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May 21, 2019

ESOC-2019

RE-SPECT ESUS, A STUDY OF DABIGATRAN ETEXILATE VERSUS ACETYLSALICYLIC ACID FOR STROKE PREVENTION IN PATIENTS WITH EMBOLIC STROKE OF UNDETERMINED SOURCE: EAST ASIAN SUBGROUP ANALYSIS

;

Uchiyama;

S.;

Toyoda;

K.;

Lee;

B.C.;

Liou;

C.W.;

Ka Sing Wong;

L.;

Cronin;

L.;

Urano;

Y.;

Cotton;

D.;

Diener;

H.C.

esus

stroke prevention

dabigatran

acetylsalicylic acid

clinical trials

Abstract

Abstract

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Keywords

esus

stroke prevention

dabigatran

acetylsalicylic acid

clinical trials

Abstract

Background and Aims: In the Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS) trial, dabigatran was not superior to acetylsalicylic acid (ASA) for the prevention of recurrent stroke. Our prespecified subgroup analysis evaluated results in patients enrolled in East Asia. Methods: Overall, 5390 patients diagnosed with ESUS (564 centres; 42 countries) were randomly assigned to dabigatran (150mg or 110mg twice daily) or ASA and followed up for 0.5–3.5 years. The primary efficacy outcome was time to recurrent stroke. A Cox proportional hazards regression model was used for the analysis of outcomes. Results: Out of 5390 participants, 988 patients were randomized in East Asia (Japan 599, Korea 187, China 109, Taiwan 93). Mean age was 65.3 years, 31.6% were women and the median duration of follow-up was 18.8 months. Efficacy and safety results are shown in the table. The hazard ratios for recurrent stroke and major bleeding (dabigatran vs ASA) were 0.65 (95% CI, 0.41–1.03) and 1.19 (95% CI 0.62–2.30), respectively. Conclusions: In patients with ESUS in East Asia, dabigatran was not superior to ASA in preventing recurrent stroke and did not significantly increase the risk of major bleeding; reflecting the pattern of results observed in the overall study population.

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© Copyright 2019 Morressier GmbH.
All rights reserved.