Philadelphia College of Pharmacy, University of the Sciences, Philadelphia, PA, USA.
Department of Pharmacy, Cooper University Health Care, Camden, NJ, USA.
J Thromb Thrombolysis. 2022 Jul;54(1):74-81. doi: 10.1007/s11239-021-02613-1. Epub 2021 Nov 26.
The purpose of this study is to assess efficacy of 4-factor prothrombin complex concentrates (4F-PCC) for direct oral anticoagulant (DOAC)-associated intracranial hemorrhage (ICH) as compared to its use in warfarin-associated ICH. A retrospective cohort study was performed to compare the efficacy of 4F-PCC for reversal of apixaban and rivaroxaban versus warfarin for ICH at Cooper University Health Care from January 2015 to December 2019. Patients included were ≥ 18 years of age who developed an ICH while on apixaban, rivaroxaban, or warfarin. The primary outcome was to compare the percentage of patients with Excellent or Good hemostatic efficacy after 4F-PCC administration. Secondary outcomes were to describe functional outcomes at discharge, in-hospital mortality, and thrombotic complications after 4F-PCC administration. A total of 159 patients were included; 115 patients received warfarin and 44 patients received a DOAC (apixaban, n = 22; rivaroxaban, n = 22). 70 patients were evaluable for the primary endpoint. Thirty-four (66.7%) patients in the warfarin group versus 14 (73.7%) patients in the DOAC group were determined to have excellent or good hemostatic efficacy (p = 0.57). In-hospital mortality (30.4% vs. 40.9%, p = 0.21) and thrombotic complications (9.6% vs. 11.4%, p = 0.67) were comparable between the warfarin vs. DOAC groups, respectively. This small, retrospective study found no difference in patients with excellent/good hemostatic efficacy after reversal with 4F-PCC for DOAC-associated ICH compared to warfarin-associated ICH. This study is limited by its retrospective nature and sample size. Larger, prospective studies are needed to further determine the efficacy of 4F-PCC in reversing DOAC-associated ICH.
本研究旨在评估 4 因子凝血酶原复合物浓缩物(4F-PCC)在直接口服抗凝剂(DOAC)相关颅内出血(ICH)中的疗效与其在华法林相关 ICH 中的应用相比。一项回顾性队列研究比较了 2015 年 1 月至 2019 年 12 月库珀大学健康保健中心使用 4F-PCC 逆转依沙班和利伐沙班与华法林治疗 ICH 的疗效。纳入的患者年龄均≥18 岁,在使用依沙班、利伐沙班或华法林期间发生 ICH。主要结局是比较 4F-PCC 给药后患者达到优秀或良好止血效果的比例。次要结局是描述出院时的功能结局、住院死亡率和 4F-PCC 给药后的血栓并发症。共纳入 159 例患者;115 例患者接受华法林治疗,44 例患者接受 DOAC(依沙班,n=22;利伐沙班,n=22)。共有 70 例患者可评估主要终点。华法林组 34 例(66.7%)患者和 DOAC 组 14 例(73.7%)患者被确定为具有优秀或良好止血效果(p=0.57)。住院死亡率(30.4%vs.40.9%,p=0.21)和血栓并发症(9.6%vs.11.4%,p=0.67)在华法林组与 DOAC 组之间相似。这项小型回顾性研究发现,4F-PCC 逆转 DOAC 相关 ICH 与华法林相关 ICH 相比,患者达到优秀/良好止血效果的比例无差异。本研究受其回顾性性质和样本量的限制。需要更大规模的前瞻性研究来进一步确定 4F-PCC 在逆转 DOAC 相关 ICH 中的疗效。