Leon H. Charney Division of Cardiology, Department of Medicine, New York University School of Medicine, New York2Veterans Affairs New York Harbor Healthcare System, New York.
Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System, Boston.
JAMA Cardiol. 2016 Apr 1;1(1):65-72. doi: 10.1001/jamacardio.2015.0345.
Traumatic intracranial bleeding, which is most commonly attributable to falls, is a common concern among health care professionals, who are hesitant to prescribe oral anticoagulants to older adults with atrial fibrillation.
To describe the incidence of and risk factors for traumatic intracranial bleeding in a large cohort of older adults who were newly prescribed warfarin sodium.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study at the US Department of Veterans Affairs (VA). Participants included 31 951 veterans with atrial fibrillation 75 years or older who were new referrals to VA anticoagulation clinics (for warfarin therapy) between January 1, 2002, and December 31, 2012. The dates of the core analysis were March 2014 through May 2015, and subsequent ad hoc analyses were performed through December 2015. Patients with comorbid conditions requiring warfarin were excluded.
The primary outcome was hospitalization for traumatic intracranial bleeding. Secondary outcomes included hospitalization for any intracranial bleeding or ischemic stroke. We used International Classification of Diseases, Ninth Revision, Clinical Modification codes to identify the incidence rates of these outcomes after warfarin initiation using VA administrative data (in-system hospitalizations) and Medicare fee-for-service claims data (out-of-system hospitalizations). Clinical characteristics, laboratory results, and pharmacy data were extracted from the VA electronic medical record. For traumatic intracranial bleeding, Cox proportional hazards regression was used to determine predictors of interest selected a priori based on prior known associations.
The study population comprised 31 951 participants. The mean (SD) patient age was 81.1 (4.1) years, and 98.1% were male. Comorbidities were common, including hypertension (82.5%), coronary artery disease (42.6%), and diabetes mellitus (33.8%). During the study period, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1000 person-years. In unadjusted models, significant predictors of traumatic intracranial bleeding included dementia, fall within the past year, anemia, depression, abnormal renal or liver function, anticonvulsant use, labile international normalized ratio, and antihypertensive use. After adjusting for potential confounders, the remaining significant predictors for traumatic intracranial bleeding were dementia (hazard ratio [HR], 1.76; 95% CI, 1.26-2.46), anemia (HR, 1.23; 95% CI, 1.00-1.52), depression (HR, 1.30; 95% CI, 1.05-1.61), anticonvulsant use (HR, 1.35; 95% CI, 1.04-1.75), and labile international normalized ratio (HR, 1.33; 95% CI, 1.04-1.72). The incidence rates of hospitalization for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1000 person-years.
Among patients 75 years or older with atrial fibrillation initiating warfarin therapy, the risk factors for traumatic intracranial bleeding are unique from those for ischemic stroke. The high overall rate of intracranial bleeding in our sample supports the need to more systematically evaluate the benefits and harms of warfarin therapy in older adults.
创伤性颅内出血最常见于跌倒,这是医疗保健专业人员普遍关注的问题,他们在为患有心房颤动的老年人开口服抗凝剂时犹豫不决。
描述在新接受华法林钠治疗的 31951 名年龄在 75 岁及以上的老年患者中,创伤性颅内出血的发生率和危险因素。
设计、地点和参与者:这是在美国退伍军人事务部(VA)进行的回顾性队列研究。参与者包括 31951 名年龄在 75 岁及以上且患有心房颤动的退伍军人,他们在 2002 年 1 月 1 日至 2012 年 12 月 31 日期间首次转诊至 VA 抗凝诊所(接受华法林治疗)。核心分析的日期为 2014 年 3 月至 2015 年 5 月,随后进行了临时分析,直至 2015 年 12 月。患有需要华法林治疗的合并症的患者被排除在外。
主要结局是因创伤性颅内出血而住院。次要结局包括因任何颅内出血或缺血性卒中而住院。我们使用国际疾病分类,第九修订版,临床修正代码,使用 VA 行政数据(系统内住院)和医疗保险费用服务索赔数据(系统外住院)来识别华法林起始后这些结局的发生率。临床特征、实验室结果和药房数据从 VA 电子病历中提取。对于创伤性颅内出血,使用 Cox 比例风险回归来确定根据先前已知关联预先选择的感兴趣的预测因素。
研究人群包括 31951 名参与者。患者的平均(SD)年龄为 81.1(4.1)岁,98.1%为男性。合并症很常见,包括高血压(82.5%)、冠状动脉疾病(42.6%)和糖尿病(33.8%)。在研究期间,因创伤性颅内出血而住院的发生率为每 1000 人年 4.80 例。在未调整模型中,创伤性颅内出血的显著预测因素包括痴呆、过去 1 年内跌倒、贫血、抑郁、肾功能或肝功能异常、抗癫痫药物使用、不稳定的国际标准化比值和抗高血压药物使用。在调整潜在混杂因素后,创伤性颅内出血的其余显著预测因素包括痴呆(风险比[HR],1.76;95%置信区间[CI],1.26-2.46)、贫血(HR,1.23;95% CI,1.00-1.52)、抑郁(HR,1.30;95% CI,1.05-1.61)、抗癫痫药物使用(HR,1.35;95% CI,1.04-1.75)和不稳定的国际标准化比值(HR,1.33;95% CI,1.04-1.72)。因任何颅内出血和缺血性卒中而住院的发生率分别为每 1000 人年 14.58 和 13.44 例。
在开始华法林治疗的 75 岁及以上的心房颤动患者中,创伤性颅内出血的危险因素与缺血性卒中的危险因素不同。我们样本中颅内出血的总体发生率较高,支持更系统地评估华法林治疗在老年人中的获益和危害。