Department of Pharmacy - Houston Methodist Hospital, 6565 Fannin St. DB1-09, Houston, TX, 77030, USA.
Department of Pathology and Genomic Medicine - Houston Methodist Hospital, 6565 Fannin St, Houston, TX, 77030, USA.
J Thromb Thrombolysis. 2021 Jul;52(1):161-169. doi: 10.1007/s11239-020-02308-z. Epub 2020 Oct 24.
Direct factor Xa inhibitors, such as apixaban and rivaroxaban, are widely used for treatment and prevention of venous thromboembolism; however, recent cases of therapeutic failure have been reported. Potential risk factors associated with therapeutic failure such as dose deviations outside of package labeling recommendations, and the use of direct factor Xa-specific inhibitor levels to guide clinical decision making continue to be areas of further investigation. Our study aimed to describe characteristics and dosing regimens in patients on apixaban or rivaroxaban who experienced a new or recurrent thrombosis. We performed a retrospective chart review on 190 patients on either apixaban or rivaroxaban presenting to our institution with new or breakthrough thromboembolism. Evaluation of prescribed anticoagulation regimens compared to package labeling recommendations, direct factor Xa inhibitor-specific anti-Xa levels, anticoagulation interruptions, use of parenteral bridge anticoagulation, final anticoagulation regimen disposition, and thrombosis-associated mortality were recorded. In patients presenting with breakthrough thromboembolism, 78% were on a regimen that matched package labeling recommendations. Anti-Xa levels were documented in 66 patients, the majority of which fell within institutional expected ranges at time of thrombosis. Therapy interruptions immediately prior to thrombosis were observed in 22% of patients and 21% of those patients received parenteral anticoagulation during interruption. Upon discharge, 46% of patients continued the same anticoagulation regimen with no changes. The mortality rate was 6%. In patients who present with new thromboembolism on apixaban or rivaroxaban, a thorough review of risks and benefits should be conducted to mitigate future risk of recurrent thrombosis.
直接因子 Xa 抑制剂,如阿哌沙班和利伐沙班,广泛用于治疗和预防静脉血栓栓塞;然而,最近有治疗失败的病例报告。与治疗失败相关的潜在危险因素,如超出包装标签建议的剂量偏差,以及使用直接因子 Xa 特异性抑制剂水平来指导临床决策,仍然是进一步研究的领域。我们的研究旨在描述在新发性或复发性血栓形成的接受阿哌沙班或利伐沙班治疗的患者的特征和剂量方案。我们对 190 名在我们机构就诊的新发性或突破性血栓形成的接受阿哌沙班或利伐沙班治疗的患者进行了回顾性图表审查。评估了与包装标签建议、直接因子 Xa 抑制剂特异性抗-Xa 水平、抗凝中断、使用肠外桥接抗凝、最终抗凝方案处置以及与血栓形成相关的死亡率相关的处方抗凝方案。在出现突破性血栓形成的患者中,78%的患者使用的方案与包装标签建议相符。在 66 名患者中记录了抗-Xa 水平,其中大多数在血栓形成时处于机构预期范围内。在 22%的患者中观察到在血栓形成之前的治疗中断,其中 21%的患者在中断期间接受了肠外抗凝。出院时,46%的患者继续使用相同的抗凝方案,没有任何变化。死亡率为 6%。在新发性或复发性血栓形成的接受阿哌沙班或利伐沙班治疗的患者中,应进行彻底的风险和效益评估,以降低未来再次发生血栓形成的风险。