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London, United Kingdom 2013 Patients with prior stroke/TIA at baseline in RE-LY (randomised set) Patients with prior stroke/TIA at baseline in RE-LY- ABLE (randomised and without treatment discontinuation in RE-LY) Cerebrovasc Dis 2013; 35 (suppl 3)1-854 121 DE 110 mg bid (N = 1195) %/yr DE 150 mg bid (N = 1233) %/yr DE 110 mg bid (N = 619) %/yr DE 150 mg bid (N = 650) %/yr Stroke 2.2 1.9 2.7 2.2 Major bleed 2.7 4.2 3.0 4.3 Major GI bleed 1.2 2.0 1.7 1.8 Death 3.2 4.4 2.7 2.5 3 Stroke prevention A 10:50 - 11:00 Clinical Outcomes of Patients with Previous Transient Ischaemic Attack or Stroke – a Subgroup Analysis of the Long-Term Extension of Dabigatran in Patients with Atrial Fibrillation (RELY-ABLE) Study H.-C. Diener1, L. Wallentin2, M. Brueckmann3, H. Noack4, J. Eikelboom5, M. Ezekowitz6, A. Clemens7, P. Reilly8, S. Yusuf9, S. Connolly10 University Duisberg-Essen, Essen, GERMANY1,Uppsala Clinical Research Centre, Univer-sity Hospital, Uppsala, SWEDEN2, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, GERMANY3, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, GERMANY4, Population Health Research Institute, McMaster University, Hamilton, CANA-DA5, Cardiovascular Research Foundation, New York, USA6, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, GERMANY7, Boehringer Ingelheim Pharmaceuti-cals, Ridgefield, USA8, Population Health Research Institute, McMaster University, Hamilton, CANADA9, Population Health Research Institute, McMaster University, Hamilton, CANADA10 BACKGROUND The RELY-ABLE study, which provides additional double-blind randomized follow-up of pa-tients receiving dabigatran etexilate (DE) after having completed RE-LY, has recently demon-strated that, over the total follow-up of > 4 years, the rates of stroke and major bleeding remain low on DE and are consistent with those seen during RE-LY. The benefits of DE 110 mg and DE 150 mg twice daily in patients who had a previous stroke or transient ischaemic attack (TIA) at baseline in RE-LY were consistent with those of other patients in RE-LY, where DE 150 reduced stroke or systemic embolism and DE 110 was non-inferior compared with warfa-rin. The following analysis examined the subgroup of patients with previous stroke/TIA (when enrolled in or during RE-LY) in their additional follow-up period in the RELY-ABLE study. METHODS Patients were eligible for RELY-ABLE if they were participating in RE-LY, randomized to double-blinded DE and had not permanently discontinued from study medication at the time of the final RE-LY visit. This post hoc sub-analysis comprised patients with previous stroke/TIA at baseline in RE-LY and patients who had stroke/TIA during RE-LY and who continued study treatment. RESULTS Of 5851 patients entering RELY-ABLE, 1269 (21.7%) had previous stroke or TIA. Patients with prior stroke/TIA who entered RELY-ABLE were on average 1.7 years older than respec-tive patients entering RE-LY. Within RELY-ABLE, the annual event rates for major clinical outcomes remained consistent with those in RE-LY for the patient population with prior stroke/ TIA (Table 1). CONCLUSIONS During 2.3 years of additional treatment in RELY-ABLE (total mean follow up of 4.3 years), rates of stroke, major bleeding, major GI bleeding and death in patients with prior stroke or TIA remain low on dabigatran and results observed during the RELY-ABLE follow-up period are consistent with those seen during RE-LY.


Karger_ESC London_2013
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