Abstract 336: Real-World Experiences with Novel Anticoagulants for AF: Initial Insights from ORBIT-AF Phase II
Background: Novel therapies for stroke prevention in atrial fibrillation (AF) are emerging. However, data on use and outcomes of these agents in the community are limited, particularly in patients newly diagnosed with AF or recently transitioned to a novel anticoagulant.
Methods: Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, national, AF registry. We are enrolling 15,000 patients with new-onset AF, or those with known AF recently-transitioned to a novel anticoagulant. The primary objective is to evaluate the safety of novel anticoagulants, with specific focus on use, transitions, and management around invasive procedures and bleeding events. An adaptive design is used to ensure diversity of enrollment across geographic, provider, and treatment groups. The primary outcomes are major bleeding and thromboembolic events.
Results: Of 1,011 patients in ORBIT-AF II, the median age was 73, 44% were female, 23% had a history of heart failure, 34% had a prior MI, and 11% had a prior stroke/TIA. The mean CHADS2 score was 2. Overall, 76% had AF new-onset, and a range of anticoagulant strategies was used in these patients (Figure). Among the 24% with known AF transitioned to a novel agent, 66% received rivaroxaban, versus 8.1% dabigatran, and 26% apixaban. Compared with patients having new-onset AF, those with known AF recently-transitioned to a novel anticoagulant were slightly older (median age 74 vs. 72), had higher CHADS2 scores (>2 in 70% vs. 62%), but less severe kidney disease (0 vs. 1.7%).
Conclusions: Patients with new-onset AF are frequently treated with novel anticoagulants and these patients have lower risk scores than those with known AF transitioned to a novel drug. These data will provide insights into clinical management and patient centered outcomes among those treated with novel anticoagulants in real world practice settings.
Author Disclosures: B.A. Steinberg: None. S. Milford-Beland: None. D. Ollis: None. R. Blanco: None. J. Ansell: G. Consultant/Advisory Board; Modest; Boehringer Ingelheim, Alere, Bristol Myers Squibb, Pfizer, Janssen, Daiichi. G.C. Fonarow: G. Consultant/Advisory Board; Modest; Ortho McNeil. B. Gersh: None. A. Go: None. E. Hylek: D. Speakers; Modest; Boehringer- Ingelheim, Bayer. G. Consultant/Advisory Board; Modest; Daiichi Sankyo, Ortho-McNeil-Janssen, Johnson & Johnson, Boehringer-Ingelheim, Bristol-Myers Squibb, Pfizer. P.R. Kowey: G. Consultant/Advisory Board; Modest; Johnson & Johnson, Daiichi Sankyo, Sanofi, Boehringer Ingelheim, Merck, Bristol Myers Squibb, Portola. K.W. Mahaffey: B. Research Grant; Significant; Johnson and Johnson. G. Consultant/Advisory Board; Significant; Johnson and Johnson. L. Thomas: None. P. Chang: A. Employment; Significant; Janssen Scientific Affairs. E.D. Peterson: B. Research Grant; Significant; American Heart Association, American College of Cardiology, Janssen Pharmaceutical Products, Eli Lilly & Company, Society of Thoracic Surgeons. G. Consultant/Advisory Board; Modest; Merck. J.P. Piccini: B. Research Grant; Significant; Johnson & Johnson / Janssen Pharmaceuticals, Boston Scientific Corporation. C. Other Research Support; Significant; Johnson & Johnson / Janssen Pharmaceuticals. G. Consultant/Advisory Board; Modest; Forest Laboratories, Inc., Medtronic, Inc.. G. Consultant/Advisory Board; Significant; Johnson & Johnson / Janssen Pharmaceuticals.
- © 2014 by American Heart Association, Inc.