Department of Emergency Medicine Pharmacy, University of Colorado Hospital, 12605, E 16th Ave, Aurora, CO, 80045, USA.
Pulmonary and Critical Care Medicine, Intermountain Medical Center, 5121 South Cottonwood St, Murray, UT, 84107, USA.
Neurocrit Care. 2018 Feb;28(1):43-50. doi: 10.1007/s12028-017-0374-y.
Four-factor prothrombin complex concentrates (PCC) produce a more rapid and complete INR correction compared with 3-factor PCC in patients receiving warfarin. It is unknown if this improves clinical outcomes in the setting of intracranial hemorrhage (ICH).
This multicenter, retrospective cohort study included patients presenting with warfarin-associated ICH reversed with either 4- or 3-factor PCC. The primary outcome was in-hospital mortality. Secondary outcomes were 30-day mortality, discharge location, intensive care unit (ICU) and hospital-free days, INR reversal, and thromboembolic (TE) events at 90 days. Each was analyzed using regression analysis. Continuous and binary outcomes were analyzed using linear and logistic regression, respectively, while ordinal regression was used for discharge location.
Of the 103 patients, 63 received 4-factor PCC. Median age was 79 years [interquartile intervals(IQI 73-84)], median presenting INR was 2.7 (2.2-3.3), and presenting ICH was intraparenchymal in 51% of patients. In-hospital and 30-day mortality were 25 and 35%, respectively. In-hospital mortality was greater among those who received 4-factor PCC, yet was not statistically significant (OR 2.2, 95% CI 0.59-9.4, p = 0.26), as having Glasgow Coma Scale (GCS) ≤8 explained most of the difference (OR 48, 95% CI 14-219, p <0.001). The effect of 4-factor PCC was not statistically significant in any of the secondary analyses. Crude rates of TE events were higher in the 4-factor PCC group (19 vs. 10%), though not significantly.
In-hospital mortality was not improved with the use of 4- versus 3-factor PCC in the emergent reversal of warfarin-associated ICH. Secondary clinical outcomes were similarly nonsignificant.
与使用三因子 PCC 相比，四因子 PCC 可使接受华法林治疗的患者更快、更完全地纠正 INR。但目前尚不清楚这是否能改善颅内出血（ICH）患者的临床结局。
本多中心回顾性队列研究纳入了接受四因子或三因子 PCC 逆转治疗的华法林相关性 ICH 患者。主要结局为住院死亡率。次要结局包括 30 天死亡率、出院地点、重症监护病房（ICU）和无住院天数、INR 逆转和 90 天血栓栓塞（TE）事件。采用回归分析对各结局进行分析。连续和二分类结局分别采用线性和逻辑回归进行分析，而对出院地点则采用有序回归进行分析。
在 103 例患者中，63 例患者接受了四因子 PCC 治疗。患者中位年龄为 79 岁[四分位间距（IQR）73-84]，中位初始 INR 为 2.7（2.2-3.3），51%的患者ICH 为脑实质内出血。住院死亡率和 30 天死亡率分别为 25%和 35%。尽管接受四因子 PCC 治疗的患者住院死亡率更高，但差异无统计学意义（OR 2.2，95%CI 0.59-9.4，p=0.26），因为格拉斯哥昏迷量表（GCS）评分≤8 解释了大部分差异（OR 48，95%CI 14-219，p<0.001）。在任何次要分析中，四因子 PCC 的效果均无统计学意义。四因子 PCC 组的 TE 事件粗发生率（19%比 10%）较高，但差异无统计学意义。
在华法林相关性 ICH 的紧急逆转中，与使用三因子 PCC 相比，使用四因子 PCC 并未改善住院死亡率。次要临床结局也同样无显著差异。
