Circulation Journal ( IF 3.1 ) Pub Date : 2020-10-23 , DOI: 10.1253/circj.cj-20-0223 Yuji Nishimoto 1 , Yugo Yamashita 2 , Kitae Kim 3 , Takeshi Morimoto 4 , Syunsuke Saga 1 , Hidewo Amano 5 , Toru Takase 6 , Seiichi Hiramori 7 , Maki Oi 8 , Masaharu Akao 9 , Yohei Kobayashi 10 , Mamoru Toyofuku 11 , Toshiaki Izumi 12 , Tomohisa Tada 13 , Po-Min Chen 14 , Koichiro Murata 15 , Yoshiaki Tsuyuki 16 , Tomoki Sasa 17 , Jiro Sakamoto 18 , Minako Kinoshita 19 , Kiyonori Togi 20 , Hiroshi Mabuchi 21 , Kensuke Takabayashi 22 , Yusuke Yoshikawa 2 , Hiroki Shiomi 2 , Takao Kato 2 , Takeru Makiyama 2 , Koh Ono 2 , Yukihito Sato 1 , Takeshi Kimura 2 ,
Background:Patients with cancer-associated venous thromboembolism (VTE) are at high risk for recurrent VTE and are recommended to receive prolonged anticoagulation therapy if they are at a low risk for bleeding. However, there are no established risk factors for bleeding during anticoagulation therapy.
Methods and Results:The COMMAND VTE Registry is a multicenter retrospective registry enrolling 3,027 consecutive patients with acute symptomatic VTE among 29 Japanese centers. The present study population consisted of 592 cancer-associated VTE patients with anticoagulation therapy. We constructed a multivariable Cox proportional hazard model to estimate the hazard ratio (HR) and 95% confidence interval (CI) of the potential risk factors for major bleeding. During a median follow-up period of 199 days, major bleeding occurred in 72 patients. The cumulative incidence of major bleeding was 5.8% at 3 months, 13.8% at 1 year, 17.5% at 2 years, and 28.1% at 5 years. The most frequent major bleeding site was gastrointestinal tract (47%). Terminal cancer (adjusted HR, 4.17; 95% CI, 2.22–7.85, P<0.001), chronic kidney disease (adjusted HR, 1.89; 95% CI 1.06–3.37, P=0.031), and gastrointestinal cancer (adjusted HR, 1.78; 95% CI, 1.04–3.04, P=0.037) were independently associated with an increased risk of major bleeding.
Conclusions:Major bleeding events were common during anticoagulation therapy in real-world cancer-associated VTE patients. Terminal cancer, chronic kidney disease, and gastrointestinal cancer were the independent risk factors for major bleeding.
中文翻译：
癌症相关静脉血栓栓塞抗凝治疗期间大出血的危险因素 ― 来自 COMMAND VTE 登记处 ―
背景：癌症相关静脉血栓栓塞 (VTE) 患者发生 VTE 复发的风险较高，如果出血风险较低，建议接受延长的抗凝治疗。然而，在抗凝治疗期间没有确定的出血危险因素。
方法和结果：COMMAND VTE 登记处是一个多中心回顾性登记处，在日本 29 个中心招募了 3,027 名连续的急性症状性 VTE 患者。本研究人群由 592 名接受抗凝治疗的癌症相关 VTE 患者组成。我们构建了一个多变量 Cox 比例风险模型来估计大出血潜在危险因素的风险比 (HR) 和 95% 置信区间 (CI)。在中位随访 199 天期间，72 名患者发生大出血。大出血的累积发生率在 3 个月时为 5.8%，在 1 年时为 13.8%，在 2 年时为 17.5%，在 5 年时为 28.1%。最常见的大出血部位是胃肠道（47%）。晚期癌症（调整后的 HR，4.17；95% CI，2.22-7.85，P<0.001），慢性肾病（调整后的 HR，1.89；95% CI，1.06-3.37，P=0.031），
结论：在现实世界癌症相关 VTE 患者的抗凝治疗期间，大出血事件很常见。晚期癌症、慢性肾病和胃肠道癌是大出血的独立危险因素。
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