Department of Cardiovascular Diseases, Thrombophilia Clinic, Gonda Vascular Center, Mayo Clinic, Rochester, MN.
Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN.
Mayo Clin Proc. 2019 Jul;94(7):1242-1252. doi: 10.1016/j.mayocp.2018.09.022. Epub 2019 Feb 6.
To compare the clinical efficacy and safety of apixaban with those of rivaroxaban for the treatment of acute venous thromboembolism (VTE).
Consecutive patients enrolled in the Mayo Thrombophilia Clinic Registry (between March 1, 2013, and January 30, 2018) and treated with apixaban or rivaroxaban for acute VTE were followed forward in time. The primary efficacy outcome was VTE recurrence. The primary safety outcome was major bleeding; the second safety outcome was clinically relevant nonmajor bleeding (CRNMB); and the third was a composite of major bleeding or CRNMB.
Within the group of 1696 patients with VTE enrolled, 600 (38%) were treated either with apixaban (n=302, 50%) or rivaroxaban (n=298, 50%) within the first 14 days of VTE diagnosis and who completed at least 3 months of therapy or had a study event. Recurrent VTE was diagnosed in 7 patients (2.3%) treated with apixaban and in 6 (2%) treated with rivaroxaban (adjusted hazard ratio [aHR], 1.4; 95% CI, 0.5-3.8). Major bleeding occurred in 11 patients (3.6%) receiving apixaban and in 9 patients (3.0%) receiving rivaroxaban (aHR, 1.2; 95% CI, 0.5-3.2). Clinically relevant nonmajor bleeding was diagnosed in 7 patients (2.3%) receiving apixaban and in 20 (6.7%) receiving rivaroxaban (aHR, 0.4; 95% CI, 0.2-0.9). The rates of composite major bleeding or CRNMB were similar (aHR, 0.6; 95% CI, 0.3-1.2). Most study events occurred in patients with cancer.
In the setting of a standardized, guideline-directed, patient-oriented clinical practice, the efficacy and safety of apixaban and rivaroxaban for the treatment of acute VTE were comparable.
比较阿哌沙班与利伐沙班治疗急性静脉血栓栓塞症(VTE)的临床疗效和安全性。
连续纳入 2013 年 3 月 1 日至 2018 年 1 月 30 日期间在梅奥血栓形成诊所登记处就诊并接受阿哌沙班或利伐沙班治疗的急性 VTE 患者,随访至时间点。主要疗效终点是 VTE 复发。主要安全性终点是大出血;次要安全性终点是临床相关非大出血(CRNMB);复合终点是大出血或 CRNMB。
在 1696 例 VTE 患者中,600 例(38%)在 VTE 诊断后 14 天内接受阿哌沙班(n=302,50%)或利伐沙班(n=298,50%)治疗,至少完成 3 个月的治疗或发生研究事件。接受阿哌沙班治疗的患者中有 7 例(2.3%)和接受利伐沙班治疗的患者中有 6 例(2%)诊断为复发性 VTE(校正后的危险比[aHR],1.4;95%置信区间[CI],0.5-3.8)。接受阿哌沙班治疗的患者中有 11 例(3.6%)和接受利伐沙班治疗的患者中有 9 例(3.0%)发生大出血(aHR,1.2;95%CI,0.5-3.2)。接受阿哌沙班治疗的患者中有 7 例(2.3%)和接受利伐沙班治疗的患者中有 20 例(6.7%)诊断为临床相关非大出血(aHR,0.4;95%CI,0.2-0.9)。复合终点大出血或 CRNMB 的发生率相似(aHR,0.6;95%CI,0.3-1.2)。大多数研究事件发生在癌症患者中。
在标准化、指南指导、以患者为中心的临床实践环境中,阿哌沙班和利伐沙班治疗急性 VTE 的疗效和安全性相当。