Kaiser Permanente Colorado Clinical Pharmacy Research Team, Aurora, CO; University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Denver, CO.
Thromb Res. 2013 Aug;132(2):e124-30. doi: 10.1016/j.thromres.2013.06.006. Epub 2013 Jun 22.
This study tests the hypothesis that nonadherence with INR monitoring is associated with an increased risk for warfarin-related bleeding and thrombosis and describes patient characteristics associated with INR monitoring nonadherence.
This was a retrospective, longitudinal, matched cohort study wherein patients were categorized into adherent and nonadherent cohorts; adherent patients were matched 2:1 to nonadherent patients. The primary study endpoint was the first occurrence of bleeding or thromboembolism. Multivariate logistic regression modeling identified patient characteristics associated with INR monitoring adherence or nonadherence.
A total of 4995 and 2544 patients contributed 10729 and 5385 patient-years of warfarin therapy in the adherent and nonadherent groups, respectively. The rate of thromboembolic events during follow up was higher in the nonadherent group than in the adherent group (0.95% vs. 0.62% per patient-year, respectively; p=0.019) and nonadherence to INR monitoring was associated with a moderately higher risk of thromboembolism (adjusted Hazard Ratio=1.51; 95% confidence interval=1.04 - 2.20). The difference in bleeding between the two groups was not statistically significant.
Repeatedly missing INR tests is an easily identified clinical parameter that is associated with moderately increased risk for thromboembolism in patients taking chronic warfarin therapy. Clinicians should carefully consider the underlying thromboembolic risk and extent of nonadherence when weighing the benefits of continued warfarin therapy for a given patient.
本研究旨在检验 INR 监测不依从与华法林相关出血和血栓形成风险增加相关的假设,并描述与 INR 监测不依从相关的患者特征。
这是一项回顾性、纵向、匹配队列研究,将患者分为依从和不依从队列;依从患者与不依从患者以 2:1 的比例匹配。主要研究终点是首次发生出血或血栓栓塞事件。多变量逻辑回归模型确定了与 INR 监测依从或不依从相关的患者特征。
在依从组和不依从组中,分别有 4995 名和 2544 名患者共提供了 10729 名和 5385 名患者年的华法林治疗。在随访期间,不依从组的血栓栓塞事件发生率高于依从组(分别为 0.95%和 0.62%/患者年,p=0.019),并且不依从 INR 监测与血栓栓塞风险中度升高相关(调整后的危险比=1.51;95%置信区间=1.04-2.20)。两组之间的出血差异无统计学意义。
反复错过 INR 检测是一个容易识别的临床参数,与接受慢性华法林治疗的患者中度增加的血栓栓塞风险相关。当权衡继续给予特定患者华法林治疗的益处时,临床医生应仔细考虑潜在的血栓栓塞风险和不依从的程度。