Department of Hematology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
Groningen Research Institute of Pharmacy, Unit of Pharmacotherapy, Epidemiology and Economy, University of Groningen, Groningen, The Netherlands.
Thromb Haemost. 2024 Aug;124(8):778-790. doi: 10.1055/a-2168-9378. Epub 2023 Sep 6.
Current guideline suggests a switch from vitamin K antagonist (VKA) to direct oral anticoagulant (DOAC) in patients with low time in therapeutic range (TTR < 70%). Poor international normalized ratio (INR) control may be the result of poor compliance, and might therefore be associated with subsequent DOAC intake. Therefore, this study evaluates the effect of previous TTR and other measures of INR control on DOAC nonadherence and nonpersistence, in patients who switched from VKA to DOAC.
A total of 437 patients who switched from VKA to DOAC between 2012 and 2019 were included using data from Certe Thrombosis Service, IADB.nl pharmacy community database University Groningen, and Statistics Netherlands. DOAC prescriptions were used to determine nonadherence and nonpersistence. INR control (i.e., TTR, time under therapeutic range [TUR], and INR variability) was assessed during the last 180 days of VKA use. Multivariable regression models were applied to determine the association between INR control and DOAC nonpersistence/nonadherence.
On VKA, 67.7% of the patients had a TTR below 70%. DOAC nonpersistence was 39.8% (95% confidence interval [CI]: 33.4-45.5%) during a median follow-up of 34.4 months (interquartile range: 19.1-49.2). Approximately 80% of persistent patients were DOAC-adherent. Low TTR was not associated with DOAC nonpersistence (hazard ratio: 1.14, 95% CI: 0.69-1.87) and DOAC nonadherence (odds ratio: 1.38, 95% CI: 0.67-2.84), nor were TUR and INR variability.
Previous INR control during VKA therapy is not associated with subsequent DOAC nonadherence and nonpersistence. This study suggests that INR control on VKA cannot, and therefore should not, be used for predicting DOAC adherence or persistence.
目前的指南建议，对于治疗范围内时间（TTR＜70%）较低的患者，从维生素 K 拮抗剂（VKA）转换为直接口服抗凝剂（DOAC）。国际标准化比值（INR）控制不佳可能是由于依从性差所致，因此可能与随后的 DOAC 摄入有关。因此，本研究评估了先前 TTR 和其他 INR 控制措施对从 VKA 转换为 DOAC 的患者的 DOAC 不依从和不持续的影响。
共纳入了 2012 年至 2019 年期间从 VKA 转换为 DOAC 的 437 例患者，数据来自 Certe Thrombosis Service、IADB.nl 药房社区数据库、格罗宁根大学和荷兰统计局。通过 DOAC 处方确定不依从和不持续情况。在 VKA 使用的最后 180 天内评估 INR 控制（即 TTR、治疗范围内时间 [TUR] 和 INR 变异性）。应用多变量回归模型确定 INR 控制与 DOAC 不持续/不依从之间的关联。
在 VKA 治疗期间，67.7%的患者 TTR 低于 70%。在中位随访 34.4 个月（四分位距：19.1-49.2）期间，DOAC 不持续率为 39.8%（95%置信区间：33.4-45.5%）。约 80%的持续患者是 DOAC 依从者。低 TTR 与 DOAC 不持续（风险比：1.14，95%置信区间：0.69-1.87）和 DOAC 不依从（优势比：1.38，95%置信区间：0.67-2.84）无关，TUR 和 INR 变异性也无关。
VKA 治疗期间先前的 INR 控制与随后的 DOAC 不依从和不持续无关。本研究表明，VKA 上的 INR 控制不能也不应该用于预测 DOAC 的依从性或持续性。
