Effectiveness and safety of apixaban, LMWH, and warfarin among high-risk subgroups of VTE patients with active cancer

Abstract

Objective: 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. Methods: 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 (p < .10) of the interaction between treatment effects and subgroups was evaluated. Results: 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 p ¼ .051) and metastatic diagnosis (interaction p < .001) for recurrent VTE; one significant interactions were observed between apixaban vs. LMWH and cancer treatment for MB (interaction p ¼ .074). Additionally, for warfarin vs. LMWH, two significant interactions were observed between treatment and VTE risk level (interaction p ¼ .005) and metastatic diagnosis (interaction p ¼ .002) for recurrent VTE. Conclusions: Across these high-risk subgroups of VTE cancer patients, treatment outcomes associated with apixaban were generally positive compared to LMWH and warfarin.

Trends in Anticoagulant Utilization and Clinical Outcomes for Cancer-Associated Thrombosis: A Multicenter Cohort Study in Thailand's Upper-Middle–Income Country Setting

“…The present study supports previous observational studies that have shown comparable bleeding rates between DOACs and LMWH, 10 , 12 , 13 thus strengthening the real-world safety of DOACs in Thailand and similar health care settings. Most real-world studies, 13 , 27 including this one, predominantly involve patients treated with rivaroxaban as it is the most used DOACs.…”

“…[6][7][8][9] Real-world studies have also confirmed the comparable effectiveness and safety of DOACs and LMWHs in patients with CAT. [10][11][12][13] It is important to recognize that most trials and real-world studies on CAT treatments, specifically DOACs and LMWH, have primarily been conducted in high-income countries (HICs). [10][11][12][13] This contrasts with upper-middle-income countries (UMICs) like Thailand, which face unique challenges that may hinder the adoption of these recommended treatments.…”

“…[10][11][12][13] It is important to recognize that most trials and real-world studies on CAT treatments, specifically DOACs and LMWH, have primarily been conducted in high-income countries (HICs). [10][11][12][13] This contrasts with upper-middle-income countries (UMICs) like Thailand, which face unique challenges that may hinder the adoption of these recommended treatments. 14 In Thailand, factors such as poor health literacy and poverty can serve as barriers to the effective use of injectable treatments like LMWH.…”

Venous thrombosis during systemic antitumor therapy: risks, prognosis, treatment. A review

“…включены 3393 пациента, которым проводили терапию апиксабаном, 6108 пациентов, которым проводили терапию НМГ, и 4585 пациентов с онкологическими нозологиями, которым проводили терапию варфарином по поводу ВТ. Как и в приведенном метаанализе рандомизированных исследований, данные клинической практики показали, что риск повторных тромботических событий был ниже при применении апиксабана (ОР 0,61, 95% ДИ 0,47-0,81) в сравнении с НМГ, также был ниже риск развития и выраженных кровотечений (ОР 0,63, 95% ДИ 0,47-0,86), в том числе и среди пациентов с опухолями ЖКТ: в группе апиксабана 18,2 на 100 человеко-лет против 23,8 на 100 человеко-лет в группе НМГ (ОР 0,74, 95% ДИ 0,38-1,42; р=0,608) [120].…”