The randomized study of efficiency and safety of antithrombotic therapy in

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1 .. [ ] mg/d 2 mg/d INR ( 75 INR ) % % 6.0% P =0.03 OR % CI % 62% 1.8% 4.6% P =0.04 OR % CI % 10.6% 5.4% P =0.01 OR % CI P <0.05 [4 1.2% 8 2.2% ] P > % 13.0% P = INR >3.0 INR [ ]

2 The randomized study of efficiency and safety of antithrombotic therapy in nonvalvular atrial fibrillation in Chinese warfarin compared with aspirin Hu Dayi1 Zhang Heping2 Sun Yihong1. The Antithrombotic Therapy in Atrial Fibrillation Investigaters. 1. Cardiology Department of Peking University People s Hospital, , China. 2.Heart Center,Tong Ren Hospital, Beijing , China Abstract Objective To investigate whether warfarin is effective and superior to aspirin in the prevention of thromboembolism in nonvalvular atrial fibrillation in Chinese. Methods In a multicenter, randomized trial, the patients diagnosed as nonvalvular atrail fibrillation were randomized to receive aspirin 150mg-160mg once daily or adjusted-dose warfarin (international normalized ratio 2.0 to 3.0).We compared the effect of the two therapy on the primary end point of ischemic stroke or death from any cause and on the combined end-point stroke death peripheral arteries embolism TIA acute myocardial infarction serious bleeding during a median follow-up period of 18 months Results Of the 704 patients, 420 (60%) were male. Average patient age were year. The median follow-up period is 19 months. The primary end point of death or ischemic stroke was reduced by warfarin,as compared with aspirin (2.7% vs 6.0%, p=0.03, OR % CI ) with the relative risk decreased by 56%. The thromboembolism event in aspirin group was significantly higher than that in warfarin group(5.4% vs 10.6%, P=0.01; OR % CI ) with the relative risk decreased by 52%. There was no significant difference of the mortality rate between the two groups. The secondary end points were nonsignificantly reduced in warfarin group than that in aspirin group, while the combined end point is statistically decreased by adjusted-dose warfarin(8.4% vs13.0% P =0.0047). Warfarin treatment was associated with increased bleeding rate compared to aspirin, although the major bleeding rate is rather low (1.5%). Conclusion Randomized control study demonstrated that anticoagulation with adjusted-dosed warfarin (INR ) can significantly reduced the risk of thromboembolism event

3 with slightly increased hemorrhage, compared to aspirin in Chinese population. All the major bleeding events occurred with INR above 3.0. Under intense monitoring, warfarin is effective and safe for the moderate to high-risk atrial fibrillation patients. Key words Atrial fibrillation Warfarin Aspirin Cerebrovascular accident; Intracranial hemorrhages 5 6 [1] h (1) 2 (2) (3) (4) (5) (6) (7) (8) 180/100 mm Hg 1 mm Hg=0.133 kpa (9) (10) (11) TIA 6 >3.0 mg/dl 3

4 < /ml INR, 2.0 mg/d INR mg INR INR INR mg 1 /d INR TIA CT MRI SPSS 10.0 t 5 Fisher P < % %

5 % mg % % 2.7% 6.0% P =0.03 OR % CI % 1.8% 4.6% P =0.04 OR %CI % 8 2.2%, P > TIA CT MRI [26 7.0% % P =0.46] 8.4% 13.0% p= % 52.0% 10.6% 5.4% P =0.01 OR %CI % % 9 2.4%, P< P< INR >3.0 3 INR % P OR(95%CI) (n=369) (n=335)

6 24 6.0% % % 6 1.8% ( % 4 1.2% ( ) % % % % % % ( ) ( ) 15% 20% 10% 2% [2 3] 6 [4-7] 46% 52% %CI EAFT 0.60 P = P < % 0.9% [8] [9] 56.0% 62.0% 52.0%

7 mg 325 2/3 6.9% 2.4%, P < % [10] [11] 5 INR 3.0 INR 3.0 INR 3.0 INR mg INR

8 1 Arboix A,Lluis GE,Massons JB,et al.atrial fibrillation and stroke:clinical presentation of cardioembolic versus atherothrombotic infarction.int J of Cardiol,2000,73: ,. -., : , : Petersen P, Boysen G, Godtfredsen J, et al. Placebo controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. Lancet, 1989, 1(8631): European Atrial Fibrillation Trial Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet, 1993,342: Stroke Prevention in Atrial Fibrillation Investigators. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: stroke prevention in atrial fibrillation study. Lancet, 1994,343: Gullov AL, Koefoed BG, Petersen P, et al. Fixed mini-dose warfarin and aspirin alone and in combination versus adjusted- dose warfarin for stroke prevention in atrial fibrillation: Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study. Arch Intern Med, 1998,158: , 2003, ,,, Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. The European Atrial Fibrillation Trial Study Group. N Engl J Med,1995, 333:5-10.

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