Al Sulaiman Khalid, Aljohani Manal A, Alharthi Abdullah F, Badreldin Hisham A, Alzahrani Mohammed Y, Alqahtani Rahaf A, Alshahrani Walaa A, Abudayah Fatimah M, Shawaqfeh Mohammad S, Alrashed Ahmed A, Alenazi Alaa M, Alsagri Nouf S, Asiri Mohammed Yahya, Asiri Zayed, Aljarallah Sulaiman, Garwan Yusuf M, Alfehaid Lama S, Alenazi Abeer A, Aldebasi Tariq, Alharbi Shmeylan, Aldemerdash Ahmed, Alzahrani Amer, Aljuhani Ohoud
Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Clin Appl Thromb Hemost. 2025 Jan-Dec;31:10760296251371043. doi: 10.1177/10760296251371043. Epub 2025 Sep 1.
IntroductionAtrial fibrillation (AF) poses a substantial worldwide health concern, significantly increasing the risk of stroke and morbidity. Direct oral anticoagulants (DOACs) such as apixaban are recommended over vitamin K antagonists for the management of AF. However, the impact of thyroid abnormalities on DOACs, specifically apixaban in AF patients remains underexplored. Given the limited data, this study aims to evaluate the effectiveness and safety of apixaban in AF patients with uncontrolled hypothyroidism.MethodsThis study was a retrospective cohort analysis that categorized patients into two sub-cohorts according to their hypothyroidism status at the time they began apixaban treatment: a control group (without hypothyroidism) and an active group (with uncontrolled hypothyroidism). The primary outcome assessed was the rate of thrombosis events following the initiation of apixaban, while bleeding, stroke, and venous thromboembolism (VTE) events were considered as secondary outcomes. Logistic regression analysis was performed, with a p-value of less than .05 deemed statistically significant.ResultsAmong 292 patients included, 51 had uncontrolled hypothyroidism, and 241 were in the control group. Both groups had a median age of 70 years, with predominantly female patients. Any thrombosis events were higher in the uncontrolled hypothyroidism at crude analysis (17.6% vs 8.4%; p-value = .04); as well as higher odds at regression analysis [aOR: 2.40, 95%CI 0.99-5.83; p-value = .05]. In addition, stroke and major bleeding events were significantly higher in the uncontrolled hypothyroidism group (aOR: 4.26, 95%CI 1.51-12.00; p-value = .006 and aOR: 6.21, 95%CI 1.73-22.19; p-value = .005, respectively). The rate of VTE events and minor bleeding did not differ significantly between the two groups.ConclusionsThe use of apixaban in patients with AF and uncontrolled hypothyroidism was linked to higher rates of thrombosis and major bleeding compared to those without known hypothyroidism. These findings highlight the need for further research through larger prospective studies in this often-overlooked population.
引言
心房颤动(AF)是一个全球性的重大健康问题,显著增加了中风和发病风险。对于房颤的治疗,推荐使用阿哌沙班等直接口服抗凝剂(DOACs)而非维生素K拮抗剂。然而,甲状腺异常对DOACs的影响,特别是对房颤患者使用阿哌沙班的影响,仍未得到充分研究。鉴于数据有限,本研究旨在评估阿哌沙班在甲状腺功能减退未得到控制的房颤患者中的有效性和安全性。
方法
本研究为回顾性队列分析,根据患者开始使用阿哌沙班治疗时的甲状腺功能减退状态将患者分为两个亚组:对照组(无甲状腺功能减退)和治疗组(甲状腺功能减退未得到控制)。评估的主要结局是开始使用阿哌沙班后的血栓形成事件发生率,而出血、中风和静脉血栓栓塞(VTE)事件被视为次要结局。进行逻辑回归分析,p值小于0.05被认为具有统计学意义。
结果
在纳入的292例患者中,51例甲状腺功能减退未得到控制,241例为对照组。两组的中位年龄均为70岁,女性患者居多。在粗分析中,甲状腺功能减退未得到控制组的任何血栓形成事件发生率更高(17.6%对8.4%;p值=0.04);在回归分析中也是如此(比值比:2.40,95%置信区间0.99 - 5.83;p值=0.05)。此外,甲状腺功能减退未得到控制组的中风和大出血事件显著更高(比值比:4.26,95%置信区间1.51 - 12.00;p值=0.006和比值比:6.21,95%置信区间1.73 - 22.19;p值=0.005)。两组之间的VTE事件发生率和小出血发生率无显著差异。
结论
与无甲状腺功能减退的患者相比,在甲状腺功能减退未得到控制的房颤患者中使用阿哌沙班与更高的血栓形成和大出血发生率相关。这些发现凸显了在这个经常被忽视的人群中通过更大规模的前瞻性研究进行进一步研究的必要性。