TY - JOUR
T1 - Discontinuation rates of warfarin versus direct acting oral anticoagulants in US clinical practice
T2 - Results from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II): Discontinuation Rates of Warfarin vs DOACs
AU - Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II
AU - Jackson, Larry R.
AU - Kim, Sunghee
AU - Blanco, Rosalia
AU - Thomas, Laine
AU - Ansell, Jack
AU - Fonarow, Gregg C.
AU - Gersh, Bernard J.
AU - Go, Alan S.
AU - Kowey, Peter R.
AU - Mahaffey, Kenneth W.
AU - Hylek, Elaine M.
AU - Peterson, Eric D.
AU - Piccini, Jonathan P.
N1 - Funding Information:
This project was supported (in part) by funding from the Agency of Healthcare Research and Quality through cooperative agreement number 1 U19 HS021092. The ORBIT-AF registry is sponsored by Janssen Scientific Affairs, LLC, Raritan, NJ. The design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication were all determined by the authors of the manuscript, which included members of the ORBIT-AF II executive committee. One of the funding sources (Janssen) had a non-voting member on this committee.
Funding Information:
This project was supported (in part) by funding from the Agency of Healthcare Research and Quality through cooperative agreement number 1 U19 HS021092 . The ORBIT-AF registry is sponsored by Janssen Scientific Affairs , LLC, Raritan, NJ. The design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication were all determined by the authors of the manuscript, which included members of the ORBIT-AF II executive committee. One of the funding sources (Janssen) had a non-voting member on this committee.
Funding Information:
Dr Larry R. Jackson II reports honoraria from Biotronik Inc and educational support from Medtronic, Boston Scientific, and Biotronik Inc. Sunghee Kim, Laine Thomas, and Rosalia Blanco reports no disclosures. Dr Jack Ansell consulting fees from Janssen pharmaceuticals. Dr Gregg C. Fonarow reports research support from AHRQ and consultancy fees from Janssen and Medtronic. Dr Gersh reports being on data safety and monitoring board for Baxter Healthcare Corporation, Cardiovascular Research Foundation, St. Jude Medical, Boston Scientific, member of steering committee for Medtronic and member of executive committee for Ortho-McNeil Janssen Scientific Affairs. Dr Alan S. Go receives consulting fees from Janssen Pharmaceuticals. Dr Kowey reports serving as a consultant to or on the advisory board of Johnson & Johnson, Daiichi Sankyo, Sanofi, Boehringer Ingelheim, Merck, Bristol Myers Squibb, and Portola. Dr Kenneth W. Mahaffey receives research grants from Medtronic and St. Jude; he has also received consulting fees the American College of Cardiology, AstraZenaca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Elsevier, Forest, Glaxo-Smith-Kline, Johnson & Johnson, Medtronic, Merck, Portola Pharma, Spring Publishing, and The Medicines Company, WebMD. Dr Hylek reports honoraria for consultancy from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Medtronic & Pfizer. Dr Peterson reports receiving research grants from the American Heart Association, the American College of Cardiology, Janssen Pharmaceutical Products, Eli Lilly & Co, and the Society of Thoracic Surgeons, as well as serving as a consultant to or on the advisory board of Merck & Co, Boehringer Ingelheim, Genentech, Sanofi-Aventis, and Janssen Pharmaceutical Products. Dr Piccini reports receiving research grants from Johnson & Johnson/Janssen Pharmaceuticals and Boston Scientific Corp, as well as other research support from Johnson & Johnson/Janssen Pharmaceuticals and consultant/advisory board fees from Forest Laboratories, Inc, Medtronic Inc, and Johnson & Johnson/Janssen Pharmaceuticals.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/8
Y1 - 2020/8
