Department of Hematological Medicine, Guy's & St Thomas' NHS Foundation Trust, King's College London, Westminster Bridge Road, London, UK.
STATinMED, LLC, Dallas, TX, USA.
Adv Ther. 2023 Apr;40(4):1705-1735. doi: 10.1007/s12325-023-02440-1. Epub 2023 Feb 22.
Patients at increased risk of bleeding and recurrent VTE who develop venous thromboembolism (VTE) present challenges for clinical management. This study evaluated the effectiveness and safety of apixaban vs warfarin in patients with VTE who have risk factors for bleeding or recurrences.
Adult patients with VTE initiating apixaban or warfarin were identified from five claims databases. Stabilized inverse probability treatment weighting (IPTW) was used to balance characteristics between cohorts for the main analysis. Subgroup interaction analyses were conducted to evaluate treatment effects among patients with and without each of the conditions that increased the risk of bleeding (thrombocytopenia and history of bleed) or recurrent VTE (thrombophilia, chronic liver disease, and immune-mediated disorders).
A total of 94,333 warfarin and 60,786 apixaban patients with VTE met selection criteria. After IPTW, all patient characteristics were balanced between cohorts. Apixaban (vs warfarin) patients were at lower risk of recurrent VTE (HR [95% confidence interval (CI) 0.72 [0.67-0.78]), major bleeding (MB) (HR [95% CI] 0.70 [0.64-0.76]), and clinically relevant non-major (CRNM) bleeding (HR [95% CI] 0.83 [0.80-0.86]). Subgroup analyses showed generally consistent findings with the overall analysis. For most subgroup analyses, there were no significant interactions between treatment and subgroup strata on VTE, MB and CRNM bleeding.
Patients with prescription fills for apixaban had lower risk of recurrent VTE, MB, and CRNM bleeding compared with warfarin patients. Treatment effects of apixaban vs warfarin were generally consistent across subgroups of patients at increased risk of bleeding/recurrences.
有出血和复发性静脉血栓栓塞 (VTE) 风险的患者发生静脉血栓栓塞 (VTE) 时，给临床管理带来了挑战。本研究评估了阿哌沙班与华法林在有出血或复发风险的 VTE 患者中的疗效和安全性。
从五个索赔数据库中确定了开始使用阿哌沙班或华法林的 VTE 成年患者。主要分析采用稳定的逆概率治疗加权（IPT）来平衡队列之间的特征。进行亚组交互分析，以评估在增加出血风险（血小板减少症和出血史）或复发性 VTE（血栓形成倾向、慢性肝病和免疫介导的疾病）的每种情况下的治疗效果。
共有 94333 例华法林和 60786 例阿哌沙班 VTE 患者符合入选标准。经过 IPTW 后，两组患者的所有患者特征均得到平衡。与华法林相比，阿哌沙班（vs 华法林）患者发生复发性 VTE 的风险较低（HR [95%置信区间（CI）] 0.72 [0.67-0.78]），大出血（MB）（HR [95% CI] 0.70 [0.64-0.76]）和临床相关非主要（CRNM）出血（HR [95% CI] 0.83 [0.80-0.86]）。亚组分析显示，总体分析结果基本一致。对于大多数亚组分析，在 VTE、MB 和 CRNM 出血方面，治疗与亚组分层之间没有明显的相互作用。
与华法林患者相比，阿哌沙班处方患者发生复发性 VTE、MB 和 CRNM 出血的风险较低。阿哌沙班与华法林的治疗效果在出血/复发风险增加的患者亚组中基本一致。
