Bristol-Myers Squibb Company, Lawrenceville, NJ, USA.
Pfizer Inc., New York, NY, USA.
Thromb Res. 2021 Feb;198:163-170. doi: 10.1016/j.thromres.2020.11.039. Epub 2020 Dec 8.
The AMPLIFY trial found significantly lower major bleeding (MB) and similar recurrent venous thromboembolism (VTE) risks associated with apixaban vs warfarin among patients with VTE.
To compare MB, clinically-relevant non-major (CRNM) bleeding, and recurrent VTE risks among clinically-relevant subgroups of newly diagnosed elderly patients with VTE prescribed apixaban vs warfarin.
US Medicare patients prescribed apixaban or warfarin within 30 days post-VTE encounter were identified. Propensity score matching (PSM) was used to control for patient characteristics. Cox models were used to assess MB, CRNM bleeding, and recurrent VTE. Subgroup analyses were conducted for index VTE encounter type, index VTE diagnosis type, index VTE etiology, sex, and frailty.
Post-PSM, 11,363 matched pairs of patients prescribed apixaban or warfarin were identified. Apixaban had lower MB (Hazard Ratio [HR]:0.76; 95% CI:0.64-0.91) and similar recurrent VTE risks (HR:1.04; 95% CI:0.75-1.43) vs warfarin. No significant interactions were observed between treatment and index VTE encounter type, index VTE diagnosis type, or sex for risk of MB, CRNM bleeding, or recurrent VTE. Significant interactions: frail patients prescribed apixaban had a 15% lower, while non-frail patients prescribed apixaban had 32% lower CRNM bleeding risk vs those prescribed warfarin. Patients with provoked VTE prescribed apixaban trended toward a higher, while those with unprovoked VTE trended toward a lower risk of recurrent VTE vs patients prescribed warfarin.
Apixaban was associated with significantly lower risks of MB and CRNM bleeding, and similar risk of recurrent VTE as compared with warfarin across the overall population and most subgroups.
AMPLIFY 试验发现，与华法林相比，新型抗凝药阿哌沙班可显著降低 VTE 患者的大出血（MB）和相似的复发性静脉血栓栓塞症（VTE）风险。
比较阿哌沙班与华法林治疗新诊断的老年 VTE 患者的 MB、临床相关非大出血（CRNM）出血和复发性 VTE 风险。
在美国医疗保险患者中，确定在 VTE 发病后 30 天内使用阿哌沙班或华法林治疗的患者。使用倾向评分匹配（PSM）来控制患者特征。采用 Cox 模型评估 MB、CRNM 出血和复发性 VTE。进行了亚组分析，包括索引 VTE 发作类型、索引 VTE 诊断类型、索引 VTE 病因、性别和脆弱性。
PSM 后，确定了 11363 对接受阿哌沙班或华法林治疗的患者。与华法林相比，阿哌沙班的 MB 风险较低（风险比 [HR]：0.76；95%置信区间：0.64-0.91），且复发性 VTE 风险相似（HR：1.04；95%置信区间：0.75-1.43）。治疗与索引 VTE 发作类型、索引 VTE 诊断类型或性别之间未观察到 MB、CRNM 出血或复发性 VTE 风险的显著交互作用。有显著的相互作用：与华法林相比，阿哌沙班治疗的脆弱患者的 CRNM 出血风险降低 15%，而非脆弱患者的 CRNM 出血风险降低 32%。与华法林相比，有诱发性 VTE 的阿哌沙班治疗患者的复发性 VTE 风险升高，而无诱发性 VTE 的阿哌沙班治疗患者的复发性 VTE 风险降低。
与华法林相比，阿哌沙班在总体人群和大多数亚组中，MB 和 CRNM 出血风险显著降低，复发性 VTE 风险相似。
