新型口服抗凝剂在伴有房颤的肥厚型心肌病患者中的一级卒中预防作用。
Novel Oral Anticoagulants for Primary Stroke Prevention in Hypertrophic Cardiomyopathy Patients With Atrial Fibrillation.
机构信息
From the Department of Internal Medicine, Seoul National University Hospital, Korea (H.-J.L., H.-K.K., H.L., J.-B.P., H.M.K., Y.-J.K.).
Department of Medical Statistics, College of Medicine, Catholic University, Korea (J.-H.J., K.-D.H.).
出版信息
Stroke. 2019 Sep;50(9):2582-2586. doi: 10.1161/STROKEAHA.119.026048. Epub 2019 Jul 25.
Background and Purpose- Hypertrophic cardiomyopathy patients with atrial fibrillation are at increased risk of stroke, and anticoagulation is strongly recommended. However, limited data are available regarding the safety and effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) for primary prevention of stroke. Methods- Using the Korean Health Insurance Review and Assessment Service database, we identified 2397 patients with hypertrophic cardiomyopathy and nonvalvular atrial fibrillation on oral anticoagulation from 2013 to 2016 without history of ischemic stroke, intracranial hemorrhage (ICH), or gastrointestinal bleeding (992 on warfarin and 1405 on NOACs). Inverse probability of treatment weighting with propensity scores was used to balance covariates between treatment groups. Risk for ischemic stroke, ICH, gastrointestinal bleeding, death, and their composite outcome associated with NOAC use was assessed with warfarin use as the reference. Results- During a mean follow-up of 1.6 years, the incidence rates of ischemic stroke, ICH, gastrointestinal bleeding, death, and composite outcome were all significantly lower in the NOAC than in the warfarin group (stroke, 2.8 versus 5.0; ICH, 0.5 versus 1.3; gastrointestinal bleeding, 2.3 versus 3.0; death, 3.0 versus 5.1; composite, 7.5 versus 12.5 events per 100 person-years). NOACs were associated with significantly lower risks of ischemic stroke (hazard ratio [HR], 0.47; 95% CI, 0.32-0.68), ICH (HR, 0.31; 95% CI, 0.14-0.69), gastrointestinal bleeding (HR, 0.62; 95% CI, 0.40-0.96), death (HR, 0.45; 95% CI, 0.31-0.65), and the composite outcome (HR, 0.48; 95% CI, 0.38-0.61) than warfarin. The same trend was observed regardless of the NOAC dose and across various high-risk subgroups. In analysis of individual NOACs, all NOACs were associated with lower risks of ischemic stroke and composite outcome. Conclusions- NOACs showed superior effectiveness and safety versus warfarin in the primary prevention of stroke versus warfarin in real-world Asian hypertrophic cardiomyopathy with atrial fibrillation.
背景与目的-肥厚型心肌病合并心房颤动的患者发生卒中的风险增加，强烈推荐抗凝治疗。然而，有关非维生素 K 拮抗剂口服抗凝剂（NOAC）用于卒中一级预防的安全性和有效性的数据有限。方法-利用韩国健康保险审查与评估服务数据库，我们从 2013 年至 2016 年识别出 2397 例接受口服抗凝治疗的肥厚型心肌病合并非瓣膜性心房颤动且无缺血性卒中和颅内出血（ICH）或胃肠道出血病史的患者（华法林组 992 例，NOAC 组 1405 例）。采用倾向性评分逆概率治疗加权法来平衡两组间的协变量。以华法林为参照，评估 NOAC 与缺血性卒、ICH、胃肠道出血、死亡以及这些复合终点的相关性。结果-在平均 1.6 年的随访期间，NOAC 组的缺血性卒、ICH、胃肠道出血、死亡和复合终点发生率均显著低于华法林组（卒中发生率：2.8% vs. 5.0%；ICH 发生率：0.5% vs. 1.3%；胃肠道出血发生率：2.3% vs. 3.0%；死亡率：3.0% vs. 5.1%；复合终点发生率：每 100 人年 7.5 次 vs. 12.5 次）。NOAC 与缺血性卒（风险比 [HR]，0.47；95%置信区间 [CI]，0.32-0.68）、ICH（HR，0.31；95% CI，0.14-0.69）、胃肠道出血（HR，0.62；95% CI，0.40-0.96）、死亡（HR，0.45；95% CI，0.31-0.65）和复合终点（HR，0.48；95% CI，0.38-0.61）的风险显著降低相关。不论 NOAC 剂量和各种高危亚组，均观察到了相同的趋势。在分析各个 NOAC 时，所有的 NOAC 均与缺血性卒和复合终点的风险降低相关。结论-在亚洲肥厚型心肌病合并心房颤动患者中，与华法林相比，NOAC 在卒中一级预防中具有更好的有效性和安全性。
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