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阿哌沙班预防癌症患者的静脉血栓栓塞
Apixaban to Prevent Venous Thromboembolism in Patients with Cancer


Marc Carrier ... 心脑血管疾病 肿瘤 • 2019.02.21
相关阅读
• 癌症患者的新发肺栓塞 • 阿哌沙班用于癌症患者的血栓预防

摘要


背景

活动性癌症患者的静脉血栓栓塞风险增加,而静脉血栓栓塞导致高发病率、高死亡率和高医疗费用。Khorana评分(范围为0~6分,较高的评分表示较高的静脉血栓栓塞风险)已被证实可识别静脉血栓栓塞风险较高的癌症患者,且有助于选择可能受益于血栓预防的患者。

 

方法

我们开展了一项随机、安慰剂对照、双盲临床试验,在静脉血栓栓塞中至高危(Khorana评分≥2分)、开始接受化疗的非卧床癌症患者中评估了阿哌沙班(每日2次,每次2.5 mg)预防血栓的疗效和安全性。主要疗效结局为180日随访期间有客观记录的静脉血栓栓塞。主要安全性结局为大出血事件。

 

结果

在被随机分组的574例患者中,563例被纳入改良意向治疗分析。阿哌沙班组288例患者中的12例(4.2%)和安慰剂组275例患者中的28例(11.1%)发生了静脉血栓栓塞(风险比,0.41;95%置信区间[CI],0.26~0.65;P<0.001)。在改良意向治疗分析中,阿哌沙班组10例患者(3.5%)和安慰剂组5例患者(1.8%)发生了大出血(风险比,2.00;95% CI,1.01~3.95;P=0.046)。在治疗期间,阿哌沙班组6例患者(2.1%)和安慰剂组3例患者(1.1%)发生了大出血(风险比,1.89;95% CI,0.39~9.24)。

 

结论

在开始接受化疗的中至高危非卧床癌症患者中,阿哌沙班治疗组的静脉血栓栓塞发生率显著低于安慰剂组。阿哌沙班组的大出血事件发生率高于安慰剂组(由加拿大卫生研究院[Canadian Institutes of Health Research]和百时美施贵宝辉瑞联盟[Bristol-Myers Squibb-Pfizer Alliance]资助;AVERT在ClinicalTrials.gov注册号为NCT02048865)。





作者信息

Marc Carrier, M.D., Karim Abou-Nassar, M.D., Ranjeeta Mallick, Ph.D., Vicky Tagalakis, M.D., Sudeep Shivakumar, M.D., Ariah Schattner, M.D., Philip Kuruvilla, M.D., Danny Hill, M.D., Silvana Spadafora, M.D., Katerine Marquis, M.D., Mateya Trinkaus, M.D., Anna Tomiak, M.D., Agnes Y.Y. Lee, M.D., Peter L. Gross, M.D., Alejandro Lazo-Langner, M.D., Robert El-Maraghi, M.D., Glenwood Goss, M.D., Gregoire Le Gal, M.D., David Stewart, M.D., Timothy Ramsay, Ph.D., Marc Rodger, M.D., Debra Witham, B.Sc.N., and Philip S. Wells, M.D. for the AVERT Investigators*
From the Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa (M.C., R.M., G.G., G.L.G., D.S., T.R., M.R., D.W., P.S.W.), Centre Intégré de Santé et des Services Sociaux de l’Outaouais, Gatineau, QC (K.A.-N.), Jewish General Hospital, Lady Davis Institute for Medical Research, McGill University, Montreal (V.T.), Nova Scotia Health Authority, Halifax (S. Shivakumar), Lakeridge Health, Oshawa, ON (A.S.), William Osler Health Centre, Brampton, ON (P.K.), Sault Area Hospital, Sault Ste. Marie, ON (D.H., S. Spadafora), Hôpital Régional de Rimouski, Rimouski, QC (K.M.), Markham Stouffville Hospital, Markham, ON (M.T.), Kingston General Hospital, Kingston, ON (A.T.), University of British Columbia, British Columbia Cancer Agency, Vancouver (A.Y.Y.L.), Hamilton Health Sciences, Hamilton, ON (P.L.G.), London Health Sciences Centre, London, ON (A.L.-L.), and Royal Victoria Regional Health Centre, Barrie, ON (R.E.-M.) — all in Canada. Address reprint requests to Dr. Wells at the Ottawa Hospital, General Campus, 501 Smyth Rd., Box 206, Ottawa, ON K1H 8L6, Canada, or at pwells@toh.ca. *A complete list of the AVERT Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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