Cohen Alexander T, Keshishian Allison, Lee Theodore, Rosenblatt Lisa, Hlavacek Patrick, Sah Janvi, Luo Xuemei
Department of Hematological Medicine, Guy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.
STATinMED Research, Ann Arbor, MI, USA.
Curr Med Res Opin. 2021 Sep;37(9):1467-1482. doi: 10.1080/03007995.2021.1932448. Epub 2021 Jun 14.
This pooled claims database study evaluated the risk of recurrent Venous Thromboembolism (VTE) and major bleeding (MB) among patients with VTE and active cancer prescribed apixaban, low-molecular weight heparin (LMWH), or warfarin stratified by high-risk subgroups.
Patients diagnosed with VTE in the setting of active cancer who initiated apixaban, LMWH, or warfarin were identified using four US commercial claims databases from 01SEP2014 to the end of the study period (MarketScan: 01MAR2014-30JUNE2017; Optum and Humana: 01MAR2014-31DEC2017; PharMetrics: 01MAR2014-31MAR2018). Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. Cox proportional hazard models were used to evaluate the risk of recurrent VTE and MB for each subgroup stratification: VTE risk level based on cancer types, metastatic diagnosis, cancer treatment, chemotherapy, gastrointestinal cancer, and index VTE event type (PE vs. DVT). Statistical significance ( < .10) of the interaction between treatment effects and subgroups was evaluated.
Eligible subjects included 3393 apixaban, 6108 LMWH, and 4585 warfarin patients. After IPTW, all patient characteristics were balanced. Analyses stratified by the VTE risk level, metastatic diagnosis, cancer treatment, chemotherapy, gastrointestinal cancer and index VTE event type showed generally consistent results according to the respective subgroup (most of the p values for interaction >0.10). Two significant interactions were observed between apixaban vs. LMWH and VTE risk level (interaction = .051) and metastatic diagnosis (interaction < .001) for recurrent VTE; one significant interactions were observed between apixaban vs. LMWH and cancer treatment for MB (interaction = .074). Additionally, for warfarin vs. LMWH, two significant interactions were observed between treatment and VTE risk level (interaction = .005) and metastatic diagnosis (interaction = .002) for recurrent VTE.
Across these high-risk subgroups of VTE cancer patients, treatment outcomes associated with apixaban were generally positive compared to LMWH and warfarin.
这项汇总索赔数据库研究评估了接受阿哌沙班、低分子肝素(LMWH)或华法林治疗的静脉血栓栓塞症(VTE)患者和活动性癌症患者中复发性VTE和大出血(MB)的风险,并按高危亚组进行分层。
利用4个美国商业索赔数据库,从2014年9月1日至研究期结束(MarketScan:2014年3月1日至2017年6月30日;Optum和Humana:2014年3月1日至2017年12月31日;PharMetrics:2014年3月1日至2018年3月31日),识别出在活动性癌症背景下诊断为VTE并开始使用阿哌沙班、LMWH或华法林的患者。采用稳定的逆概率治疗权重(IPTW)来平衡治疗队列。使用Cox比例风险模型评估每个亚组分层中复发性VTE和MB的风险:基于癌症类型、转移诊断、癌症治疗、化疗、胃肠道癌症和首次VTE事件类型(肺栓塞与深静脉血栓形成)的VTE风险水平。评估治疗效果与亚组之间相互作用的统计学显著性(<0.10)。
符合条件的受试者包括3393例阿哌沙班患者、6108例LMWH患者和4585例华法林患者。经过IPTW后,所有患者特征均达到平衡。根据VTE风险水平、转移诊断、癌症治疗、化疗、胃肠道癌症和首次VTE事件类型进行分层分析,结果在各个亚组中总体一致(大多数相互作用的p值>0.10)。在阿哌沙班与LMWH之间,观察到复发性VTE在VTE风险水平(相互作用=0.051)和转移诊断(相互作用<0.001)方面有两个显著的相互作用;在阿哌沙班与LMWH之间,观察到MB在癌症治疗方面有一个显著的相互作用(相互作用=0.074)。此外,对于华法林与LMWH,在复发性VTE的治疗与VTE风险水平(相互作用=0.005)和转移诊断(相互作用= .002)方面观察到两个显著的相互作用。
在这些VTE癌症患者的高危亚组中,与LMWH和华法林相比,阿哌沙班相关的治疗结果总体呈阳性。