Kenneth W. Mahaffey, MD; Daniel Wojdyla, MS; Graeme J. Hankey, MD; Harvey D. White, DSc; Christopher C. Nessel, MD; Jonathan P. Piccini, MD; Manesh R. Patel, MD; Scott D. Berkowitz, MD; Richard C. Becker, MD; Jonathan L. Halperin, MD; Daniel E. Singer, MD; Robert M. Califf, MD; Keith A.A. Fox, MBChB; Günter Breithardt, MD; Werner Hacke, MD, PhD
Acknowledgment: The authors thank Morgan deBlecourt and Elizabeth Cook of the Duke Clinical Research Institute for editorial support and the ROCKET AF Steering Committee and Investigators.
Grant Support: By Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1644.
Reproducible Research Statement: Study protocol: Available from reference 4. Statistical code and data set: Available from Dr. Mahaffey (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Kenneth W. Mahaffey, MD, Duke Clinical Research Institute, Room 0311 Terrace Level, 2400 Pratt Street, Durham, NC 27705; e-mail, email@example.com.
Current Author Addresses: Drs. Mahaffey, Piccini, Patel, and Becker and Mr. Wojdyla: Duke Clinical Research Institute, Room 0311 Terrace Level, 2400 Pratt Street, Durham, NC 27705.
Dr. Hankey: School of Medicine and Pharmacology, The University of Western Australia, 35 Stirling Highway, Crawley, Perth, Western Australia 6009, Australia.
Dr. White: Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92024, 1030 Auckland, New Zealand.
Dr. Nessel: Janssen Research & Development, 920 Route 202, Raritan, NJ 08869.
Dr. Berkowitz: Bayer HealthCare Pharmaceuticals, PO Box 1000, Mailstop M2/2-7, Montville, NJ 07045-1000.
Dr. Halperin: The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, Mount Sinai Medical Center, Box 1030, Fifth Avenue at 100th Street, New York, NY 10029-6574.
Dr. Singer: Clinical Epidemiology Unit, General Medicine Division, S50-9, Massachusetts General Hospital, Boston, MA 02114.
Dr. Califf: Duke Translational Medicine Institute, Box 3850 Medical Center, Durham, NC 27710.
Dr. Fox: Centre for Cardiovascular Science, University of Edinburgh, 49 Little France Crescent, Edinburgh EH16 4SB, United Kingdom.
Dr. Breithardt: Universitätsklinikum Münster (UKM), Von-Esmarch-Strasse 117, 48149 Münster, Germany.
Dr. Hacke: Department of Neurology, University of Heidelberg, Im Neuenheimer Feld 400, D-69120 Heidelberg, Germany.
Author Contributions: Conception and design: K.W. Mahaffey, G.J. Hankey, H.D. White, C.C. Nessel, M.R. Patel, S.D. Berkowitz, R.C. Becker, C.L. Halperin, D.E. Singer, K.A.A. Fox, G. Breithardt.
Analysis and interpretation of the data: K.W. Mahaffey, D. Wojdyla, H.D. White, C.C. Nessel, J.P. Piccini, M.R. Patel, S.D. Berkowitz, R.C. Becker, C.L. Halperin, D.E. Singer, K.A.A. Fox, G. Breithardt.
Drafting of the article: K.W. Mahaffey, R.C. Becker, R.M. Califf.
Critical revision of the article for important intellectual content: K.W. Mahaffey, D. Wojdyla, G.J. Hankey, H.D. White, J.P. Piccini, M.R. Patel, R.C. Becker, C.L. Halperin, D.E. Singer, K.A.A. Fox, G. Breithardt, W. Hacke.
Final approval of the article: K.W. Mahaffey, D. Wojdyla, G.J. Hankey, H.D. White, C.C. Nessel, J.P. Piccini, M.R. Patel, S.D. Berkowitz, R.C. Becker, C.L. Halperin, D.E. Singer, R.M. Califf, K.A.A. Fox, G. Breithardt, W. Hacke.
Provision of study materials or patients: K.W. Mahaffey, C.C. Nessel, S.D. Berkowitz, R.C. Becker.
Statistical expertise: D. Wojdyla.
Obtaining of funding: K.W. Mahaffey, S.D. Berkowitz.
Administrative, technical, or logistic support: K.W. Mahaffey, R.C. Becker, C.L. Halperin.
Collection and assembly of data: K.W. Mahaffey, H.D. White, C.C. Nessel, J.P. Piccini, S.D. Berkowitz, R.C. Becker.
Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, et al. Clinical Outcomes With Rivaroxaban in Patients Transitioned From Vitamin K Antagonist Therapy: A Subgroup Analysis of a Randomized Trial. Ann Intern Med. 2013;158:861-868. doi: 10.7326/0003-4819-158-12-201306180-00003
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Published: Ann Intern Med. 2013;158(12):861-868.
In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.
To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)–naive and VKA-experienced patients.
Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767)
14 264 persons with atrial fibrillation.
Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.
Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).
The trial was not designed to detect differences in these subgroups.
The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.
Johnson & Johnson and Bayer HealthCare.
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