Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study
Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study
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DOI：
10.1093/ehjcvp/pvy021
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发表时间：
2018-10-01
影响因子：
7.1
通讯作者：
Olesen, Jonas Bjerring
中科院分区：
文献类型：
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作者：
Sindet-Pedersen, Caroline;Staerk, Laila;Olesen, Jonas Bjerring
目的：研究利伐沙班或阿哌沙班治疗静脉血栓栓塞（VTE）患者的全因死亡率、复发性静脉血栓栓塞（VTE）和住院出血的风险。方法和结果：使用丹麦全国登记处，确定了2015年1月1日至2017年6月30日期间利伐沙班或阿哌沙班治疗的静脉血栓栓塞患者。标准化的绝对风险是根据结果特异性考克斯回归模型估计的，并对潜在的混杂因素进行了调整。本研究共纳入8187例患者，其中1504例（18%）接受阿哌沙班治疗[50%男性，中位年龄70岁;四分位距（IQR）56-80]，6683例（82%）接受利伐沙班治疗（55%男性，中位年龄67岁; IQR 53-76）。阿哌沙班组的180天全因死亡风险为5.08% [95%置信区间（95% CI）4.08%至6.08%]，利伐沙班组为4.60%（95% CI 4.13%至5.18%）[绝对风险差异：-0.48%（95% CI -1.49%至0.72%）]。阿哌沙班组和利伐沙班组的180天复发性VTE风险分别为2.16%（95% CI 1.49%至2.88%）和2.22%（95% CI 1.89%至2.52%）[绝对风险差异为0.06%（95% CI -0.72%至0.79%）]。住院出血的180天风险为1.73%（95% CI 1.22%至2.35%），阿哌沙班组患者为1.89%（95% CI 1.56%至2.20%）[绝对风险差异：结论在全国范围内接受利伐沙班或阿哌沙班治疗的8187例VTE患者中，全因死亡、复发性VTE或住院出血的风险无显著差异。
Aims To investigate the risk of all-cause mortality, recurrent venous thromboembolism (VTE), and hospitalized bleeding in patients with VTE treated with either rivaroxaban or apixaban.Methods and results Using Danish nationwide registries, patients with VTE treated with rivaroxaban or apixaban in the period from 1 January 2015 to 30 June 2017 were identified. Standardized absolute risks were estimated based on outcome-specific Cox regression models, adjusted for potential confounders. A total of 8187 patients were included in the study, of which 1504 (18%) were treated with apixaban [50% males, median age 70 years; interquartile range (IQR) 56-80] and 6683 (82%) were treated with rivaroxaban (55% males, median age 67 years; IQR 53-76). The 180 days risk of all-cause mortality was 5.08% [95% confidence interval (95% CI) 4.08% to 6.08%)] in the apixaban group and 4.60% (95% CI 4.13% to 5.18%) in the rivaroxaban group [absolute risk difference: -0.48% (95% CI -1.49% to 0.72%)]. The 180 days risk of recurrent VTE was 2.16% (95% CI 1.49% to 2.88%) in the apixaban group and 2.22% (95% CI 1.89% to 2.52%) in the rivaroxaban group [absolute risk difference of 0.06% (95% CI -0.72% to 0.79%)]. The 180 days risk of hospitalized bleeding was 1.73% (95% CI 1.22% to 2.35%) for patients in the apixaban group and 1.89% (95% CI 1.56% to 2.20%) in the rivaroxaban group [absolute risk difference: 0.16% (95% CI -0.59% to 0.81%)].Conclusion In a nationwide cohort of 8187 patients with VTE treated with rivaroxaban or apixaban, there were no significant differences in the risks of all-cause mortality, recurrent VTE, or hospitalized bleeding.