利伐沙班治疗中国患者有症状的深静脉血栓形成和肺栓塞：EINSTEIN DVT 和 PE 研究的亚组分析。
Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies.
机构信息
Bayer HealthCare, Aprather Weg 18a, Wuppertal D-42096, Germany.
出版信息
Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.
BACKGROUND
The worldwide EINSTEIN DVT and EINSTEIN PE studies randomized 8282 patients with acute symptomatic deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) and, for the first time in trials in this setting, included patients in China. This analysis evaluates the results of these studies in this subgroup of patients.
METHODS
A total of 439 Chinese patients who had acute symptomatic DVT (n=211), or PE with or without DVT (n=228), were randomized to receive rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) or standard therapy of enoxaparin overlapping with and followed by an adjusted-dose vitamin K antagonist, for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or non-major clinically relevant bleeding.
RESULTS
The primary efficacy outcome occurred in seven (3.2%) of the 220 patients in the rivaroxaban group and in seven (3.2%) of the 219 patients in the standard-therapy group (hazard ratio, 1.04; 95% confidence interval 0.36-3.0; p=0.94). The principal safety outcome occurred in 13 (5.9%) patients in the rivaroxaban group and in 20 (9.2%) patients in the standard-therapy group (hazard ratio, 0.63; 95% confidence interval 0.31-1.26; p=0.19). Major bleeding was observed in no patients in the rivaroxaban group and in five (2.3%) patients in the standard-therapy group. In fragile patients (defined as age >75 years, creatinine clearance <50 mL/min, and/or body weight ≤50 kg), the principal safety outcome occurred in four (8.9%) of the 45 patients who received rivaroxaban compared with seven (15.2%) of the 46 patients who received standard therapy.
CONCLUSIONS
In Chinese patients with acute symptomatic DVT and/or PE, rivaroxaban was as efficacious as enoxaparin followed by vitamin K antagonist therapy, with a similar safety profile. The relative efficacy and safety of rivaroxaban compared with enoxaparin/vitamin K antagonist were consistent with that found in the rest of the world.
TRIAL REGISTRATION NUMBER
EINSTEIN PE, ClinicalTrials.gov NCT00439777; EINSTEIN DVT, ClinicalTrials.gov NCT00440193.
背景
全球 EINSTEIN DVT 和 EINSTEIN PE 研究纳入了 8282 例急性有症状深静脉血栓形成（DVT）和/或肺栓塞（PE）患者，这是首次在该领域的试验中纳入中国患者。本分析评估了这些研究在这一亚组患者中的结果。
方法
共有 439 例中国急性有症状 DVT（n=211）或 PE 伴或不伴 DVT（n=228）患者被随机分配接受利伐沙班（15mg 每日 2 次，共 21 天，随后 20mg 每日 1 次）或依诺肝素重叠治疗，随后调整剂量的维生素 K 拮抗剂治疗 3、6 或 12 个月。主要疗效终点是有症状的复发性静脉血栓栓塞症。主要安全性终点是大出血或非大出血临床相关出血。
结果
利伐沙班组 220 例患者中有 7 例（3.2%）发生主要疗效终点事件，标准治疗组 219 例患者中有 7 例（3.2%）发生（风险比，1.04；95%置信区间 0.36-3.0；p=0.94）。利伐沙班组 13 例（5.9%）患者和标准治疗组 20 例（9.2%）患者发生主要安全性终点事件（风险比，0.63；95%置信区间 0.31-1.26；p=0.19）。利伐沙班组无大出血患者，标准治疗组有 5 例（2.3%）患者发生大出血。在脆弱患者（定义为年龄＞75 岁、肌酐清除率＜50ml/min 和/或体重≤50kg）中，利伐沙班组 45 例患者中有 4 例（8.9%）发生主要安全性终点事件，标准治疗组 46 例患者中有 7 例（15.2%）发生（风险比，0.89；95%置信区间 0.40-1.97；p=0.78）。
结论
在中国急性有症状 DVT 和/或 PE 患者中，利伐沙班与依诺肝素联合维生素 K 拮抗剂治疗的疗效相当，安全性相似。与依诺肝素/维生素 K 拮抗剂相比，利伐沙班的相对疗效和安全性与全球其他地区一致。
试验注册
EINSTEIN PE，ClinicalTrials.gov NCT00439777；EINSTEIN DVT，ClinicalTrials.gov NCT00440193。
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