van Elp Margriet, Beinema Maarten, Brouwers Jacobus R B J, van 't Riet Esther, van de Leur Sjef, Schreiber Ildiko, Jansman Frank G A
Department of Clinical Pharmacy, Deventer Hospital, Nico Bolkesteinlaan 75, 7416 SE, Deventer, The Netherlands.
Department of Cardiovascular Medicine, Anticoagulation Centre, Deventer Hospital, Deventer, The Netherlands.
Eur J Clin Pharmacol. 2025 Jul 12. doi: 10.1007/s00228-025-03878-8.
Atrial fibrillation (AF) is common in the elderly population and is associated with a high risk of thromboembolic events. Although non-vitamin K oral anticoagulants (NOACs) are the preferred drugs in antithrombotic therapy for AF, Vitamin K Anticoagulant drug (VKA) treatment is still used in a considerable proportion of patients with AF. Moreover, recent findings revealed that switching VKA to NOAC is associated with more bleeding complications in frail older patients with AF. Standard of care (SOC) monitoring of VKA treatment consists of venous blood sampling and back office dosage advice with a chain of processes and involvement of several health care professionals. We have designed a new procedure for monitoring (Near Patient Therapeutic Monitoring / NPTM) in order to improve the quality and safety of VKA treatment. NPTM consists of INR measurement with a point-of-care (POC) device in the home setting of a patient, performed by one professional and with an instant dosage advice.
This is a cluster-randomised, parallel group, open label study to compare SOC with NPTM of VKA treatment in patients in a home setting. The follow-up period was one year. The primary outcome was time in therapeutic range (TTR), and secondary outcomes were adverse events (deaths, bleeding and thromboembolic events).
555 Patients were included in the study. After randomisation, 271 patients received SOC and 284 patients received NPTM. The TTR did not differ significantly: 63.71% versus 62.47% (p > 0.05) for SOC and NPTM, respectively. Significant differences were found for all-cause death (SOC n = 34 versus NPTM n = 16, p < 0.05, OR 0.47, 95% CI: 0.25-0.87), total number of minor bleedings (79 events in SOC vs 52 in NPTM, p < 0.05, OR 64 (95%CI: 0,37-0,81) and all non-major bleedings (100 events in SOC vs 67 in NPTM, p < 0.05, OR 0.62 (95% CI: 043-0.90).
NPTM of VKA treatment in AF-patients does not result in an improved TTR when compared to SOC. All-cause death, total number of minor bleedings and all non-major bleedings may be reduced in NPTM, although the study was not powered for these secondary outcomes. Future studies are needed to determine the cost-effectiveness of NTPM versus SOC.
心房颤动（AF）在老年人群中很常见，且与血栓栓塞事件的高风险相关。尽管非维生素K口服抗凝剂（NOACs）是AF抗栓治疗的首选药物，但仍有相当一部分AF患者使用维生素K抗凝药物（VKA）治疗。此外，最近的研究发现，在体弱的老年AF患者中，从VKA转换为NOAC会出现更多出血并发症。VKA治疗的标准护理（SOC）监测包括静脉血采样以及后台剂量建议，涉及一系列流程并需要多名医护人员参与。我们设计了一种新的监测程序（患者床边治疗监测/NPTM），以提高VKA治疗的质量和安全性。NPTM包括由一名专业人员在患者家中使用即时检测（POC）设备进行INR测量，并提供即时剂量建议。
这是一项整群随机、平行组、开放标签研究，旨在比较在家中接受VKA治疗的患者的SOC与NPTM。随访期为一年。主要结局是治疗范围内时间（TTR），次要结局是不良事件（死亡、出血和血栓栓塞事件）。
555名患者纳入研究。随机分组后，271名患者接受SOC，284名患者接受NPTM。TTR无显著差异：SOC组和NPTM组分别为63.71%和62.47%（p>0.05）。在全因死亡方面存在显著差异（SOC组n = 34例，NPTM组n = 16例，p<0.05，OR 0.47，95%CI：0.25 - 0.87），轻微出血总数（SOC组79次事件，NPTM组52次事件，p<0.05，OR 64（95%CI：0.37 - 0.81）以及所有非大出血事件（SOC组100次事件，NPTM组67次事件，p<0.05，OR 0.62（95%CI：0.43 - 0.90）。
与SOC相比，AF患者VKA治疗的NPTM并未改善TTR。NPTM可能会降低全因死亡、轻微出血总数和所有非大出血事件的发生率，尽管该研究未针对这些次要结局进行足够的效能分析。未来需要研究来确定NTPM与SOC的成本效益。
