Rates of hemorrhage during warfarin therapy for atrial fibrillation
Rates of hemorrhage during warfarin therapy for atrial fibrillation
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DOI：
10.1503/cmaj.121218
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发表时间：
2013-02-05
影响因子：
14.6
通讯作者：
Juurlink, David N.
中科院分区：
文献类型：
--
作者：
Gomes, Tara;Mamdani, Muhammad M.;Juurlink, David N.
背景资料：虽然华法林已在临床试验中进行了广泛的研究，但对其在常规临床实践中的使用导致的出血率知之甚少。我们的目的是检查事件出血事件在一个大的人群为基础的队列的房颤患者开始治疗warfarin.Methods：我们进行了一项基于人群的队列研究，涉及居民的安大略（年龄>= 66岁）与房颤谁开始服用华法林之间1997年4月1日，2008年3月31日。我们将大出血定义为因出血而到医院就诊。我们确定华法林治疗期间出血的粗发生率，总体和按CHADS（2）评分分层（充血性心力衰竭、高血压、年龄≥ 75岁、糖尿病和既往卒中、短暂性脑缺血发作或血栓栓塞）。总体而言，出血率为3.8%（95%置信区间[CI] 3.8%-3.9%）/人-年。大出血的风险在治疗的前30天最高。在此期间，所有患者的出血率为11.8%（95% CI 11.1%-12.5%）/人年，CHADS（2）评分≥ 4的患者为16.7%（95% CI 14.3%-19.4%）/人年。在5年的随访中，10840例（8.7%）患者因出血就诊，其中1963例（18.1%）在出院后7天内死亡。解释：在这个大型老年房颤患者队列中，我们发现华法林治疗的前30天内出血率最高。这些发生率明显高于华法林治疗随机对照试验中报告的1%-3%的发生率。我们的研究提供了华法林相关不良事件的及时估计，这可能对临床医生、患者和政策制定者有用，因为新的治疗选择变得可用。
Background: Although warfarin has been extensively studied in clinical trials, little is known about rates of hemorrhage attributable to its use in routine clinical practice. Our objective was to examine incident hemorrhagic events in a large population-based cohort of patients with atrial fibrillation who were starting treatment with warfarin.Methods: We conducted a population-based cohort study involving residents of Ontario (age >= 66 yr) with atrial fibrillation who started taking warfarin between Apr. 1, 1997, and Mar. 31, 2008. We defined a major hemorrhage as any visit to hospital for hemorrage. We determined crude rates of hemorrhage during warfarin treatment, overall and stratified by CHADS(2) score (congestive heart failure, hypertension, age >= 75 yr, diabetes mellitus and prior stroke, transient ischemic attack or thromboembolism).Results: We included 125 195 patients with atrial fibrillation who started treatment with warfarin during the study period. Overall, the rate of hemorrhage was 3.8% (95% confidence interval [CI] 3.8%-3.9%) per person-year. The risk of major hemorrhage was highest during the first 30 days of treatment. During this period, rates of hemorrhage were 11.8% (95% CI 11.1%-12.5%) per person-year in all patients and 16.7% (95% CI 14.3%-19.4%) per person-year among patients with a CHADS(2) scores of 4 or greater. Over the 5-year follow-up, 10 840 patients (8.7%) visited the hospital for hemorrhage; of these patients, 1963 (18.1%) died in hospital or within 7 days of being discharged.Interpretation: In this large cohort of older patients with atrial fibrillation, we found that rates of hemorrhage are highest within the first 30 days of warfarin therapy. These rates are considerably higher than the rates of 1%-3% reported in randomized controlled trials of warfarin therapy. Our study provides timely estimates of warfarin-related adverse events that may be useful to clinicians, patients and policy-makers as new options for treatment become available.