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未转换为新型口服抗凝药的维生素K拮抗剂治疗的房颤患者的选择、管理及结局。德累斯顿非维生素K拮抗剂口服抗凝药注册研究结果

Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants. Results from the Dresden NOAC registry.

作者信息

Michalski Franziska, Tittl Luise, Werth Sebastian, Hänsel Ulrike, Pannach Sven, Sahin Kurtulus, Weiss Norbert, Beyer-Westendorf Jan

机构信息

Jan Beyer-Westendorf, Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital "Carl Gustav Carus", Technische Universität Dresden, Fetscherstrasse 74, 01307 Dresden, Germany, Tel.: +49 351 4583659, Fax: +49 531 4584359, E-mail:

出版信息

Thromb Haemost. 2015 Nov;114(5):1076-84. doi: 10.1160/TH15-02-0116. Epub 2015 May 21.

Abstract

Atrial fibrillation (AF) patients treated with well-controlled vitamin K antagonists (VKAs) may benefit less from non-vitamin K antagonist oral anticoagulants (NOACs) because they are supposed to be at low risk of thromboembolic and bleeding complications. However, little is known about the selection, management, and outcome of such "stable" VKA patients in current practice. We assessed characteristics, VKA persistence and 12 months' outcome of AF patients selected for VKA continuation. On March 1, 2013, the Dresden NOAC registry opened recruitment of patients continuing on VKA for sites that had been actively recruiting AF patients treated with NOACs in the prior 18 months. Patient characteristics were compared with those of NOAC patients from the same sites. Four hundred twenty-seven VKA patients had a significantly lower bleeding risk profile compared with 706 patients selected for NOAC treatment. For VKA, international normalised ratio time-in-therapeutic range before enrolment was 71 % and increased to 75 % during a mean follow-up of 15 months. Rates of stroke/transient ischaemic attack/systemic embolism were 1.3/100 patient-years (intention-to-treat) and 0.94/100 patient-years (as-treated). On-treatment rate of ISTH major bleeding was 4.15/100 patient-years (95 % CI 2.60-6.29) with a case-fatality rate of 16.3 % (all-cause mortality at day 90 after major bleeding). In conclusion, in daily care, AF patients selected for VKA therapy are healthier than those treated with NOAC, demonstrate a high quality of anticoagulant control and very low stroke rates. However, despite adequate patient selection and INR control, the risk of major VKA bleeding is unacceptably high and bleeding outcome is poor.

摘要

接受良好控制的维生素K拮抗剂(VKA)治疗的心房颤动(AF)患者可能从非维生素K拮抗剂口服抗凝药(NOAC)中获益较少,因为他们被认为发生血栓栓塞和出血并发症的风险较低。然而,在当前临床实践中,对于这类“稳定的”VKA患者的选择、管理及预后情况知之甚少。我们评估了被选择继续使用VKA的AF患者的特征、VKA持续使用情况及12个月的预后。2013年3月1日,德累斯顿NOAC注册研究开始招募在过去18个月中一直在积极招募接受NOAC治疗的AF患者的研究点中继续使用VKA的患者。将患者特征与来自相同研究点的NOAC患者进行比较。与706例被选择接受NOAC治疗的患者相比,427例VKA患者的出血风险特征显著更低。对于VKA,入组前国际标准化比值处于治疗范围内的时间为71%,在平均15个月的随访期间增至75%。卒 中/短暂性脑缺血发作/全身性栓塞的发生率为1.3/100患者年(意向性治疗)和0.94/100患者年(实际治疗)。国际血栓与止血学会(ISTH)定义的大出血的治疗期间发生率为4.15/100患者年(95%CI 2.60 - 6.29),病死率为16.3%(大出血后90天的全因死亡率)。总之,在日常医疗中,被选择接受VKA治疗的AF患者比接受NOAC治疗的患者更健康,抗凝控制质量高且卒中发生率极低。然而,尽管进行了充分的患者选择及国际标准化比值(INR)控制,VKA严重出血的风险仍高得令人难以接受,且出血预后较差。

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