BACKGROUND Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use. METHODS This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding. RESULTS Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60). CONCLUSIONS Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; Caravaggio ClinicalTrials.gov number, NCT03045406.).

中文翻译：

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阿哌沙班用于治疗与癌症相关的静脉血栓栓塞。

背景 最近的指南建议考虑使用口服依度沙班或利伐沙班治疗癌症患者的静脉血栓栓塞。然而，这些口服药物的益处受到与其使用相关的出血风险增加的限制。方法 这是一项多国、随机、研究者发起、开放标签、非劣效性试验，采用盲法中央结果裁决。我们随机分配有症状或偶发性急性近端深静脉血栓形成或肺栓塞的连续癌症患者接受口服阿哌沙班（前 7 天每天两次 10 毫克，随后每天两次 5 毫克）或皮下注射达肝素（第一个月的剂量为每公斤体重 200 IU，每天一次，然后每天一次，每公斤 150 IU）。治疗进行了6个月。主要结果是在试验期间客观证实的复发性静脉血栓栓塞。主要的安全性结果是大出血。结果 阿哌沙班组 576 名患者中的 32 名 (5.6%) 和达肝素组 579 名患者中的 46 名 (7.9%) 发生复发性静脉血栓栓塞（风险比，0.63；95% 置信区间 [CI]，0.37 至 1.07；对于非劣效性，P < 0.001）。阿哌沙班组 22 名患者 (3.8%) 和达肝素组 23 名患者 (4.0%) 发生大出血（风险比，0.82；95% CI，0.40 至 1.69；P = 0.60）。结论 口服阿哌沙班治疗癌症相关静脉血栓栓塞不劣于皮下注射达肝素，且不会增加大出血风险。（由 Bristol-Myers Squibb-Pfizer Alliance 资助；