Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Thromb Res. 2024 Nov;243:109172. doi: 10.1016/j.thromres.2024.109172. Epub 2024 Sep 24.
Factor Xa inhibitor (FXaI)-associated bleeding events are common and associated with substantial morbidity. Systematic evaluation of widely available, effective, and affordable FXaI bleed management strategies is needed.
We conducted a single-center retrospective cohort study of FXaI-treated patients presenting to a tertiary academic medical center from January 2018 to May 2019 who received 25-50 IU/kg 4F-PCC for either FXaI-associated major bleeding or urgent surgery. The primary outcome was hemostatic efficacy, and the safety outcome was the 30-day risk of thromboembolism.
PCC was used to treat FXaI-associated bleeding in 83 cases (79.1 %) and was given before urgent surgery in 22 cases (20.9 %). Sixty-six patients were on apixaban, 38 were on rivaroxaban and one patient was on edoxaban. Intracranial hemorrhage (ICH) and gastrointestinal bleeding accounted for most bleeds (74.7 %). Median interval between last DOAC intake and presentation to triage was 9 h [IQR 5.3-14.8] and median PCC dosing was 40.0 IU/kg [IQR 28.5-46.6]. Forty-two patients (40.0 %) had pre-PCC FXaI levels drawn with median FXaI levels of 114.5 ng/mL [IQR 70.0-175.0]. Effective hemostasis occurred in 66.7 % [95%CI 55.4-76.3] of patients receiving PCC for bleeding and surgical hemostasis was rated as normal in 95.5 % (95%CI 76.5-100.0) for patients having urgent surgery. The 30-day risk of thromboembolism was 7.6 % [95%CI 3.7-14.5] and 22.9 % [95%CI 15.8-31.8] of patients died.
PCC for FXaI-associated bleeding was associated with hemostatic efficacy in two-thirds of patients and thromboembolic events were uncommon. PCC represents a promising treatment strategy for FXaI-associated bleeding.
Xa 因子抑制剂（FXaI）相关出血事件较为常见，且与较高的发病率相关。因此，我们需要对广泛应用的、有效且经济的 FXaI 出血管理策略进行系统评估。
我们进行了一项单中心回顾性队列研究，纳入了 2018 年 1 月至 2019 年 5 月在一所三级学术医疗中心就诊的接受 FXaI 治疗且因 FXaI 相关大出血或紧急手术而接受 25-50 IU/kg 4F-PCC 治疗的患者。主要结局为止血效果，次要结局为 30 天内血栓栓塞风险。
83 例（79.1%）患者因 FXaI 相关出血而使用了 PCC，22 例（20.9%）患者在紧急手术前使用了 PCC。66 例患者接受阿哌沙班治疗，38 例患者接受利伐沙班治疗，1 例患者接受依度沙班治疗。颅内出血（ICH）和胃肠道出血占大多数出血事件（74.7%）。最后一次 DOAC 服用至分诊的中位时间间隔为 9 小时[IQR 5.3-14.8]，PCC 的中位剂量为 40.0 IU/kg[IQR 28.5-46.6]。42 例（40.0%）患者在接受 PCC 治疗前进行了 PCC 前 FXaI 水平检测，中位 FXaI 水平为 114.5 ng/mL[IQR 70.0-175.0]。接受 PCC 治疗出血和手术止血的患者中，66.7%[95%CI 55.4-76.3]的患者止血有效，95.5%[95%CI 76.5-100.0]的患者手术止血正常。30 天内血栓栓塞风险为 7.6%[95%CI 3.7-14.5]，22.9%[95%CI 15.8-31.8]的患者死亡。
PCC 治疗 FXaI 相关出血在三分之二的患者中止血效果显著，血栓栓塞事件较为少见。PCC 是治疗 FXaI 相关出血的一种有前途的治疗策略。
