在抗凝服务网络中或作为常规一般护理的患者中使用维生素K拮抗剂治疗的安全性和有效性

G. De Girolamo, L. Sarti, Sonia Cecoli, K. Bonora, C. Ajolfi, F. Bellelli, V. Coluccio, G. Palareti, M. Marietta
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引用次数: 0

摘要

这是一项回顾性的记录链接研究,旨在比较两种维生素K拮抗剂管理模式的有效性和安全性:一种是网络模式(NAS),其中抗凝诊所和全科医生(GP)共享相同的管理软件和数据库,另一种是个体全科医生模式。主要结局为血栓栓塞事件(TE)、大出血(MB)和全因死亡率。计算粗发病率和亚分布风险比。在多变量分析中,采用精细模型和灰色模型计算SHR。纳入了9418名NAS队列患者和5508名常规普通护理(RGC)队列患者。与RGC组相比,NAS组患者TE发病率和死亡率较低(sHR分别为0.76%,95% CI 0.64-0.90和0.82%,95% CI 0.75-0.89)。NAS组比RGC组有更多的患者达到治疗范围内的时间为60% (62.2% vs 35.7%, p<0.001)。两组间MB发病率无统计学差异。本研究表明,NAS模型对维生素K拮抗剂口服抗凝剂管理可显著改善TTR,降低TE发生率和死亡率,而不影响MB率。
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Safety and efficacy of treatment with vitamin K antagonists in patients managed in a network of anticoagulation services or as routine general care
This is a retrospective, record-linkage study aimed at comparing the effectiveness and safety of two management models of vitamin K antagonists: a Network model (NAS), in which anticoagulation clinics and general practitioners (GP) share the same management software and database, and an individual General Practitioners model. Main outcomes were thromboembolic events (TE), major bleeding (MB) and all-cause mortality. Crude incidence rate and sub-distribution hazard ratio were calculated. Fine and Grey models were used to calculate SHR in multi-variable analysis. 9,418 patients in the NAS and 5,508 in the Routine General Care (RGC) cohort were included. Patients in the NAS cohort had a lower incidence of TE and mortality in respect to the RGC (sHR 0.76%, 95% CI 0.64-0.90 and 0.82%, 95% CI 0.75-0.89, respectively). More patients in the NAS than in the RGC cohort attained a Time in Therapeutic Range >60% (62.2% vs 35.7%, p<0.001). No statistically significant difference was found in MB incidence. This study shows that the NAS model for vitamin K antagonist oral anticoagulants management significantly improves the TTR and reduces the incidence of TE and mortality, without affecting the MB rate.
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