性别对新诊断非瓣膜性心房颤动患者1年事件发生率的影响：来自GARFIELD-AF注册研究的当代观点
Impact of gender on event rates at 1 year in patients with newly diagnosed non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF registry.
作者信息
Camm A John, Accetta Gabriele, Al Mahmeed Wael, Ambrosio Giuseppe, Goldhaber Samuel Z, Haas Sylvia, Jansky Petr, Kayani Gloria, Misselwitz Frank, Oh Seil, Oto Ali, Raatikainen Pekka, Steffel Jan, van Eickels Martin, Kakkar Ajay K
机构信息
St George's University of London, and Imperial College, London, UK.
Thrombosis Research Institute, London, UK.
出版信息
BMJ Open. 2017 Mar 6;7(3):e014579. doi: 10.1136/bmjopen-2016-014579.
OBJECTIVES
Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) explored the impact of gender, risk factors and anticoagulant (AC) treatment on 1-year outcomes in patients with non-valvular atrial fibrillation (NVAF).
DESIGN
GARFIELD-AF is a prospective non-interventional registry.
SETTING
Investigator sites (n=1048) are representative of the care settings/locations in each of the 35 countries.
PARTICIPANTS
Patients ≥18yrs with newly diagnosed (≤6 weeks' duration) NVAF and ≥1 investigator-determined stroke risk factors.
MAIN OUTCOME MEASURES
Event rates per 100 person-years were estimated from the Poisson model and HRs and 95% CIs calculated.
RESULTS
Of 28 624 patients (women 44.4%; men 55.6%) enrolled, there were more elderly (≥75 years) women (46.9%) than men (30.4%). All-cause mortality rates per 100 person-years (95% CI) for women and men were 4.48 (4.12 to 4.87) and 4.04 (3.74 to 4.38), respectively, stroke/systemic embolism (SE) (1.62 (1.41 to 1.87) and 1.17 (1.01 to 1.36)) and major bleeding (0.93 (0.78 to 1.13) and 0.79 (0.66 to 0.95)). After adjustment for baseline risk factors in treated and untreated patients, HRs (95% CI) for women (relative to men) for stroke/SE rates were 1.3-fold higher in women (HR 1.30 (1.04 to 1.63)), and similar for major bleeding (1.13 (0.85 to 1.50)) and all-cause mortality (1.05 (0.92 to 1.19)). Antithrombotic treatment patterns in men and women were almost identical. 63.8% women and 62.9% men received AC± antiplatelets. Relative to no AC treatment, the reduction in stroke/SE rates with AC treatment was greater (p=0.01) in men (HR 0.45 (0.33 to 0.61)) than women 0.77 (0.57 to 1.03). All-cause mortality reduction with AC treatment was similar (women: 0.65 (0.54 to 0.77); men: 0.57 (0.48 to 0.68)). The risk of major bleeding when treated with AC versus no AC was 2.33 (1.41 to 3.84) in men and 1.86 (1.16 to 2.99) in women (p value=0.53).
CONCLUSIONS
Women have a higher risk of stroke/SE and the reduction in stroke/SE events rates with AC treatment is less in women than in men.
TRIAL REGISTRATION NUMBER
NCT01090362.
目的
FIELD-房颤全球抗凝登记研究（GARFIELD-AF）探讨了性别、危险因素及抗凝治疗对非瓣膜性房颤（NVAF）患者1年预后的影响。
设计
GARFIELD-AF是一项前瞻性非干预性登记研究。
地点
研究站点（n = 1048）代表35个国家中每个国家的医疗环境/地点。
参与者
年龄≥18岁、新诊断（病程≤6周）的NVAF患者，且有≥1个研究者确定的卒中危险因素。
主要观察指标
通过泊松模型估计每100人年的事件发生率，并计算HR及95%CI。
结果
纳入的28624例患者中（女性44.4%；男性55.6%），老年（≥75岁）女性（46.9%）多于男性（30.4%）。女性和男性每100人年的全因死亡率（95%CI）分别为4.48（4.12至4.87）和4.04（3.74至4.38），卒中/全身性栓塞（SE）发生率分别为1.62（1.41至1.87）和1.17（1.01至1.36），大出血发生率分别为0.93（0.78至1.13）和0.79（0.66至0.95）。在对治疗和未治疗患者的基线危险因素进行校正后，女性（相对于男性）卒中/SE发生率的HR（95%CI）高1.3倍（HR 1.30（1.04至1.63））；大出血（1.13（0.85至1.50））和全因死亡率（1.05（0.92至1.19））的HR相似。男性和女性的抗栓治疗模式几乎相同。63.8%的女性和62.9%的男性接受了抗凝剂±抗血小板药物治疗。相对于未进行抗凝治疗，抗凝治疗使男性卒中/SE发生率的降低幅度更大（p = 0.01）（HR 0.45（0.33至0.61）），而女性为0.77（0.57至1.03）。抗凝治疗使全因死亡率的降低幅度相似（女性：0.65（0.54至0.77）；男性：0.57（0.48至0.68））。接受抗凝治疗与未接受抗凝治疗相比，男性大出血风险为2.33（1.41至3.84），女性为1.86（1.16至2.99）（p值 = 0.53）。
结论
女性发生卒中/SE的风险更高，且抗凝治疗使女性卒中/SE事件发生率的降低幅度小于男性。
试验注册号
NCT01090362。
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