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达比加群和利伐沙班的围手术期管理:抗凝药物停药时间和药物浓度。

Peri-procedural management of dabigatran and rivaroxaban: Duration of anticoagulant discontinuation and drug concentrations.

机构信息

Fondation Rothschild, Service d'Anesthésie-Réanimation, Paris, France; Inserm UMR-S1140, Faculté de Pharmacie, Paris, France.

Inserm UMR-S1140, Faculté de Pharmacie, Paris, France; Hôpital Val de Grâce, Service de Cardiologie, Paris, France.

出版信息

Thromb Res. 2015 Oct;136(4):763-8. doi: 10.1016/j.thromres.2015.08.006. Epub 2015 Aug 14.

DOI:10.1016/j.thromres.2015.08.006
PMID:26319422
Abstract

BACKGROUND

Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

OBJECTIVES

To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal per-procedural [DOAC], defined as [DOAC]<30ng/mL. To investigate the factors associated with per-procedural [DOAC]. To evaluate the ability of normal PT and aPTT to predict [DOAC]<30ng/mL.

METHODS

Patients treated with dabigatran or rivaroxaban, and requiring any invasive procedure were included in this multicentre, prospective, observational study. [DOAC], PT and aPTT were measured during invasive procedure.

RESULTS

Sixty-five patients were enrolled. Duration of DOAC discontinuation ranged from 1-168h. Per-procedural [DOAC] ranged from <30 to 466ng/mL. [DOAC]<30ng/mL occurred more frequently after 48-hour discontinuation than after a shorter delay. [DOAC] remained ≥30ng/mL in 36% and 14% of measurements performed 24-48h and 48h-120h after discontinuation, respectively. According to ROC curve, a cut-off value of 120hours for DOAC discontinuation had a better specificity than a cut-off value of 48hours to predict [DOAC]<30ng/mL. Normal PT and aPTT ratios had good specificity and positive predictive value, but limited sensitivity (74%) and negative predictive value (73%) to predict [DOAC]<30ng/mL.

CONCLUSIONS

A 48-hour discontinuation does not guarantee a [DOAC]<30ng/mL in all patients. Normal PT and aPTT are flawed to predict this threshold and could not replace specific assays. Further studies are needed to define the relationship between per-procedural [DOAC] and clinical outcomes.

摘要

背景

直接口服抗凝剂(DOAC)的围手术期管理具有挑战性。保证手术时 DOAC 浓度([DOAC])最小的术前停药最佳持续时间尚不清楚。通常的 48 小时停药可能对所有患者都不够。

目的

检验以下假设,即 48 小时 DOAC 停药不足以确保最小的围手术期[DOAC],定义为[DOAC]<30ng/mL。研究与围手术期[DOAC]相关的因素。评估正常 PT 和 aPTT 预测[DOAC]<30ng/mL 的能力。

方法

本多中心、前瞻性、观察性研究纳入了接受达比加群或利伐沙班治疗且需要任何侵入性操作的患者。在侵入性操作期间测量[DOAC]、PT 和 aPTT。

结果

共纳入 65 例患者。DOAC 停药时间从 1-168 小时不等。围手术期[DOAC]范围从<30 至 466ng/mL。48 小时停药后比停药时间较短时更频繁地发生[DOAC]<30ng/mL。停药后 24-48 小时和 48-120 小时分别有 36%和 14%的测量值[DOAC]仍≥30ng/mL。根据 ROC 曲线,与 48 小时停药的截止值相比,DOAC 停药 120 小时的截止值预测[DOAC]<30ng/mL 的特异性更好。正常 PT 和 aPTT 比值具有良好的特异性和阳性预测值,但预测[DOAC]<30ng/mL 的敏感性(74%)和阴性预测值(73%)有限。

结论

48 小时停药并不能保证所有患者的[DOAC]<30ng/mL。正常 PT 和 aPTT 预测这一阈值存在缺陷,不能替代特定的检测方法。需要进一步研究以确定围手术期[DOAC]与临床结局之间的关系。

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