Global Collaboration 39 countries, 1034 sites, 18,201 patients

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.