Lehto Mika, Niiranen Jussi, Korhonen Pasi, Mehtälä Juha, Khanfir Houssem, Hoti Fabian, Lassila Riitta, Raatikainen Pekka
Department of Cardiology, Heart and Lung Center, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.
EPID Research Oy, Espoo, Finland.
Pharmacoepidemiol Drug Saf. 2017 Jun;26(6):657-665. doi: 10.1002/pds.4194. Epub 2017 Mar 19.
The most important management strategy in atrial fibrillation (AF) patients is preventing stroke with oral anticoagulants. Warfarin is still used as a first-line anticoagulant, although non-vitamin K antagonist oral anticoagulants are currently recommended to manage AF. Using a large, unselected national sample of AF patients, we evaluated the relationships between quality of warfarin therapy and the risks of thromboembolism, bleeding complications, and mortality.
The nationwide FinWAF study included 54 568 AF patients taking warfarin. Time in the therapeutic range (TTR) was calculated on a continuous basis using the Rosendaal method and international normalized ratio values over the previous 60 days. Adjusted Cox proportional hazard models were prepared for different TTR levels and major clinical end points.
The mean age of patients was 73.1 years (standard deviation 10.8), and 47% were female. The mean follow-up time was 3.2 ± 1.6 years (median 3.4). In the TTR groups of ≤40%, 60-70%, 70-80%, and >80%, the annual risk of stroke was 9.3%, 4.7%, 4.6%, and 3.1%; bleeding events 7.5%, 4.5%, 4.3%, and 2.6%; and overall mortality 20.9%, 8.5%, 6.4%, and 3.1%, respectively. All differences among the TTR groups were highly significant (p < 0.001).
The quality of warfarin treatment was strongly associated with the risk of stroke and the prognosis of AF patients. Patient outcomes continued to improve with increasing TTR values up to a TTR ≥80%; therefore, the target for the TTR should exceed 80% instead of the traditional range of at least 60-70%. Copyright © 2017 John Wiley & Sons, Ltd.
心房颤动（AF）患者最重要的管理策略是使用口服抗凝剂预防中风。尽管目前推荐使用非维生素K拮抗剂口服抗凝剂来治疗AF，但华法林仍被用作一线抗凝剂。我们使用一个未经过筛选的大型全国性AF患者样本，评估了华法林治疗质量与血栓栓塞、出血并发症及死亡率风险之间的关系。
全国性的芬兰华法林（FinWAF）研究纳入了54568名服用华法林的AF患者。使用Rosendaal方法并根据前60天的国际标准化比值（INR）值持续计算治疗范围内时间（TTR）。针对不同的TTR水平和主要临床终点建立了调整后的Cox比例风险模型。
患者的平均年龄为73.1岁（标准差10.8），47%为女性。平均随访时间为3.2±1.6年（中位数3.4）。在TTR≤40%、60 - 70%、70 - 80%和>80%的组中，每年的中风风险分别为9.3%、4.7%、4.6%和3.1%；出血事件发生率分别为7.5%、4.5%、4.3%和2.6%；总体死亡率分别为20.9%、8.5%、6.4%和3.1%。TTR组之间的所有差异均具有高度统计学意义（p<0.001）。
华法林治疗质量与中风风险及AF患者的预后密切相关。随着TTR值增加至TTR≥80%，患者的预后持续改善；因此，TTR的目标应超过80%，而非传统的至少60 - 70%的范围。版权所有©2017约翰威立父子有限公司。
