Mant Jonathan W F, Richards Suzanne H, Hobbs F D Richard, Fitzmaurice David, Lip Gregory Y H, Murray Ellen, Banting Miriam, Fletcher Kate, Rahman Joy, Allan Teresa, Raftery James, Bryan Stirling
Department of Primary Care & General Practice, University of Birmingham, UK.
BMC Cardiovasc Disord. 2003 Aug 26;3:9. doi: 10.1186/1471-2261-3-9.
Atrial fibrillation (AF) is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly. The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting.
A randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire.1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa). The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular), hospital admissions (all cause, vascular), cognition, quality of life, disability and compliance with study medication.
心房颤动（AF）是中风的一个重要独立危险因素。随机对照试验表明，使用华法林治疗可大幅降低这种风险，而使用阿司匹林治疗则可适度降低风险。现有的华法林疗效试验数据主要来自对特定二级医疗人群的研究，这些人群中老年人的代表性不足。伯明翰老年人心房颤动治疗（BAFTA）研究将提供证据，证明在初级医疗环境中，华法林与阿司匹林预防老年房颤患者中风的风险和益处。
一项随机对照试验，将老年房颤患者随机分为接受调整剂量的华法林或阿司匹林治疗组。患者在随机分组后三个月进行随访，然后由其全科医生此后每六个月随访一次，平均随访三年。患者还将收到一份年度健康问卷。将从英格兰200多家医疗机构招募1240名患者。患者必须年满75岁且患有房颤。如果患者有以下任何一种疾病史，则将被排除：风湿性心脏病；重大非创伤性出血；颅内出血；食管静脉曲张；经内镜证实的活动性消化性溃疡病；对华法林或阿司匹林过敏；或晚期疾病。如果全科医生认为有临床理由优先使用华法林而非阿司匹林治疗患者（反之亦然），则该患者也将被排除。主要终点是致命或非致命性致残性中风（缺血性或出血性）或重大动脉栓塞。次要结果包括重大颅外出血、死亡（各种原因、血管性）、住院（各种原因、血管性）、认知、生活质量、残疾和对研究药物的依从性。
