Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients
Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients
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DOI：
10.1016/j.jacc.2020.04.071
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发表时间：
2020-06-30
影响因子：
24
通讯作者：
Raskob, Gary E.
中科院分区：
文献类型：
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作者：
Spyropoulos, Alex C.;Ageno, Walter;Raskob, Gary E.
住院的急性病患者有发生致命和重大血栓栓塞事件的危险。是否使用延长时间的初级血栓预防可以预防这些事件是未知的。本研究的目的是评估延长疗程的利伐沙班是否能在不显著增加急性病患者出院后大出血的情况下降低静脉和动脉致死性和重大血栓栓塞事件的风险。方法MARINER（利伐沙班对出院后患者静脉血栓栓塞风险的研究[JNJ-39039039]）研究伴有静脉血栓栓塞（VTE）危险因素的急性内科患者。基线肌酐清除率>= 50 ml/min的疾病患者在出院时以双盲方式随机分配至每日10 mg利伐沙班或安慰剂，持续45天。对意向治疗人群进行探索性疗效分析，包括第45天的所有数据。使用Kaplan-Meier方法计算时间-事件曲线。一个独立的盲法委员会对所有临床事件进行裁决。结果：共有4909名患者被分配到利伐沙班组，4913名患者被分配到安慰剂组。平均年龄67.8岁，55.5%为男性，平均基线肌酐清除率为87.8 ml/min，平均住院时间为6.7天。预先指定的复合疗效终点（症状性静脉血栓栓塞、心肌梗死、非出血性卒中和心血管死亡）在利伐沙班组和安慰剂组中分别有1.28%和1.77%的患者发生（风险比：0.72；95%可信区间：0.52 ~ 1.00;p = 0.049），而在利伐沙班组和安慰剂组中分别有0.27%和0.18%的患者发生大出血（风险比：1.44；95%可信区间：0.62 ~ 3.37;p = 0.398）。结论：延长利伐沙班治疗住院内科患者可使致死性和重大血栓栓塞事件减少28%，而大出血发生率无显著增加。利伐沙班对出院患者静脉血栓栓塞风险的影响[j]； contemporary medicine; 2011；由爱思唯尔代表美国心脏病学会基金会出版。
BACKGROUND Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown.OBJECTIVES The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge.METHODS MARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance >= 50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events.RESULTS In total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398).CONCLUSIONS Extended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564) (C) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.