Cardiology Service, Donostia University Hospital, San Sebastián, Guipúzcoa, Spain.
Cardiology Service, Donostia University Hospital, San Sebastián, Guipúzcoa, Spain; Cardiology Service, Bidasoa Hospital, Hondarribia, Guipúzcoa, Spain.
Thromb Res. 2019 Jul;179:20-27. doi: 10.1016/j.thromres.2019.04.023. Epub 2019 Apr 24.
Lack of INR controls might affect the adherence to direct oral anticoagulants (DOAC). The vast majority of studies that addresses adherence to anticoagulants are retrospective and based on pharmacy refill data. Our aim was to compare the adherence between vitamin K antagonists (VKA) and DOAC and to analyze the clinical relevance of non-adherence.
A prospective two-arm observational cohort study was performed in two Spanish public hospitals. Adherence was assessed by Medication Event Monitoring System. Relationship between adherence and events during follow-up and time in therapeutic range (TTR) in the VKA group were analyzed.
257 patients were included (132 DOAC and 125 VKA). Monitoring time was 120 days (101-133). Patients in VKA group showed higher taking adherence (97.9% vs. 95.8%) and less non-adherent patients of >5% and >10% of the doses, without differences in >20% of the doses. Taking adherence was strongly associated with TTR (AUC: 0.89, CI 95%: 0.81-0.97 of TTR for detection of non-adherent patients of >10% of doses). During a follow-up of 1.8 years (1.6-2) non-adherent patients of >5% of doses presented more thromboembolic events (HR 6.1, CI95% 1.3-28.1).
Although adherence to oral anticoagulant therapy was excellent, it was higher to VKA than to DOAC. Time in therapeutic range was highly sensitive to few missed doses of AVK. Non-adherence of >5% of prescribed doses had high clinical relevance.
INR 控制不足可能会影响直接口服抗凝剂（DOAC）的依从性。绝大多数针对抗凝剂依从性的研究都是回顾性的，并且基于药房补充数据。我们的目的是比较维生素 K 拮抗剂（VKA）和 DOAC 的依从性，并分析不依从的临床相关性。
在两家西班牙公立医院进行了一项前瞻性、双臂观察性队列研究。通过药物事件监测系统评估依从性。分析了 VKA 组随访期间和治疗范围内时间（TTR）与事件之间的关系。
共纳入 257 例患者（132 例 DOAC 和 125 例 VKA）。监测时间为 120 天（101-133 天）。VKA 组患者的服药依从性更高（97.9%比 95.8%），不依从率为>5%和>10%的患者更少，但>20%的剂量不依从率无差异。服药依从性与 TTR 密切相关（AUC：TTR 检测>10%剂量不依从患者的 0.89，95%CI：0.81-0.97）。在 1.8 年（1.6-2 年）的随访期间，>5%剂量不依从的患者发生血栓栓塞事件的风险更高（HR 6.1，95%CI95%1.3-28.1）。
尽管口服抗凝治疗的依从性很好，但 VKA 的依从性高于 DOAC。治疗范围内的时间对 AVK 漏服几次剂量非常敏感。不依从>5%的规定剂量具有重要的临床意义。
