Abdelhafiz Ahmed H, Wheeldon Nigel M
Department of Geriatric Medicine, Rotherham General Hospital, Rotherham, United Kingdom.
Clin Ther. 2004 Sep;26(9):1470-8. doi: 10.1016/j.clinthera.2004.09.002.
The goal of this study was to investigate the complications and control of warfarin treatment in patients with nonvalvular atrial fibrillation (NVAF) newly referred to an outpatient anticoagulation clinic.
This study included new patients with NVAF who were referred to an anticoagulation clinic for warfarin therapy over a recruitment period of 21 months. To reflect real-world clinical practice, patient selection for anticoagulation and patient management were left to the referring physicians, who were blinded to their patients' participation in the study. Patients were interviewed in person at the first clinic visit and then by telephone every 4 to 6 weeks. They were questioned about any bleeding or thromboembolic events.
A total of 402 patients were included (100% of all new referrals over 21 months). The mean (SD) age was 72.3 (10.3) years, and 224 (56%) patients were men. The mean (SD) international normalized ratio (INR) was 2.4 (0.31). Patients were followed up for a mean (SD) of 19 (8.1) months (range, 1.0-31.0 months). They spent a mean (SD) 66% (18.3) of time in the target range of INR (ie, 2.0-3.0). Annual event rates were 1.7% (95% CI, 0.4%-3.0%) for major bleeding, 16.6% (95% CI, 13.0%-20.2%) for minor bleeding, 1.2% (95% CI, 0.1%-2.3%) for ischemic stroke, and 0.3% (95% CI, 0.2%-0.8%) for transient ischemic attacks. There were no cases of hemorrhagic stroke or fatal bleeding. Variability of INR and number of medications were identified as risk factors for bleeding (P = 0.03 and P = 0.001, respectively). There was no significant association between age and bleeding.
Based on this analysis, the risks of long-term oral anticoagulation therapy in an outpatient anticoagulation clinic appear to reflect the results of clinical trials. Rates of ischemic stroke, major bleeding, and anticoagulation control were comparable. There was no age-related risk of complications.
本研究旨在调查新转诊至门诊抗凝门诊的非瓣膜性心房颤动（NVAF）患者华法林治疗的并发症及控制情况。
本研究纳入了在21个月招募期内转诊至抗凝门诊接受华法林治疗的新NVAF患者。为反映真实世界的临床实践，抗凝治疗的患者选择及患者管理由转诊医生负责，这些医生对其患者参与研究的情况不知情。患者在首次门诊就诊时接受当面访谈，之后每4至6周通过电话进行随访。询问他们是否发生过任何出血或血栓栓塞事件。
共纳入402例患者（占21个月内所有新转诊患者的100%）。平均（标准差）年龄为72.3（10.3）岁，224例（56%）患者为男性。平均（标准差）国际标准化比值（INR）为2.4（0.31）。患者平均（标准差）随访19（8.1）个月（范围为1.0 - 31.0个月）。他们在INR目标范围（即2.0 - 3.0）内的时间平均（标准差）为66%（18.3）。主要出血的年发生率为1.7%（95%可信区间，0.4% - 3.0%），轻微出血为16.6%（95%可信区间，13.0% - 20.2%），缺血性卒中为1.2%（95%可信区间，0.1% - 2.3%），短暂性脑缺血发作为0.3%（95%可信区间，0.2% - 0.8%）。无出血性卒中或致命性出血病例。INR的变异性和药物数量被确定为出血的危险因素（分别为P = 0.03和P = 0.001）。年龄与出血之间无显著关联。
基于本分析，门诊抗凝门诊长期口服抗凝治疗的风险似乎反映了临床试验的结果。缺血性卒中、主要出血和抗凝控制率具有可比性。不存在与年龄相关的并发症风险。
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