N2 - While oral anticoagulation is a cornerstone of stroke prevention therapy in atrial fibrillation (AF), few studies have evaluated comparative discontinuation rates in clinical practice. The objective of this study is to evaluate discontinuation rates among patients on warfarin and direct oral anticoagulants (DOACs) in clinical practice. Methods: The ORBIT-AF II Registry enrolled 10,005 total AF patients with a CHA2DS2VASc score of ≥2 on warfarin or DOACs from 235 clinical practices across the US from February 13, 2013 and July 12, 2017. Descriptive statistics and multivariable Cox regression modeling were used to describe baseline characteristics and predictors of discontinuation. Unadjusted and adjusted discontinuation rates and 95% confidence intervals (CI) were calculated using Cox proportional hazards models and propensity score adjustment, respectively. Results: At baseline, 16.4% (N = 1642/10,005) were treated with warfarin, 83.6% (N = 8363/10,005) with DOACs and 1498/10,005 patients (15.0%) discontinued therapy [warfarin = 236/1642 (14.4%) vs DOACs = 1262/8363 (15.1%)]. At 6 and 12 months respectively, among 7049 patients with a new diagnosis of AF within 6 months, adjusted discontinuation rates for warfarin versus DOACs were as follows: [6 months: 7.9%, 95%CI (6.8%-9.0%) vs 9.6% (8.4%-10.7%), P = .16]; [12 months: 12.7% (11.0%-14.3%) vs 15.3% (13.6%-16.9%), P = .02)]. Patients who discontinued therapy with warfarin or DOACs had higher risk of adverse clinical outcomes including: all-cause mortality and cardiovascular death (CV) than those who continued treatment. Conclusion: In a community based AF cohort, adjusted rates of discontinuation at 12-months were higher in DOAC-treated versus VKA-treated patients. Discontinuation of oral anticoagulation was associated with increased absolute risk of all-cause mortality and CV death. Clinical Trial Registration: URL:https://clinicaltrials.gov. Unique Identifier: NCT01701817
AB - While oral anticoagulation is a cornerstone of stroke prevention therapy in atrial fibrillation (AF), few studies have evaluated comparative discontinuation rates in clinical practice. The objective of this study is to evaluate discontinuation rates among patients on warfarin and direct oral anticoagulants (DOACs) in clinical practice. Methods: The ORBIT-AF II Registry enrolled 10,005 total AF patients with a CHA2DS2VASc score of ≥2 on warfarin or DOACs from 235 clinical practices across the US from February 13, 2013 and July 12, 2017. Descriptive statistics and multivariable Cox regression modeling were used to describe baseline characteristics and predictors of discontinuation. Unadjusted and adjusted discontinuation rates and 95% confidence intervals (CI) were calculated using Cox proportional hazards models and propensity score adjustment, respectively. Results: At baseline, 16.4% (N = 1642/10,005) were treated with warfarin, 83.6% (N = 8363/10,005) with DOACs and 1498/10,005 patients (15.0%) discontinued therapy [warfarin = 236/1642 (14.4%) vs DOACs = 1262/8363 (15.1%)]. At 6 and 12 months respectively, among 7049 patients with a new diagnosis of AF within 6 months, adjusted discontinuation rates for warfarin versus DOACs were as follows: [6 months: 7.9%, 95%CI (6.8%-9.0%) vs 9.6% (8.4%-10.7%), P = .16]; [12 months: 12.7% (11.0%-14.3%) vs 15.3% (13.6%-16.9%), P = .02)]. Patients who discontinued therapy with warfarin or DOACs had higher risk of adverse clinical outcomes including: all-cause mortality and cardiovascular death (CV) than those who continued treatment. Conclusion: In a community based AF cohort, adjusted rates of discontinuation at 12-months were higher in DOAC-treated versus VKA-treated patients. Discontinuation of oral anticoagulation was associated with increased absolute risk of all-cause mortality and CV death. Clinical Trial Registration: URL:https://clinicaltrials.gov. Unique Identifier: NCT01701817
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U2 - 10.1016/j.ahj.2020.04.016
DO - 10.1016/j.ahj.2020.04.016
M3 - Article
C2 - 32526533
AN - SCOPUS:85086126801
VL - 226
SP - 85
EP - 93
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -