Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ontario, Canada.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Thromb Res. 2021 Jun;202:151-154. doi: 10.1016/j.thromres.2021.03.013. Epub 2021 Mar 21.
Recent trials have demonstrated that thromboprophylaxis using direct oral anticoagulants is effective but associated with a higher rate of major bleeding in intermediate-to-high risk (Khorana score ≥ 2) patients with cancer initiating systemic chemotherapy. Patients with gastrointestinal cancer may be at higher risk of major bleeding complications. We sought to assess the efficacy and safety of using thromboprophylaxis with apixaban in this patient population.
This is a post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind clinical trial. The primary efficacy outcome was objectively documented venous thromboembolism within 180 days of randomization. The primary safety outcome was a major bleeding episode. Time-to-event analyses were performed in patients with gastrointestinal cancers (upper gastrointestinal, pancreatic/hepatobiliary and colorectal cancers).
A total of 130 patients from the original AVERT trial were included, with 65 patients allocated to each of the apixaban and placebo groups. VTE occurred in 3 (4.6%) patients in the apixaban group and 13 (20%) patients in the placebo group (HR: 0.27; 95% CI: 0.13-0.54; p = 0.0002). Major bleeding occurred in 2 (3.1%) patients in the apixaban group and 1 (1.5%) patient in the placebo group (HR 2.39, 95% CI 0.29-19.78, p = 0.42). None of the major bleeding events occurred in patients with upper gastrointestinal or colorectal cancers.
Primary thromboprophylaxis with apixaban therapy seems to be safe and effective in patients with gastrointestinal cancers. Major bleeding complications are uncommon in our cohort. (Funded by the CIHR and Bristol-Myers Squibb-Pfizer Alliance; NCT02048865).
最近的试验表明，在接受系统化疗的中高危（Khorana 评分≥2）癌症患者中，使用直接口服抗凝剂进行血栓预防是有效的，但与更高的大出血发生率相关。患有胃肠道癌症的患者可能有更高的大出血并发症风险。我们旨在评估在这一患者人群中使用阿哌沙班进行血栓预防的疗效和安全性。
这是 AVERT 试验的事后分析，该试验是一项随机、安慰剂对照、双盲临床试验。主要疗效终点是随机分组后 180 天内客观记录的静脉血栓栓塞事件。主要安全性终点是大出血事件。在胃肠道癌（上胃肠道、胰腺/肝胆和结直肠癌）患者中进行了时间至事件分析。
共有 130 名来自原始 AVERT 试验的患者被纳入研究，其中阿哌沙班组和安慰剂组各有 65 名患者。阿哌沙班组有 3 名（4.6%）患者发生 VTE，安慰剂组有 13 名（20%）患者发生 VTE（HR：0.27；95%CI：0.13-0.54；p=0.0002）。阿哌沙班组有 2 名（3.1%）患者发生大出血，安慰剂组有 1 名（1.5%）患者发生大出血（HR 2.39，95%CI 0.29-19.78，p=0.42）。在上胃肠道或结直肠癌患者中均未发生大出血事件。
阿哌沙班治疗的原发性血栓预防似乎在胃肠道癌症患者中安全且有效。在我们的队列中，大出血并发症并不常见。（由加拿大卫生研究院和 Bristol-Myers Squibb-Pfizer 联盟资助；NCT02048865）。
