London, United Kingdom 2013 Recurrent events ≤ 30 days after stroke or TIA by treatment resumption status (no interruption, temporary or per-manent discontinuation) and treatments (DE or warfarin) Cerebrovasc Dis 2013; 35 (suppl 3)1-854 165 No study drug inter-ruption up to 30 days post stroke or TIA Temporary discon-tinuation up to 30 days after stroke or TIA Permanent discontin-uation after stroke or TIA (no restart of medica-tion within 30 days) DE (110+150 bid) % (n/N) Warfa-rin % (n/N) DE (110+150 bid) % (n/N) Warfa-rin % (n/N) DE (110+150 bid) % (n/N) Warfa-rin % (n/N) Death n.a.† n.a.† n.a.† n.a.† 16.4* (26/159) 39.8* (33/83) Stroke 1.3 (2/149) 0.8 (1/121) 3.7 (1/27) 3.3 (1/30) 1.3 (2/159) 2.4 (2/83) TIA 2.0 (3/149) 4.1 (5/121) 0.0 (0/27) 0.0 (0/30) 0.6 (1/159) 0.0 (0/83) Recurrent events > 30 days after stroke or TIA by treatment resumption status (no interruption, temporary or per-manent discontinuation) and treatments (DE or warfarin) No study drug inter-ruption up to 30 days post stroke or TIA Temporary discon-tinuation up to 30 days after stroke or TIA Permanent discontin-uation after stroke or TIA (no restart of medica-tion within 30 days) DE (110+150 bid) % (n/N) Warfa-rin % (n/N) DE (110+150 bid) % (n/N) Warfa-rin % (n/N) DE (110+150 bid) % (n/N) Warfa-rin % (n/N) Death 7.4 (11/149) 11.6 (14/121) 7.4 (2/27) 13.3 (4/30) 11.3 (15/133) 22.0 (11/50) Stroke 4.0 (6/149) 4.1 (5/121) 7.4 (2/27) 6.7 (2/30) 3.8 (5/133) 2.0 (1/50) TIA 4.7 (7/149) 5.8 (7/121) 7.4 (2/27) 3.3 (1/30) 4.5 (6/133) 4.0 (2/50) *p = 0.0001 for mortality after stroke/TIA within 30 days, DE versus warfarin. All other p-val-ues comparing DE and warfarin were n.s. †n.a. = not applicable; cells are empty since death per se leads to permanent discontinuation. 19 Stroke prevention B 17:30 - 17:40 Recurrent Events and Mortality Among Atrial Fibrillation Patients Treated with Dabiga-tran or Warfarin in the RE-LY Trial H.C. Diener1, E. Marijon2, J.-Y. Le Heuzey3, S. Connolly4, H. Noack5, M. Brueckmann6, J. Eikelboom7, M. Ezekowitz8, A. Clemens9, P. Reilly10, L. Wallentin11, S. Yusuf12 on behalf of the RE-LY Investigators University Duisburg-Essen, Essen, GERMANY1,Paris Cardiovascular Research Center and Paris Descartes University and European Georges Pompidou Hospital, Paris, FRANCE2, Paris Descartes University and European Georges Pompidou Hospital, Paris, FRANCE3, Population Health Research Institute, McMaster University, Hamilton, CANADA4, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, GERMANY5, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, GERMANY6, Population Health Research Institute, McMaster University, Hamilton, CANADA7, Cardiovascular Research Foundation, New York, USA8, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, GERMANY9, Boehringer Ingelheim Pharmaceuticals, Ridgefield, USA10, Uppsala Clinical Research Centre, University Hospital, Uppsala, SWEDEN11, Population Health Research Institute, McMaster University, Hamilton, CANADA12 BACKGROUND The RE-LY trial demonstrated the efficacy and favorable safety profile of dabigatran etexilate (DE) compared to warfarin in reducing stroke/systemic embolism incidence in patients with atrial fibrillation. We aimed to explore the impact of study treatment resumption status after a stroke on recurrent event or death rates within 30 days and after 30 days, when prophylactic treatment usually has been restarted. METHODS This post-hoc analysis evaluated recurrent events and death after a first stroke or transient isch-emic attack (TIA) on study treatment (i.e. safety set), according to use or restart of study med-ication within 30 days after the event. We analyzed recurrent events that occurred within 30 days and those > 30 days after the first event until end of study of treatment (+ 6 days) or end of study period. Fisher’s exact test was used to compare post-stroke/TIA recurrence rates between the combined DE arms (150 + 110 mg bid) and warfarin. RESULTS Among the 18,040 patients who received study medication (mean follow-up 2 years), 569 pa-tients had a stroke or TIA: 189 receiving DE 110, 146 DE 150, and 234 warfarin. Irrespective of continuation, temporary or permanent discontinuation of study medication there were no sig-nificant differences in rates of recurrent stroke/TIA for DE vs warfarin within 30 days or there-after (Table). Mortality rates were similar for DE and warfarin in patients continuing or tempo-rarily discontinuing study medication. The 30-day mortality after stroke/TIA was significantly lower (p = 0.0001) with DE (16.4%) than with warfarin (39.8%), but only numerically lower in patients who survived the 30 days after stroke/TIA. Recurrent event rates were similar between DE 110 and 150. CONCLUSIONS After a stroke or TIA there is no increased risk for recurrence with DE vs warfarin irrespective of anticoagulant study treatment status after the event. Furthermore, the 30-day mortality in pa-tients with stroke or TIA is higher with warfarin than with DE.
Karger_ESC London_2013
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