Policy Analysis Inc, Brookline, MA.
Bristol-Myers Squibb, Lawrenceville, NJ.
Blood Adv. 2020 Jan 28;4(2):432-439. doi: 10.1182/bloodadvances.2019001081.
In the phase 3 trial Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy, apixaban was noninferior to enoxaparin, overlapped and followed by warfarin, in the treatment of venous thromboembolism (VTE) with significantly less bleeding; in a real-world evaluation, risks for bleeding and recurrent VTE were lower with apixaban vs warfarin plus parenteral anticoagulant (PAC) bridge therapy. The present study extends this research by comparing outcomes over time and within selected subgroups. A retrospective observational cohort design and 4 US private health care claims databases were used. Study population included patients who initiated outpatient treatment with apixaban or warfarin (plus PAC bridge therapy) for VTE. Major bleeding, clinically relevant nonmajor (CRNM) bleeding, and recurrent VTE were compared during the 180-day follow-up period, at selected follow-up time points (days 21, 90, 180), and within subgroups (pulmonary embolism [PE] with or without deep vein thrombosis [DVT], DVT only, provoked VTE, unprovoked VTE) using multivariable shared frailty models. Study population consisted of 20 561 apixaban patients and 35 080 warfarin patients; baseline characteristics were comparable. Overall, at selected follow-up time points, and within the aforementioned subgroups, adjusted risks were lower among apixaban vs warfarin patients: major bleeding, by 27% to 39%, CRNM bleeding, by 17% to 28%, and recurrent VTE, by 25% to 39% (all P ≤ .01). In this real-world study of VTE patients, risks of bleeding and recurrent VTE were lower among apixaban (vs warfarin) patients during the 180-day follow-up period, at selected follow-up time points, and within subgroups defined by index VTE episode.
在 III 期临床试验 Apixaban 用于肺栓塞和深静脉血栓形成的一线治疗初始管理中，阿哌沙班与重叠并随后用华法林治疗的依诺肝素相比，在治疗静脉血栓栓塞症（VTE）时出血明显减少；在真实世界的评估中，与华法林加静脉抗凝剂（PAC）桥接治疗相比，阿哌沙班的出血和复发性 VTE 风险更低。本研究通过比较随时间推移和在选定亚组内的结果来扩展这项研究。采用回顾性观察队列设计和 4 个美国私人医疗保健索赔数据库。研究人群包括开始门诊治疗 VTE 的阿哌沙班或华法林（加 PAC 桥接治疗）的患者。在 180 天的随访期间、在选定的随访时间点（第 21、90、180 天）以及在亚组（有或无深静脉血栓形成的肺栓塞[PE]、仅深静脉血栓形成、诱发的 VTE、非诱发的 VTE）内，比较了主要出血、临床相关非大出血（CRNM）出血和复发性 VTE，使用多变量共享脆弱性模型。研究人群包括 20561 名阿哌沙班患者和 35080 名华法林患者；基线特征相当。总体而言，在选定的随访时间点以及上述亚组内，与华法林患者相比，阿哌沙班患者的调整风险较低：主要出血降低 27%至 39%、CRNM 出血降低 17%至 28%、复发性 VTE 降低 25%至 39%（所有 P≤0.01）。在这项 VTE 患者的真实世界研究中，在 180 天随访期间、在选定的随访时间点以及根据指数 VTE 发作定义的亚组内，阿哌沙班（与华法林相比）患者的出血和复发性 VTE 风险较低。
