Gendron Nicolas, Chocron Richard, Billoir Paul, Brunier Julien, Camoin-Jau Laurence, Tuffigo Marie, Faille Dorothée, Teissandier Dorian, Gay Juliette, de Raucourt Emmanuelle, Suner Ludovic, Bonnet Corentin, Martin Anne-Céline, Lasne Dominique, Ladhari Chayma, Lebreton Aurélien, Bertoletti Laurent, Ajzenberg Nadine, Gaussem Pascale, Morange Pierre-Emmanuel, Le Cam Duchez Véronique, Viallon Alain, Roy Pierre-Marie, Lillo-le Louët Agnès, Smadja David M
Université de Paris, Innovative Therapies in Haemostasis, INSERM, Paris, France.
Hematology Department and Biosurgical Research Lab (Carpentier Foundation), AH-HP, Georges Pompidou European Hospital, Paris, France.
Front Med (Lausanne). 2020 Dec 16;7:599626. doi: 10.3389/fmed.2020.599626. eCollection 2020.
Idarucizumab has been included in guidelines for the management of bleeding or surgical procedure in dabigatran-treated patients without need for biological monitoring. The aim of the study was to assess the prognostic value of dabigatran plasma level before reversal to test the hemostatic efficacy of idarucizumab. The secondary objectives were (i) to analyze plasma dabigatran level according to the risk of rebound and (ii) to evaluate the incidence of post-reversal non-favorable clinical outcomes (including thromboembolism, bleeding, antithrombotic, and death) and antithrombotic resumption. This was an observational multicentric cohort study, which included all French patients who required idarucizumab for dabigatran reversal. Between May 2016 and April 2019, 87 patients from 21 French centers were enrolled. Patients received idarucizumab for overt bleeding ( = 61), urgent procedures ( = 24), or overdose without bleeding ( = 2). Among patients with major bleeding ( = 57), treatment with idarucizumab was considered effective in 44 (77.2%) of them. Patients who did not achieve effective hemostasis after reversal had a significantly higher mean level of plasma dabigatran at baseline (524.5 ± 386 vs. 252.8 ng/mL ± 235, = 0.033). Furthermore, patients who did not achieve effective hemostasis after reversal had less favorable outcomes during follow-up (46.2 vs. 81.8%, = 0.027). ROC curve identified a cutoff of 264 ng/mL for dabigatran level at admission to be predictive of ineffective hemostasis. No plasma dabigatran rebound was observed after reversal in patients with dabigatran plasma level < 264 ng/mL at baseline. This retrospective study shows that dabigatran level before reversal could predict hemostatic effectiveness and dabigatran plasma rebound after idarucizumab injection.
艾达凝血酶原复合物已被纳入达比加群治疗患者出血或外科手术管理指南，无需进行生物监测。本研究的目的是评估达比加群血浆水平在逆转前的预后价值，以测试艾达凝血酶原复合物的止血效果。次要目标是：（i）根据反弹风险分析血浆达比加群水平；（ii）评估逆转后不良临床结局（包括血栓栓塞、出血、抗血栓形成和死亡）及抗血栓恢复的发生率。这是一项观察性多中心队列研究，纳入了所有因达比加群逆转而需要艾达凝血酶原复合物的法国患者。2016年5月至2019年4月期间，来自法国21个中心的87例患者入组。患者因明显出血（n = 61）、紧急手术（n = 24）或无出血的过量用药（n = 2）接受艾达凝血酶原复合物治疗。在主要出血患者（n = 57）中，44例（77.2%）患者接受艾达凝血酶原复合物治疗被认为有效。逆转后未实现有效止血的患者基线时血浆达比加群平均水平显著更高（524.5 ± 386 vs. 252.8 ng/mL ± 235，P = 0.033）。此外，逆转后未实现有效止血的患者随访期间结局较差（46.2% vs. 81.8%，P = 0.027）。ROC曲线确定入院时达比加群水平的截断值为264 ng/mL，可预测止血无效。基线时达比加群血浆水平< 264 ng/mL的患者逆转后未观察到血浆达比加群反弹。这项回顾性研究表明，逆转前的达比加群水平可预测止血效果及艾达凝血酶原复合物注射后达比加群血浆反弹情况。
