Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness
Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness
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DOI：
10.1056/nejmoa1805090
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发表时间：
2018-09-20
影响因子：
158.5
通讯作者：
Kaatz, Scott
中科院分区：
文献类型：
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作者：
Spyropoulos, Alex C.;Ageno, Walter;Kaatz, Scott
背景因内科疾病住院的患者在出院后仍然面临静脉血栓栓塞症的风险，但延长血栓预防在此类患者治疗中的作用仍是一个有争议的主题。方法在这项随机、双盲试验中，根据国际静脉血栓栓塞症(改善)评分为4或更高(评分范围从0到10，在出院时，将患者分为两组，一组为静脉血栓栓塞症风险较高的利伐沙班组，另一组为血浆n-二聚体水平高于正常范围上限两倍(根据当地实验室标准定义)的组，另一组为利伐沙班每日一次，剂量10毫克(根据肾功能不全调整剂量)或安慰剂45天。主要的疗效结果是有症状的静脉血栓栓塞症或因静脉血栓栓塞症而死亡。结果在12,024名接受随机分组的患者中，12,019人进入意向治疗分析。在服用利伐沙班的6007名患者中有50名(0.83%)出现了主要疗效结果，而在6012名服用安慰剂的患者中有66名(1.10%)发生了主要疗效结局(风险比0.76；95%可信区间[CI]0.52至1.09；P=0.14)。在有症状的非致命性静脉血栓栓塞症中，利伐沙班组和安慰剂组分别有0.18%和0.42%的患者出现预先指定的二次结局(风险比0.44；95%可信区间0.22至0.89)。利伐沙班组5982例患者中发生大出血17例(0.28%)，安慰剂组9例(0.15%)(风险比1.88；95%可信区间0.84~4.23)。结论内科患者出院后服用利伐沙班45天，与安慰剂相比，其症状性静脉血栓栓塞症和静脉血栓栓塞性死亡的风险无明显降低。大出血发生率低。
BACKGROUNDPatients who are hospitalized for medical illness remain at risk for venous thromboembolism after discharge, but the role of extended thromboprophylaxis in the treatment of such patients is a subject of controversy.METHODSIn this randomized, double-blind trial, medically ill patients who were at increased risk for venous thromboembolism on the basis of a modified International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) score of 4 or higher (scores range from 0 to 10, with higher scores indicating a higher risk of venous thromboembolism) or a score of 2 or 3 plus a plasma n-dimer level of more than twice the upper limit of the normal range (defined according to local laboratory criteria) were assigned at hospital discharge to either once-daily rivaroxaban at a dose of 10 mg (with the dose adjusted for renal insufficiency) or placebo for 45 days. The primary efficacy outcome was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism. The principal safety outcome was major bleeding.RESULTSOf the 12,024 patients who underwent randomization, 12,019 were included in the intention-to-treat analysis. The primary efficacy outcome occurred in 50 of 6007 patients (0.83%) who were given rivaroxaban and in 66 of 6012 patients (1.10%) who were given placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14). The prespecified secondary outcome of symptomatic nonfatal venous thromboembolism occurred in 0.18% of patients in the rivaroxaban group and 0.42% of patients in the placebo group (hazard ratio, 0.44; 95% CI, 0.22 to 0.89). Major bleeding occurred in 17 of 5982 patients (0.28%) in the rivaroxaban group and in 9 of 5980 patients (0.15%) in the placebo group (hazard ratio, 1.88; 95% CI, 0.84 to 4.23).CONCLUSIONSRivaroxaban, given to medical patients for 45 days after hospital discharge, was not associated with a significantly lower risk of symptomatic venous thromboembolism and death due to venous thromboembolism than placebo. The incidence of major bleeding was low.