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dc.contributor.authorHankey, GJ
dc.contributor.authorPatel, MR
dc.contributor.authorStevens, SR
dc.contributor.authorBecker, RC
dc.contributor.authorBreithardt, G
dc.contributor.authorCarolei, A
dc.contributor.authorDiener, H-C
dc.contributor.authorDonnan, GA
dc.contributor.authorHalperin, JL
dc.contributor.authorMahaffey, KW
dc.contributor.authorMas, J-L
dc.contributor.authorMassaro, A
dc.contributor.authorNorrving, B
dc.contributor.authorNessel, CC
dc.contributor.authorPaolini, JF
dc.contributor.authorRoine, RO
dc.contributor.authorSinger, DE
dc.contributor.authorWong, L
dc.contributor.authorCaliff, RM
dc.contributor.authorFox, KAA
dc.contributor.authorHacke, W
dc.date.available2014-05-22T08:15:11Z
dc.date.issued2012-04-01
dc.identifierpii: S1474-4422(12)70042-X
dc.identifier.citationHankey, G. J., Patel, M. R., Stevens, S. R., Becker, R. C., Breithardt, G., Carolei, A., Diener, H. -C., Donnan, G. A., Halperin, J. L., Mahaffey, K. W., Mas, J. -L., Massaro, A., Norrving, B., Nessel, C. C., Paolini, J. F., Roine, R. O., Singer, D. E., Wong, L., Califf, R. M. ,... Hacke, W. (2012). Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. LANCET NEUROLOGY, 11 (4), pp.315-322. https://doi.org/10.1016/S1474-4422(12)70042-X.
dc.identifier.issn1474-4422
dc.identifier.urihttp://hdl.handle.net/11343/33177
dc.descriptionC1 - Journal Articles Refereed
dc.description.abstractBACKGROUND: In ROCKET AF, rivaroxaban was non-inferior to adjusted-dose warfarin in preventing stroke or systemic embolism among patients with atrial fibrillation (AF). We aimed to investigate whether the efficacy and safety of rivaroxaban compared with warfarin is consistent among the subgroups of patients with and without previous stroke or transient ischaemic attack (TIA). METHODS: In ROCKET AF, patients with AF who were at increased risk of stroke were randomly assigned (1:1) in a double-blind manner to rivaroxaban 20 mg daily or adjusted dose warfarin (international normalised ratio 2·0-3·0). Patients and investigators were masked to treatment allocation. Between Dec 18, 2006, and June 17, 2009, 14 264 patients from 1178 centres in 45 countries were randomly assigned. The primary endpoint was the composite of stroke or non-CNS systemic embolism. In this substudy we assessed the interaction of the treatment effects of rivaroxaban and warfarin among patients with and without previous stroke or TIA. Efficacy analyses were by intention to treat and safety analyses were done in the on-treatment population. ROCKET AF is registered with ClinicalTrials.gov, number NCT00403767. FINDINGS: 7468 (52%) patients had a previous stroke (n=4907) or TIA (n=2561) and 6796 (48%) had no previous stroke or TIA. The number of events per 100 person-years for the primary endpoint in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (2·79% rivaroxaban vs 2·96% warfarin; hazard ratio [HR] 0·94, 95% CI 0·77-1·16) and those without (1·44%vs 1·88%; 0·77, 0·58-1·01; interaction p=0·23). The number of major and non-major clinically relevant bleeding events per 100 person-years in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (13·31% rivaroxaban vs 13·87% warfarin; HR 0·96, 95% CI 0·87-1·07) and those without (16·69%vs 15·19%; 1·10, 0·99-1·21; interaction p=0·08). INTERPRETATION: There was no evidence that the relative efficacy and safety of rivaroxaban compared with warfarin was different between patients who had a previous stroke or TIA and those who had no previous stroke or TIA. These results support the use of rivaroxaban as an alternative to warfarin for prevention of recurrent as well as initial stroke in patients with AF. FUNDING: Johnson and Johnson Pharmaceutical Research and Development and Bayer HealthCare.
dc.formatapplication/pdf
dc.languageEnglish
dc.publisherELSEVIER SCIENCE INC
dc.subjectClinical Pharmacology and Therapeutics; Cardiology (incl. Cardiovascular Diseases); Expanding Knowledge in the Medical and Health Sciences; Cardiovascular System and Diseases
dc.titleRivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF
dc.typeJournal Article
dc.identifier.doi10.1016/S1474-4422(12)70042-X
melbourne.peerreviewPeer Reviewed
melbourne.affiliationThe University of Melbourne
melbourne.affiliation.departmentFlorey Department Of Neuroscience And Mental Health
melbourne.source.titleLANCET NEUROLOGY
melbourne.source.volume11
melbourne.source.issue4
melbourne.source.pages315-322
melbourne.publicationid196954
melbourne.elementsid402974
melbourne.contributor.authorDonnan, Geoffrey
melbourne.contributor.authorWijeratne, Tissa
melbourne.contributor.authorParsons, Mark
dc.identifier.eissn1474-4465
melbourne.fieldofresearch321402 Clinical pharmacology and therapeutics
melbourne.fieldofresearch320101 Cardiology (incl. cardiovascular diseases)
melbourne.seocode280103 Expanding knowledge in the biomedical and clinical science
melbourne.seocode200199 Clinical health not elsewhere classified
melbourne.accessrightsThis item is currently not available from this repository


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