Post on 25-Jan-2016
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S. Goto1, J. Zhu2, L. Lisheng2, BH. Oh3, D. Wojdyla4, M. Hanna5, J. Horowitz6, L. Wallentin7, D. Xavier8, JH. Alexander4
(1) Tokai University School of Medicine, Isehara, Japan (2) Fuwai Hospital, Beijing, China, People's Republic of (3) Seoul National University Hospital, Seoul, Korea, Republic of (4) Duke Clinical Research Institute, Duke University Medical Center, Durham, United States of America (5) Bristol-Myers Squibb, Princeton, United States of America (6) University of Adelaide, Adelaide, Australia (7) Uppsala University, UCR-Uppsala Clinical Research Center, Uppsala, Sweden (8) St. John's Research Institute, Bangolore, India
Efficacy and Safety of Apixaban Compared with Warfarin for Stroke Prevention in Atrial Fibrillation in East Asia with Atrial Fibrillation
Global Collaboration39 countries, 1034 sites, 18,201 patients
Canada: 1057
United States: 3433
Mexico: 609
Finland: 26
Denmark: 339
Hungary: 455
Netherlands: 309
Ukraine: 956
Sweden: 217Norway: 90
U.K.: 434
Belgium: 194
France: 35
Spain: 230
Austria: 34
Italy: 178
Israel: 344
Poland: 314
Czech Rep: 165
Chile: 258
Peru: 213
Colombia: 111
Brazil: 700
Argentina: 1561
South Africa: 89
Russia: 1800
China: 843
India: 601
South Korea: 310
Taiwan: 57
Philippines: 205Malaysia: 126
Singapore: 40
Australia: 322
Germany: 854
Japan: 336
Romania: 274
Turkey: 6
Hong Kong: 76
Bristol-Myers Squibb and Pfizer
1,993 patients were recruited fromEast Asian countries including China (n=843), Japan (n=336), South Korea (n=310), Philippines(n=205), Malaysia (n=126), Hong Kong (n=76) and Singapore (n=40)
Primary Efficacy Endpoint
Primary Safety Endpoint
Primary Safety Endpoint
Conclusion- East Asia vs Non East Asia
• The ARISTOTLE trial enrolled over 1900 patients from East Asian countries. These patients were of lower body weight and tended to have poorer INR control with warfarin.
• Despite similar CHADS2 scores, the overall rate of stroke was higher in East Asian than non-East Asian patients.
• Apixaban had consistent benefits when compared with warfarin on stroke or systemic embolism in East Asian and non-East Asian patients.
• A tendency toward a greater reduction in bleeding was seen with apixaban compared with warfarin in East Asian compared with non-East Asian patients.
• Rates of intracranial bleeding on warfarin were higher in East Asian than non-East Asian patients.
• These data support that apixaban is an attractive alternative to warfarin among East Asian as well as non-East Asian patients with nonvalvular AF.