Azimi Saeed, Hajifathali Abbas, Parkhideh Sayeh, Salamzadeh Jamshid, Rahmati-Kamel Bardia, Dastan Farzaneh, Mehdizadeh Mahshid, Abiyarghamsari Mahdiye, Tavakoli-Ardakani Maria
Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hematopoietic Stem Cell Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Iran J Pharm Res. 2024 Feb 21;23(1):e143213. doi: 10.5812/ijpr-143213. eCollection 2024 Jan-Dec.
Hematopoietic stem cell transplantation (HSCT) patients are at risk of thromboembolic events, making thromboprophylaxis crucial.
This study aimed to compare apixaban, a direct factor Xa inhibitor (DOAC), with dalteparin and unfractionated heparin for thromboprophylaxis in HSCT recipients. The safety outcome included the assessment of hemorrhagic events.
In this open-label randomized clinical trial, 182 HSCT recipients were divided into three groups: Apixaban (n = 61, 2.5 mg two times a day), dalteparin (n = 59, 5000 IU daily), and unfractionated heparin (n = 62, 5000 IU twice daily). These anticoagulant regimens were administered after central vein catheterization and during hospitalization. The primary clinical outcome was the risk of thrombosis, and the secondary outcome was the rate of bleeding. Relevant laboratory results were analyzed using appropriate statistical tests.
Among the 61 patients in the apixaban group, six experienced thrombosis (9.83%), with four (6.65%) of them on anticoagulants. In the dalteparin group, three patients (5%) developed thrombosis, two of whom (3.38%) were on anticoagulants. In the heparin group, all four thrombosis cases (6.4%) occurred in patients on anticoagulants (P = 0.543 overall and P = 0.776 in anticoagulant users). Only two cases of bleeding were reported (1.09% overall), one in the dalteparin group (1.69%) and the other in the apixaban group (1.63%).
Apixaban, dalteparin, and heparin demonstrated similar effectiveness in preventing thromboembolism in HSCT recipients. Furthermore, the comparison of bleeding rates across the study groups did not reveal significant differences. Larger studies with higher event rates may yield more precise conclusions.
造血干细胞移植（HSCT）患者有发生血栓栓塞事件的风险，因此血栓预防至关重要。
本研究旨在比较直接Xa因子抑制剂（DOAC）阿哌沙班与达肝素和普通肝素在HSCT受者血栓预防中的效果。安全结局包括对出血事件的评估。
在这项开放标签随机临床试验中，182名HSCT受者被分为三组：阿哌沙班组（n = 61，每日两次，每次2.5 mg）、达肝素组（n = 59，每日5000 IU）和普通肝素组（n = 62，每日两次，每次5000 IU）。这些抗凝方案在中心静脉置管后及住院期间使用。主要临床结局是血栓形成风险，次要结局是出血率。使用适当的统计检验分析相关实验室结果。
在阿哌沙班组的61例患者中，6例发生血栓（9.83%），其中4例（6.65%）正在接受抗凝治疗。在达肝素组中，3例患者（5%）发生血栓，其中2例（3.38%）正在接受抗凝治疗。在肝素组中，所有4例血栓形成病例（6.4%）均发生在接受抗凝治疗的患者中（总体P = 0.543，抗凝治疗使用者中P = 0.776）。仅报告了2例出血病例（总体1.09%），1例在达肝素组（1.69%），另1例在阿哌沙班组（1.63%）。
阿哌沙班、达肝素和肝素在预防HSCT受者血栓栓塞方面显示出相似的有效性。此外，各研究组出血率的比较未发现显著差异。进行事件发生率更高的更大规模研究可能会得出更精确的结论。
