGHT © 2015, ALL RIGHTS RESERVED Terms of Use The Consult Guys® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the Consult Guys® slide sets constitutes copyright infringement. Copyright © 2015 Copyright © 2015 Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med, 2011; 365: 883-91 Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med, 2011; 365: 883-91 Rocket AF The Black Box warning rationale What happened during the 30 days after study completion? What has led to the Black Box Warning? Copyright © 2015 What happened at completion of study? Warfarin patients continued warfarin Rivaroxaban patients discontinued study drug and then began warfarin Not anticoagulated during warfarin titration Strokes during the 30 days post study Warfarin group: 6 Rivaroxaban group: 22 Copyright © 2015 What was the cause of the post study strokes? Prothrombotic state (Doubt it) No difference in MI post study During study there was no difference in stroke in patients who stopped drug > 3 days Study drug: 2307 treatment interruptions > 3 days 9 strokes Warfarin group: 2668 treatment interruptions>3 days 8 strokes Copyright © 2015 What was the cause of the post study strokes? Inadequate anticoagulation? High risk patients – mean CHADS2 3.5 or higher Anticoagulation interruption in the rivaroxaban group Copyright © 2015 CHADS2 Score Congestive Heart Failure Hypertension Age greater than 75 Diabetic Stroke Greater than 3.5 =High Risk of Stroke Copyright © 2015 Mrs. W CHADS2 = 2 Discontinue the rivaroxaban 48 hours prior to epidural Restart the rivaroxaban 48 hours after epidural Copyright © 2015 Produced by and Copyright © 2015 COPYRIGHT © 2015, ALL RIGHTS RESERVED