Fong Alan Yean Yip, Tiong Lee Len, Tan Shirley Siang Ning, Geruka Dominic, Apil Gerald Grino, Choo Chee Wei, Ong Tiong Kiam
Clinical Research Center, 58986Sarawak General Hospital, Institute for Clinical Research, National Institutes of Health, Shah Alam, Malaysia.
Department of Cardiology, Sarawak Heart Center, Kota Samarahan, Sarawak, Malaysia.
Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620972473. doi: 10.1177/1076029620972473.
Routine coagulation tests do not enable rapid, accurate determination of direct oral anticoagulant (DOAC) therapy. The ecarin clotting assay (ECA), performed on the ClotPro viscoelastic testing device, may enable sensitive and specific detection of dabigatran. We assessed the association between trough plasma dabigatran concentration and clotting time (CT) in the ClotPro ECA, in patients with non-valvular atrial fibrillation (NVAF). Each patient provided a single venous blood sample, ∼1 hour before dabigatran dosing. The study included 118 patients, of whom 64 were receiving dabigatran 110 mg twice daily and 54 were receiving 150 mg twice daily. ECA CT was moderately correlated with trough plasma dabigatran concentration ( = 0.80, p < 0.001). Slight trends toward increased plasma dabigatran concentration and prolonged ECA CT were apparent with 150 mg versus the 110 mg dose (differences not statistically significant). Individuals with creatinine clearance below 50 mL/minute had significantly higher plasma dabigatran concentrations and significantly prolonged ECA CT versus those with creatinine clearance ≥50 mL/minute. In conclusion, this preliminary study has demonstrated that CT in the ClotPro ECA reflects the plasma concentration of dabigatran in patients with NVAF. The ECA could potentially be used to assess the impact of dabigatran on a patient's coagulation status.
常规凝血试验无法快速、准确地测定直接口服抗凝剂（DOAC）治疗效果。在ClotPro粘弹性检测设备上进行的蛇静脉酶凝血试验（ECA），可能能够灵敏且特异地检测达比加群。我们评估了非瓣膜性心房颤动（NVAF）患者中，ClotPro ECA检测的达比加群谷浓度与凝血时间（CT）之间的关联。每位患者在服用达比加群前约1小时提供一份静脉血样本。该研究纳入了118例患者，其中64例患者每日两次服用110mg达比加群，54例患者每日两次服用150mg达比加群。ECA CT与达比加群谷浓度呈中度相关（ = 0.80，p < 0.001）。与110mg剂量相比，150mg剂量时血浆达比加群浓度升高和ECA CT延长的趋势并不明显（差异无统计学意义）。肌酐清除率低于50mL/分钟的个体，与肌酐清除率≥50mL/分钟的个体相比，血浆达比加群浓度显著更高，ECA CT显著延长。总之，这项初步研究表明，ClotPro ECA中的CT反映了NVAF患者血浆中达比加群的浓度。ECA有可能用于评估达比加群对患者凝血状态的影响。
