Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada; Faculty of Science, University of Ottawa, Ottawa, Canada.
Department of Medicine, University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada; Faculty of Arts and Science, Queen's University, Kingston, Canada.
Thromb Res. 2022 Aug;216:8-10. doi: 10.1016/j.thromres.2022.05.014. Epub 2022 May 29.
Central venous catheters (CVC) are associated with an increased risk of venous thromboembolism (VTE) in patients with cancer. Primary thromboprophylaxis using a direct oral anticoagulant decreases the risk of VTE in intermediate-to-high risk ambulatory cancer patients. We assessed the efficacy and safety of thromboprophylaxis with apixaban in the subpopulation of patients with cancer and a CVC in the AVERT trial.
The AVERT study was a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban for primary thromboprophylaxis in patients with cancer initiating chemotherapy who were at intermediate to high risk of VTE. The primary efficacy outcome was objectively confirmed VTE within 180 days of randomization and the primary safety outcome was major bleeding. The hazard ratios (HRs) were calculated using a Cox regression model controlling for age, gender, and center.
A total of 217 patients had a CVC and were included in the subgroup analyses with 126 and 91 patients receiving apixaban or placebo, respectively. VTE occurred in 6 (4.8%) patients in the apixaban group and 17 (18.7%) patients in the placebo group (HR 0.26; 95% CI, 0.14-0.47; p < 0.0001). Major bleeding occurred in 2 (1.6%) patients in the apixaban group and 2 (2.2%) patients in the placebo group (HR 0.69; 95% CI, 0.20-2.35; p = 0.556).
Primary thromboprophylaxis with apixaban in patients with cancer and a CVC was associated with a reduced risk of VTE in the AVERT study population, without an increased risk of bleeding. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).
中央静脉导管（CVC）会增加癌症患者发生静脉血栓栓塞症（VTE）的风险。使用直接口服抗凝剂进行初级血栓预防可降低中高危门诊癌症患者发生 VTE 的风险。我们在 AVERT 试验中评估了阿哌沙班在伴有 CVC 的癌症亚人群中的疗效和安全性。
AVERT 研究是一项随机、安慰剂对照、双盲临床试验，评估了阿哌沙班在接受化疗的中高危 VTE 风险癌症患者中的初级血栓预防的疗效和安全性。主要疗效终点是随机分组后 180 天内经客观证实的 VTE，主要安全性终点是大出血。使用 Cox 回归模型控制年龄、性别和中心因素计算危险比（HR）。
共有 217 例患者有 CVC，其中 126 例和 91 例患者分别接受了阿哌沙班和安慰剂，被纳入亚组分析。阿哌沙班组有 6 例（4.8%）患者发生 VTE，安慰剂组有 17 例（18.7%）患者发生 VTE（HR 0.26；95%CI，0.14-0.47；p<0.0001）。阿哌沙班组有 2 例（1.6%）患者发生大出血，安慰剂组有 2 例（2.2%）患者发生大出血（HR 0.69；95%CI，0.20-2.35；p=0.556）。
在 AVERT 研究人群中，伴有 CVC 的癌症患者使用阿哌沙班进行初级血栓预防可降低 VTE 风险，而不会增加出血风险。（由加拿大卫生研究院和百时美施贵宝-辉瑞联盟资助；NCT02048865）。
