Department of Trauma Surgery/Critical Care, Good Samaritan University Hospital, West Islip, New York, USA.
Department of Pediatrics, Graduate Medical Education, Good Samaritan University Hospital, West Islip, New York, USA.
Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241238013. doi: 10.1177/10760296241238013.
Direct oral factor Xa inhibitors are replacing vitamin K-dependent antagonists as anticoagulation treatment in many clinical scenarios. Trauma centers are noting an increase in patients presenting on these medications. The 2018 Food and Drug Administration approval of andexanet alfa provides an alternative anticoagulation reversal. Barriers may limit utilization of new medications including a lack of grade 1A evidence supporting the use of prothrombin complex concentrate (PCC) versus andexanet alfa and cost. To evaluate barriers of andexanet alfa utilization by trauma surgeons, a 15-question survey was conducted. There was a 9% completion rate (n = 89). The results revealed 23.5% would choose andexanet alfa as first-line treatment in children, and 25.8% as first-line treatment in adults. The majority of respondents, 64.7% and 67.4%, would use PCC preferentially in children and adults, respectively. Respondents indicated that cost burden was an overriding factor (76.3%); 42.4% cited lack of high-level efficacy data of andexanet alfa for reversal of factor Xa inhibitors. Additional double-blinded multi-institutional randomized controlled trials comparing 4F-PCC and andexanet alfa for factor Xa inhibitor reversal are needed to support efficacy especially with the increased cost associated.
直接口服因子 Xa 抑制剂正在取代维生素 K 依赖性拮抗剂，成为许多临床情况下的抗凝治疗选择。创伤中心注意到越来越多的患者正在使用这些药物。2018 年，食品和药物管理局批准了andexanet alfa，为抗凝逆转提供了另一种选择。一些障碍可能限制了新药物的使用，包括缺乏支持使用凝血酶原复合物浓缩物（PCC）与 andexanet alfa 的 1A 级证据，以及成本问题。为了评估创伤外科医生对 andexanet alfa 的使用障碍，进行了一项包含 15 个问题的调查。完成率为 9%（n=89）。结果显示，23.5%的受访者会选择 andexanet alfa 作为儿童的一线治疗药物，25.8%的受访者会选择 andexanet alfa 作为成人的一线治疗药物。大多数受访者（64.7%和 67.4%）会分别优先选择 PCC 治疗儿童和成人。受访者表示，成本负担是一个主要因素（76.3%）；42.4%的受访者认为缺乏andexanet alfa 逆转因子 Xa 抑制剂的高等级疗效数据。需要进行更多的双盲多中心随机对照试验，比较 4F-PCC 和 andexanet alfa 用于因子 Xa 抑制剂逆转的疗效，尤其是考虑到与成本相关的问题。
