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Published on: February 26, 2013
Anticoagulation therapy in Chinese patients with non-valvular atrial fibrillation: a prospective, multi-center,
Ke-ping Chen1, Cong-xin Huang, De-jia Huang
1Chinese Academy of Medical Sciences, Beijing, China.
Insights
For Chinese patients with non-valvular atrial fibrillation (NVAF), warfarin therapy (INR 1.6-2.5) significantly reduces thromboembolic events compared to aspirin. While warfarin increased bleeding risk, it proved superior for preventing ischemic strokes and other thromboembolic events in this population.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Non-valvular atrial fibrillation (NVAF) increases ischemic stroke risk.
- Optimal anticoagulation intensity for Chinese NVAF patients remains undetermined.
- This study addresses the need for evidence-based anticoagulation strategies in this demographic.
Purpose of the Study:
- To compare the efficacy and safety of standard-intensity warfarin, low-intensity warfarin, and aspirin.
- To determine the optimal anticoagulation strategy for preventing ischemic events in Chinese NVAF patients.
- To evaluate thromboembolic and hemorrhagic event rates across different anticoagulation therapies.
Main Methods:
- Randomized trial involving 786 Chinese patients across 75 hospitals.
- Three treatment arms: standard-intensity warfarin (INR 2.1-2.5), low-intensity warfarin (INR 1.6-2.0), and aspirin (200 mg/day).
- Long-term follow-up (24 months) with regular clinical evaluations and data collection.
Main Results:
- Warfarin groups showed significantly lower rates of ischemic stroke, TIA, and systemic thromboembolism (2.6%, 3.1%) versus aspirin (6.9%).
- Both warfarin intensities were superior to aspirin (P=0.018, P=0.044) with no significant difference between warfarin groups.
- Higher rates of mild and total hemorrhages observed in warfarin groups (10.2%, 7.6%) compared to aspirin (2.2%) (P=0.001), with no significant difference in severe bleeding or all-cause mortality.
Conclusions:
- Warfarin therapy (INR 1.6-2.5) is more effective than aspirin for preventing thromboembolic events in Chinese NVAF patients.
- Warfarin demonstrates a superior benefit-risk profile for stroke prevention in this population.
- Findings support the use of warfarin for anticoagulation in Chinese patients with NVAF.
Background:
Non-valvular atrial fibrillation is associated with an increased risk of ischemic stroke; however, the appropriate intensity of anticoagulation therapy for Chinese patients has not been determined. The purpose of this study was to compare the safety and the efficacy of standard-intensity warfarin therapy, low-intensity warfarin therapy, and aspirin therapy for the prevention of ischemic events in Chinese patients with non-valvular atrial fibrillation (NVAF).
Methods:
A total of 786 patients from 75 Chinese hospitals were enrolled in this study and randomized into three therapy groups: standard-intensity warfarin (international normalized ratio (INR) 2.1 to 2.5) group, low-intensity warfarin (INR 1.6 to 2.0) group and aspirin (200 mg per day) group. All patients were evaluated by physicians at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after randomization to obtain a patient questionnaire, physical examination and related laboratory tests.
Results:
The annual event rates of ischemic stroke, transient ischemic attack (TIA) or systemic thromboembolism were 2.6%, 3.1% and 6.9% in the standard-intensity warfarin, low-intensity warfarin and aspirin groups, respectively (P = 0.027). Thromboembolic event rates in both warfarin groups were significantly lower than that in the aspirin group (P = 0.018, P = 0.044), and there was no significant difference between the two warfarin groups. Severe hemorrhagic events occurred in 15 patients, 7 (2.6%) in the standard-intensity warfarin group, 7 (2.4%) in the low-intensity warfarin group and 1 (0.4%) in the aspirin group. The severe hemorrhagic event rates in the warfarin groups were higher than that in the aspirin group, but the difference did not reach statistical significance (P = 0.101). The mild hemorrhagic and total hemorrhagic event rates in the warfarin groups (whether in the standard-intensity warfarin group or low-intensity warfarin group) were much higher than that in the aspirin group with the annual event rates of total hemorrhages of 10.2%, 7.6% and 2.2%, respectively, in the 3 groups (P = 0.001). Furthermore, there was no significant difference in all cause mortality among the three study groups.
Conclusion:
In Chinese patients with NVAF, the warfarin therapy (INR 1.6 - 2.5) for the prevention of thromboembolic events was superior to aspirin.
