1. Too Close for Comfort? For How Long Must I Stop This Anticoagulant For an Epidural? COPYRIGHT © 2015, ALL RIGHTS RESERVED From the Publishers of

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3. Copyright © 2015 Sages: I am a long time fan of the two of you and I have a patient care problem that I think that not even the two of you can figure out for sure. Mrs. W is 75 years old and is due to undergo epidural injection of steroid as treatment of severe back and leg pain. Mrs W. has had atrial fibrillation for years. Because of her increased risk of embolic phenomena I initially began treatment with warfarin but last year to increase her convenience I discontinued the warfarin and substituted with rivaroxaban. She’s tolerated this change well. But here is the challenge. The physician who is going to perform the epidural procedure wants the rivaroxaban discontinued for as long as possible prior to the procedure and wants to delay resuming the drug for as long as possible in the post procedure period. He wants me to tell Mrs. W when to stop and then restart the rivaroxaban. I know that any epidural bleeding can cause major morbidity so I want her off anticoagulant therapy for as long as possible but I’ve heard that there is an increased risk of stroke in stopping rivaroxaban. How do I handle this one? Sincerely, Concerned Doc Sages: I am a long time fan of the two of you and I have a patient care problem that I think that not even the two of you can figure out for sure. Mrs. W is 75 years old and is due to undergo epidural injection of steroid as treatment of severe back and leg pain. Mrs W. has had atrial fibrillation for years. Because of her increased risk of embolic phenomena I initially began treatment with warfarin but last year to increase her convenience I discontinued the warfarin and substituted with rivaroxaban. She’s tolerated this change well. But here is the challenge. The physician who is going to perform the epidural procedure wants the rivaroxaban discontinued for as long as possible prior to the procedure and wants to delay resuming the drug for as long as possible in the post procedure period. He wants me to tell Mrs. W when to stop and then restart the rivaroxaban. I know that any epidural bleeding can cause major morbidity so I want her off anticoagulant therapy for as long as possible but I’ve heard that there is an increased risk of stroke in stopping rivaroxaban. How do I handle this one? Sincerely, Concerned Doc

4. Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med, 2011; 365: 883-91

6. What happened during the 30 days after study completion? What has led to the Black Box Warning? Rocket AF The Black Box warning rationale Copyright © 2015

7. 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

8. 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

9. What was the cause of the post study strokes? Inadequate anticoagulation?  High risk patients – mean CHADS 2 3.5 or higher  Anticoagulation interruption in the rivaroxaban group Copyright © 2015

10. CHADS 2 Score Congestive Heart Failure Hypertension Age greater than 75 Diabetic Stroke Greater than 3.5 =High Risk of Stroke Copyright © 2015

11. Mrs. W CHADS 2 = 2 Discontinue the rivaroxaban 48 hours prior to epidural Restart the rivaroxaban 48 hours after epidural Copyright © 2015

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