Spyropoulos Alex C, Lipardi Concetta, Xu Jianfeng, Peluso Colleen, Spiro Theodore E, De Sanctis Yoriko, Barnathan Elliot S, Raskob Gary E
The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Feinstein Institute for Medical Research and Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, New York, New York, United States.
Janssen Research & Development, LLC, Raritan, New Jersey, United States.
TH Open. 2020 Mar 13;4(1):e59-e65. doi: 10.1055/s-0040-1705137. eCollection 2020 Jan.
An individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51-0.91, = 0.008) and in the lower-risk group (RR: 0.69, 95% CI: 0.40 -1.20, = 0.187). The modified IMPROVE VTE score with an elevated D-dimer identified a nearly threefold higher VTE risk subpopulation of patients where a significant benefit exists for ET using rivaroxaban.
需要一种个体化方法来识别静脉血栓栓塞(VTE)风险增加且出血风险低的急性病患者,以优化延长血栓预防(ET)的获益和风险。国际静脉血栓栓塞医学预防登记处(IMPROVE)VTE风险评分已在住院的内科患者中进行了广泛的外部验证,并且在ET的MARINER试验中使用了一种改良模型,该模型还纳入了升高的D-二聚体。MAGELLAN研究证明了利伐沙班的疗效,但存在出血过多的问题。这项回顾性分析调查了具有升高D-二聚体的改良IMPROVE VTE模型是否能够从MAGELLAN研究的一个亚组患者中识别出ET的高VTE风险亚组,该亚组先前被确定为出血风险较低。我们将使用截断分数为4或更高或2和3且D-二聚体升高(>正常上限的2倍)的改良IMPROVE VTE评分应用于MAGELLAN亚组。总体而言,56%的患者符合高风险标准。在安慰剂组中,第35天高风险组的总VTE事件发生率为7.94%,低风险组患者为2.83%。在高风险组中观察到利伐沙班使VTE减少(相对风险[RR]:0.68,95%置信区间[CI]:0.51 - 0.91,P = 0.008),在低风险组中也有减少(RR:0.69,95% CI:0.40 - 1.20,P = 0.187)。具有升高D-二聚体的改良IMPROVE VTE评分识别出VTE风险几乎高三倍的患者亚组,在该亚组中使用利伐沙班进行ET有显著获益。