Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry
Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice.
Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days).
Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%.
Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.
Author Disclosures: B.A. Steinberg: Other Research Support; Modest; Janssen, Boston Scientific. Consultant/Advisory Board; Modest; BMS. Other; Modest; Medtronic. D.N. Simon: None. L. Thomas: None. J. Ansell: Consultant/Advisory Board; Modest; Pfizer, BMS, Janssen, BI, Alere. G.C. Fonarow: Consultant/Advisory Board; Modest; Medtronic, Amgen, Johnson & Johnson, Bayer, Boston Scientific. Research Grant; Significant; NIH. Consultant/Advisory Board; Significant; Novartis. B.J. Gersh: Consultant/Advisory Board; Modest; Armetheon Inc, Cipla Limited, Janssen Scientific Affairs LLC, Medtronic, Inc. Other; Modest; Baxter Healthcare, Boston Scientific, Cardiovascular Research Foundation, Cardiovascular Research Foundation, Janseen Research & Development LLC, Mount Sinai St. Lukes, St. Jude Medical, Inc, Teva Pharmaceutical Industries, Thrombosis Research Institute. P.R. Kowey: Consultant/Advisory Board; Modest; Johnson and Johnson, Daiichi, Merck, Portola, BI, BMS. K.W. Mahaffey: None. E.D. Peterson: Research Grant; Significant; Janssen, AHA, Eli Lilly. Consultant/Advisory Board; Modest; Merck, BI, Genentech, BMS. J.P. Piccini: Research Grant; Significant; Janssen, Boston Scientific. Consultant/Advisory Board; Modest; Forest Laboratories, Janssen, Medtronic.
- © 2015 by American Heart Association, Inc.