利伐沙班用于医疗疾病住院后的血栓预防。
Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness.
机构信息
From the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Feinstein Institute for Medical Research, and the Department of Medicine, Anticoagulation and Clinical Thrombosis Services, Northwell Health at Lenox Hill Hospital (A.C.S.), and the Cardiovascular Institute, Mount Sinai Medical Center (J.L.H.) - all in New York; the Department of Medicine and Surgery, University of Insubria, Varese, Italy (W.A.); the Stanford Stroke Center, Stanford University Medical Center, Stanford (G.W.A.), and the University of California at Davis, Sacramento (G.A.M.) - both in California; the Department of Medicine, Intermountain Medical Center, and Department of Medicine, University of Utah, Salt Lake City (C.G.E.); Division of Cardiology, University of Colorado School of Medicine, and CPC Clinical Research, Aurora (W.R.H.); Département Hospitalo-Universitaire FIRE (Fibrose Inflammation Remodelage), University Paris Diderot, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); Imperial College, Royal Brompton Hospital, London (P.G.S.); McMaster University and the Thrombosis and Atherosclerosis Research Institute - both in Hamilton, ON, Canada (J.I.W.); Janssen Research and Development, Raritan (E.S., E.S.B.), and the Thrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S., Whippany (T.E.S.) - both in New Jersey; and the College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City (G.E.R.).
出版信息
N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.
BACKGROUND
Patients 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.
METHODS
In 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 d-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.
RESULTS
Of 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).
CONCLUSIONS
Rivaroxaban, 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. (Funded by Janssen Research and Development; MARINER ClinicalTrials.gov number, NCT02111564 .).
背景
患有内科疾病的患者在出院后仍然存在静脉血栓栓塞的风险，但延长血栓预防治疗在这类患者中的作用存在争议。
方法
在这项随机、双盲试验中，根据改良的国际静脉血栓栓塞预防注册（IMPROVE）评分（范围为 0 至 10 分，评分越高表示静脉血栓栓塞风险越高）≥4 分或评分 2 或 3 分且血浆 D-二聚体水平超过正常范围上限的两倍（根据当地实验室标准定义）的内科疾病住院患者，在出院时被分配接受每日一次的利伐沙班 10mg 治疗（根据肾功能不全情况调整剂量）或安慰剂治疗 45 天。主要疗效终点为症状性静脉血栓栓塞或静脉血栓栓塞导致的死亡的复合终点。主要安全性终点为大出血。
结果
在 12024 名接受随机分组的患者中，12019 名患者纳入意向治疗分析。利伐沙班组 6007 例患者中有 50 例（0.83%）和安慰剂组 6012 例患者中有 66 例（1.10%）发生了主要疗效终点事件（风险比，0.76；95%置信区间[CI]，0.52 至 1.09；P=0.14）。利伐沙班组症状性非致死性静脉血栓栓塞的预先指定次要终点发生率为 0.18%，安慰剂组为 0.42%（风险比，0.44；95%CI，0.22 至 0.89）。利伐沙班组 5982 例患者中有 17 例（0.28%）和安慰剂组 5980 例患者中有 9 例（0.15%）发生大出血（风险比，1.88；95%CI，0.84 至 4.23）。
结论
与安慰剂相比，利伐沙班用于内科疾病患者出院后 45 天，并未显著降低症状性静脉血栓栓塞和静脉血栓栓塞导致的死亡风险。大出血发生率较低。（由 Janssen Research and Development 资助；MARINER ClinicalTrials.gov 编号，NCT02111564）。
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