Marsh Kassandra, Green David, Raco Veronica, Papadopoulos John, Ahuja Tania
Department of Pharmacy, NYU Langone Health, NY, USA.
Department of Medicine, Division of Hematology, NYU Langone Health, NY, USA.
Ther Adv Cardiovasc Dis. 2020 Jan-Dec;14:1753944720924255. doi: 10.1177/1753944720924255.
Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline.
We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy.
A total of 63 patients [pediatric ( = 6), adult ( = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered.
Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.
重组凝血因子VIIa（rFVIIa）（诺其®）用于逆转抗凝相关出血及心脏手术中的难治性出血。2015年8月，rFVIIa从纽约大学（NYU）朗格尼健康中心的血库转至药房。相应地，制定了一项超说明书用药剂量指南。本研究的目的是描述rFVIIa的使用情况和成本，并评估对我们的剂量指南的依从性。
我们对超说明书用药剂量指南实施后rFVIIa的使用情况进行了回顾性观察研究。对2015年9月至2017年6月期间所有接受rFVIIa治疗的患者进行评估。对于每次rFVIIa给药，收集抗凝和实验室检查值、使用指征、剂量、医嘱和给药时间、伴随的血液制品以及不良事件。不良事件包括静脉血栓栓塞、中风、心肌梗死以及因全身性栓塞和死亡导致的死亡。主要终点是按照超说明书用药剂量指南使用rFVIIa。次要终点包括rFVIIa的止血效果、不良事件、所输注的血液制品以及rFVIIa转至药房的成本效益。
共有63例患者[儿童（n = 6），成人（n = 57）]接受了rFVIIa治疗，大多数用于心脏手术后的难治性出血。超说明书用药剂量指南制定以及从血库转至药房后，rVIIa的使用量有所下降。30天内血栓栓塞事件的总发生率为19.6%；动脉事件占17.6%，静脉事件占2%；70%发生不良事件的患者年龄超过70岁。使用rFVIIa减少了所输注血液制品的中位数单位数。
心脏手术中使用rFVIIa似乎对止血有效。将rFVIIa从血库转至药房并实施剂量指南似乎降低了其使用量。接受rFVIIa治疗的患者应监测血栓栓塞事件。老年患者发生血栓栓塞事件的风险可能更高。
