Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia.
Klinikum Darmstadt GmbH, Darmstadt
Haematologica. 2022 Jul 1;107(7):1567-1576. doi: 10.3324/haematol.2021.279072.
The effect of renal impairment (RI) on risk of bleeding and recurrent thrombosis in cancer patients treated with direct oral anticoagulants for venous thromboembolism (VTE) is undefined. We ran a prespecified analysis of the randomized Caravaggio study to evaluate the role of RI as a risk factor for bleeding or recurrence in patients treated with dalteparin or apixaban for cancerassociated VTE. RI was graded as moderate (creatinine clearance between 30-59 mL/minute; 275 patients) and mild (between 60- 89 mL/minute; 444 patients). In the 1142 patients included in this analysis, the incidence of major bleeding was similar in patients with moderate vs. no or mild RI (HR 1.06-95% CI: 0.53-2.11), with no difference in the relative safety of apixaban and dalteparin. Recurrent VTE was not different in moderate vs. no or mild RI (HR=0.67, 95% CI: 0.38-1.20); in moderate RI, apixaban reduced recurrent VTE compared to dalteparin (HR=0.27, 95% CI: 0.08-0.96; P for interaction 0.1085). At multivariate analysis, no association was found between variation of renal function over time and major bleeding or recurrent VTE. Advanced or metastatic cancer was the only independent predictor of major bleeding (HR=2.84, 95% CI: 1.20-6.71), with no effect of treatment with apixaban or dalteparin. In our study, in cancer patients treated with apixaban or dalteparin, moderate RI was not associated with major bleeding or recurrent VTE. In patients with moderate renal failure, the safety profile of apixaban was confirmed with the potential for improved efficacy in comparison to dalteparin. ClinicalTrials.gov identifier: NCT03045406.
肾功能损害（RI）对癌症患者静脉血栓栓塞症（VTE）接受直接口服抗凝剂治疗后出血和复发性血栓形成风险的影响尚不清楚。我们对随机 Caravaggio 研究进行了预设分析，以评估 RI 作为癌症相关 VTE 接受达肝素或阿哌沙班治疗的患者出血或复发的危险因素的作用。RI 分为中度（肌酐清除率 30-59ml/min；275 例患者）和轻度（60-89ml/min；444 例患者）。在本分析纳入的 1142 例患者中，中度 RI 患者与无或轻度 RI 患者的大出血发生率相似（HR 1.06-95%CI：0.53-2.11），阿哌沙班和达肝素的相对安全性无差异。中度 RI 患者与无或轻度 RI 患者的复发性 VTE 无差异（HR=0.67，95%CI：0.38-1.20）；在中度 RI 中，与达肝素相比，阿哌沙班降低了复发性 VTE（HR=0.27，95%CI：0.08-0.96；P 交互 0.1085）。多变量分析显示，肾功能随时间的变化与大出血或复发性 VTE 之间无关联。晚期或转移性癌症是大出血的唯一独立预测因素（HR=2.84，95%CI：1.20-6.71），阿哌沙班或达肝素治疗无影响。在我们的研究中，在接受阿哌沙班或达肝素治疗的癌症患者中，中度 RI 与大出血或复发性 VTE 无关。在中度肾功能衰竭患者中，与达肝素相比，阿哌沙班的安全性得到了证实，并且有可能提高疗效。临床试验.gov 标识符：NCT03045406。
