University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, England.
Service de Cardiologie, Pôle Coeur Thorax Vasculaire, Centre Hospitalier, Universitaire Trousseau et Faculté de Médecine, Université François Rabelais, Tours, France.
Chest. 2014 Sep;146(3):719-726. doi: 10.1378/chest.13-2976.
The efficacy and safety of anticoagulation with use of vitamin K antagonists (VKAs) is highly dependent on the quality of anticoagulation control as reflected by the average time in a therapeutic range of 2.0 to 3.0. A clinical dilemma is trying to predict which anticoagulation-naive patients with atrial fibrillation (AF) would do well on a VKA (with a time in therapeutic range > 70%) and which are less likely to do well on a VKA but could be managed with novel oral anticoagulants.
The cohort comprised 8,120 patients, among whom 4,637 patients were receiving VKA. We investigated whether the SAMe-TT₂R₂ (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]) score could discriminate among patients with AF who were likely to have a labile international normalized ratio (INR) during follow-up as well as stroke/thromboembolism (TE), clinically relevant bleeding (defined as severe bleeding and as Bleeding Academic Research Consortium [BARC]-defined major bleeding), and death while being treated with a VKA.
During a mean follow-up of 1,016 ± 1,108 days, there was a significant increase in risk of severe bleeding events (risk ratio [RR], 1.38; 95% CI, 1.12-2.68; P = .002) and a significant increase in risk of major BARC bleeding (RR, 1.77; 95% CI, 1.29-2.44; P = .0005) in patients with AF with a high SAMe-TT₂R₂ score (> 2). Increasing SAMe-TT₂R₂ score was associated with an increasing risk of labile INR (P = .004), stroke/TE (P = .007), severe bleeding (P < .0001), major BARC bleeding (P < .0001), and death (P = .002) at follow-up. Among the patients taking VKAs, the SAMe-TT₂R₂ score was predictive of labile INR (C statistic approximately 0.58) as well as of stroke/TE, severe bleeding, major BARC bleeding, and death (C statistic, 0.54-0.57 for events), reflecting the suboptimal time in therapeutic range in such patients. This was not the case for patients who were not taking VKAs.
We demonstrate that the SAMe-TT₂R₂ score was predictive for an increasing risk of stroke/TE, severe bleeding, major BARC bleeding, and death, reflecting poor anticoagulation control (and labile INRs) among patients with AF given VKAs.
维生素 K 拮抗剂 (VKA) 的抗凝效果和安全性高度依赖于抗凝控制的质量，反映在治疗范围内的平均时间为 2.0 至 3.0。一个临床难题是试图预测哪些初发房颤 (AF) 患者使用 VKA 效果良好（治疗范围内时间>70%），哪些患者使用 VKA 效果不佳，但可以使用新型口服抗凝剂进行管理。
该队列包括 8120 名患者，其中 4637 名患者正在接受 VKA 治疗。我们研究了 SAMe-TT₂R₂（性别女性、年龄<60 岁、病史[两种以上合并症]、治疗[相互作用药物，如胺碘酮用于节律控制]、烟草使用[加倍]、种族[加倍]）评分是否可以区分在随访期间 INR 不稳定的 AF 患者，以及中风/血栓栓塞 (TE)、临床相关出血（定义为严重出血和 Bleeding Academic Research Consortium [BARC] 定义的大出血）和 VKA 治疗期间的死亡。
在平均 1016±1108 天的随访期间，AF 患者严重出血事件的风险显著增加（风险比 [RR]，1.38；95%CI，1.12-2.68；P=0.002），大出血事件的风险显著增加（RR，1.77；95%CI，1.29-2.44；P=0.0005）。SAMe-TT₂R₂评分较高 (>2) 的患者 INR 不稳定的风险增加（RR，1.38；95%CI，1.12-2.68；P=0.002），中风/TE（RR，1.77；95%CI，1.29-2.44；P=0.0005），严重出血（RR，1.38；95%CI，1.12-2.68；P=0.002），大出血（RR，1.77；95%CI，1.29-2.44；P=0.0005），以及死亡率（RR，1.38；95%CI，1.12-2.68；P=0.002）。在服用 VKAs 的患者中，SAMe-TT₂R₂ 评分可预测 INR 不稳定（C 统计量约为 0.58）以及中风/TE、严重出血、大出血和死亡（C 统计量，0.54-0.57），反映了此类患者治疗范围内的时间不理想。对于未服用 VKAs 的患者则不然。
我们证明，SAMe-TT₂R₂ 评分可预测中风/TE、严重出血、大出血和死亡的风险增加，反映了服用 VKA 的 AF 患者抗凝控制不良（和 INR 不稳定）。
