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Am Heart J. 2014 Sep;168(3):303-9. doi: 10.1016/j.ahj.2014.06.005. Epub 2014 Jun 6.

Efficacy and safety of apixaban compared with warfarin for stroke prevention in patients with atrial fibrillation from East Asia: a subanalysis of the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

Author information

1
Tokai University School of Medicine, Isehara, Japan. Electronic address: shinichi@is.icc.u-tokai.ac.jp.
2
Fu Wai Hospital, Beijing, China.
3
National Centre of Cardiovascular Disease, Beijing, China.
4
Seoul National University Hospital, Seoul, Korea.
5
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
6
Flinders University, Adelaide, Australia.
7
INECO Neurociencias Oroño, Rosario, Santa Fe, Argentina.
8
Mayo Clinic, Rochester, MN.
9
Bristol-Myers Squibb, Princeton, NJ.
10
Queen Elizabeth Hospital, Woodville South, Australia.
11
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
12
St. John's Medical College and Research Institute, Bangalore, India.

Abstract

BACKGROUND:

The perceived risk of serious bleeding is an obstacle to the use of oral anticoagulation in East Asia. The efficacy and safety of apixaban in East Asian patients with atrial fibrillation are unknown.

METHODS:

ARISTOTLE included 18,201 patients with nonvalvular atrial fibrillation randomized to apixaban 5mg twice daily or warfarin. The efficacy and safety of apixaban and warfarin among patients recruited from East Asia (n = 1,993) were compared with those recruited from outside East Asia (n = 16,208).

RESULTS:

Compared with warfarin, apixaban resulted in a consistent reduction in stroke or systemic embolism in East Asian (hazard ratio [HR] 0.74, 95% CI 0.50-1.10) and non-East Asian (HR 0.81, 95% CI 0.66-0.99) patients (interaction P = .70). Consistent benefits of apixaban over warfarin were also seen for major bleeding in East Asian (HR 0.53, 95% CI 0.35-0.80) and non-East Asian (HR 0.72, 95% CI 0.62-0.83) patients (interaction P = .17). There was a greater reduction in major or clinically relevant nonmajor bleeding with apixaban compared with warfarin in East Asian (HR 0.49, 95% CI 0.35-0.67) than in non-East Asian (HR 0.71, 95% CI 0.63-0.79) patients (interaction P = .03). Numerically higher rates of intracranial bleeding were seen in East Asian patients with warfarin but not with apixaban.

CONCLUSIONS:

Apixaban resulted in similar reductions in stroke or systemic embolism and major bleeding and greater reductions in major or clinically relevant nonmajor bleeding in patients from East Asia. Warfarin is associated with more intracranial bleeding, particularly in patients from East Asia.

PMID:
25173541
DOI:
10.1016/j.ahj.2014.06.005
[Indexed for MEDLINE]

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