Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF
| Contribuinte(s) |
UNIVERSIDADE DE SÃO PAULO |
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| Data(s) |
07/11/2013
07/11/2013
2012
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| Resumo |
Background 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. Johnson and Johnson Pharmaceutical Research and Development Johnson and Johnson Pharmaceutical Research and Development Bayer HealthCare Bayer HealthCare Ortho McNeil Janssen Ortho McNeil Janssen Bayer Bayer Johnson and Johnson Johnson and Johnson AstraZeneca AstraZeneca GlaxoSmithKline GlaxoSmithKline Boehringer Ingelheim Boehringer Ingelheim Lundbeck Lundbeck Novartis Novartis JanssenCilag SanofiAventis Janssen-Cilag Sanofi-Aventis Syngis Syngis Talecris Talecris Bristol-Myers Squibb BristolMyers Squibb Daiichi Sankyo Daiichi Sankyo Eli Lilly Eli Lilly Merck Merck Momenta Pharmaceuticals Momenta Pharmaceuticals Portola Portola Pozen Pozen Regado Biotechnologies Regado Biotechnologies Sanofi-Aventis SanofiAventis Medicines Company Medicines Company Ortho/McNeill Ortho/McNeill Pfizer Pfizer Polymedix Polymedix Allergan Allergan Sanofi Sanofi Lilly Lilly |
| Identificador |
LANCET NEUROLOGY, NEW YORK, v. 11, n. 4, supl. 1, Part 3, pp. 315-322, APR, 2012 1474-4422 http://www.producao.usp.br/handle/BDPI/42723 10.1016/S1474-4422(12)70042-X |
| Idioma(s) |
eng |
| Publicador |
ELSEVIER SCIENCE INC NEW YORK |
| Relação |
LANCET NEUROLOGY |
| Direitos |
closedAccess Copyright ELSEVIER SCIENCE INC |
| Palavras-Chave | #CLINICAL-TRIALS #SECONDARY PREVENTION #THERAPY #EVENTS #CLINICAL NEUROLOGY |
| Tipo |
article original article publishedVersion |
