Asarcikli Lale Dinc, Kafes Habibe, Sen Taner, Ipek Esra Gucuk, Beton Osman, Temizhan Ahmet, Yilmaz Mehmet Birhan
Department of Cardiology, Dr. Siyami Ersek Thoracic Surgery Center, Istanbul, Turkey.
Department of Cardiology, University of Health Sciences, Ankara City Hospital, Ankara, Turkey.
North Clin Istanb. 2022 Mar 10;9(2):93-101. doi: 10.14744/nci.2021.06981. eCollection 2022.
Warfarin therapy has some difficulties in terms of close monitoring and dosage. This study aims to evaluate the effect of same-fixed versus different-variable physician-based monitoring of warfarin therapy on treatment quality and clinical end-points.
A total of 625 consecutive patients requiring warfarin treatment were enrolled at seven centers. INR values of the patients measured at each visit and registered to hospital database were recorded. Time in therapeutic range (TTR) was calculated using linear interpolation method (Rosendaal's method). A TTR value of ≥65% was considered as effective warfarin treatment. If a patient was evaluated by the same-fixed physician at each INR visit, was categorized into the same-physician (SP) group. In contrast, if a patient was evaluated by different-variable physicians at each INR visit, was categorized into variable physician (VP) group. Enrolled patients were followed up for bleeding and embolic events.
One hundred and fifty-six patients (24.9%) were followed by SP group, 469 (75.1%) patients were followed by VP group. Median TTR value of the VP group was lower than that of SP group (56.2% vs. 65.1%, respectively, p=0.009). During median 25.5 months (9-36) of follow-up, minor bleeding, major bleeding and cerebral embolic event rates were higher in VP group compared to SP group (p<0.001, p=0.023, p<0.001, respectively). In multivariate analysis, INR monitoring by VP group was found to be an independent predictor of increased risk of bleeding events (OR 2.55, 95% CI 1.64-3.96, p<0.001) and embolism (OR 3.42, 95% CI 1.66-7.04, p=0.001).
INR monitoring by same physician was associated with better TTR and lower rates of adverse events during follow-up. Hence, it is worth encouraging an SP-based outpatient follow-up system at least for where warfarin therapy is the only choice.
华法林治疗在密切监测和剂量调整方面存在一些困难。本研究旨在评估基于固定同一位医生与不同医生的华法林治疗监测对治疗质量和临床终点的影响。
七个中心共纳入625例连续需要华法林治疗的患者。记录每次就诊时测量并录入医院数据库的患者国际标准化比值(INR)值。采用线性内插法(罗森达尔法)计算处于治疗范围内的时间(TTR)。TTR值≥65%被视为华法林治疗有效。如果患者每次INR就诊均由同一位固定医生评估,则归入同一位医生(SP)组。相反,如果患者每次INR就诊由不同医生评估,则归入不同医生(VP)组。对纳入患者随访出血和栓塞事件。
SP组随访156例患者(24.9%),VP组随访469例患者(75.1%)。VP组的中位TTR值低于SP组(分别为56.2%和65.1%,p = 0.009)。在中位25.5个月(9 - 36个月)的随访期间,VP组的轻微出血、严重出血和脑栓塞事件发生率高于SP组(分别为p < 0.001、p = 0.023、p < 0.001)。多因素分析发现,VP组的INR监测是出血事件风险增加(比值比2.55,95%可信区间1.64 - 3.96,p < 0.001)和栓塞(比值比3.42,95%可信区间1.66 - 7.04,p = 0.001)的独立预测因素。
同一位医生进行INR监测与更好的TTR以及随访期间较低的不良事件发生率相关。因此,至少在华法林治疗是唯一选择的情况下,值得鼓励基于同一位医生的门诊随访系统。