Author + information
- Received April 5, 2019
- Revision received June 21, 2019
- Accepted July 11, 2019
- Published online December 16, 2019.
- Benjamin A. Steinberg, MD, MHSa,∗ (, )
- Nicholas G. Ballew, PhDb,
- Melissa A. Greiner, MSb,
- Steven J. Lippmann, PhDb,
- Lesley H. Curtis, PhDb,c,
- Emily C. O’Brien, PhDb,c,
- Manesh R. Patel, MDc,d and
- Jonathan P. Piccini, MD, MHSb,c,d
- aDivision of Cardiovascular Medicine, University of Utah Health Sciences Center, Salt Lake City, Utah
- bDepartment of Population Health Sciences, Duke University, Durham, North Carolina
- cDuke Clinical Research Institute, Durham, North Carolina
- dCardiology Division, Department of Medicine, Duke University Medical Center, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Benjamin A. Steinberg, University of Utah Cardiovascular Center, 50 North Medical Drive, Salt Lake City, Utah 84132.
Objectives This study sought to describe clinical outcomes among patients with atrial fibrillation (AF) and contraindications to oral anticoagulation (OAC).
Background Treatment with OAC prevents stroke and death in patients with AF, but may be contraindicated among patients at high bleeding risk.
Methods This was an observational, longitudinal analysis of a nationally representative 5% Medicare sample of patients with chronic AF and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) score ≥2. They were stratified by both the presence of high bleeding risk contraindications to OAC and by OAC use. We assessed 3-year ischemic and bleeding outcomes using multivariable Cox proportional hazards models adjusted for relevant patient characteristics.
Results Among 26,684 AF patients not treated with OAC, 8,283 (31%) had a high bleeding risk contraindication, primarily a blood dyscrasia (75%) or history of gastrointestinal bleeding (40%). Without OAC, patients with contraindications had worse ischemic and bleeding outcomes at 3 years compared with those without contraindications. We also identified 12,454 patients with OAC contraindications who received OAC. Compared with patients not receiving OAC, use of OAC was associated with reduced mortality (adjusted hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.76 to 0.83), stroke (adjusted HR: 0.90; 95% CI: 0.83 to 0.99), and all-cause hospitalization (adjusted HR: 0.93; 95% CI: 0.90 to 0.96) but increased risk of intracranial hemorrhage (adjusted HR: 1.42; 95% CI: 1.17 to 1.72).
Conclusions High bleeding risk contraindications to OAC are common among older patients with AF, and these patients have higher mortality compared with untreated patients without OAC contraindications. The use of OAC in these patients is associated with lower rates of all-cause stroke, hospitalization, and death but higher risk of intracranial hemorrhage.
This work was supported by a grant from Boston Scientific. Dr. Steinberg was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number K23HL143156. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Steinberg has received research support from Boston Scientific and Janssen; and has served as a consultant for Biosense Webster, Janssen, and Merit Medical. Dr. Curtis has received grants from GlaxoSmithKline, Novartis, Boston Scientific, and St. Jude. Dr. O’Brien has received grants from Novartis, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi, and Janssen. Dr. Patel has received grant support from Novartis; and has served on the advisory board, as a consultant, and as a speaker for Bayer Pharmaceuticals, AstraZeneca, and Janssen. Dr. Piccini has received funding for clinical research from Abbott Medical, ARCA biopharma, Boston Scientific, Gilead, Janssen Pharmaceuticals, and Verily; and has served as a consultant for Allergan, Bayer, Johnson and Johnson, Medtronic, Sanofi, and Phillips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received April 5, 2019.
- Revision received June 21, 2019.
- Accepted July 11, 2019.
- 2019 American College of Cardiology Foundation
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