Effectiveness and Safety of Oral Anticoagulants in the Treatment of Acute Venous Thromboembolism: A Nationwide Comparative Cohort Study in France.
Effectiveness and Safety of Oral Anticoagulants in the Treatment of Acute Venous Thromboembolism: A Nationwide Comparative Cohort Study in France.
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DOI：
10.1055/a-1731-3922
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发表时间：
2022-08
影响因子：
6.7
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中科院分区：
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来自临床试验的 数据表明，直接口服抗凝剂(DOAC)在治疗静脉血栓栓塞症(包括深静脉血栓形成和肺血栓(PE))方面比传统疗法(低分子肝素和维生素K拮抗剂)更安全、更安全。这项研究在现实环境中比较了DOAC和传统疗法的有效性和安全性。方法 这项观察性研究使用了法国国家索赔数据，这些患者在2013年至2018年期间因静脉血栓栓塞术(阿匹沙班或利伐沙班)或VKA而住院和治疗，被诊断为静脉血栓栓塞症(大多数为PE)。排除活动性癌症患者。在每次DOAC-VKA比较的倾向评分匹配后，在6个月时比较出血、复发VTE和全因死亡率的风险。用COX比例风险回归估计调整后的终点风险比。结果 共纳入58,137例患者，其中VKA 10,775例，阿匹沙班10,440例，利伐沙班36,922例。倾向得分匹配的队列大小阿匹沙班为7503人，利伐沙班为9179人。对于需要住院的出血(0.43[0.32-0.59])、全因死亡(0.61[0.51-0.74])和首次复发的VTE(0.67[0.52-0.85])，APIXABAN组的风险比(95%可信区间)显著低于VKA组。在全因死亡方面，利伐沙班的风险比显著低于VKA(0.63[0.53-0.74])，但对于需要住院的出血(0.86[0.69-1.07])或首次复发的VTE(0.91[0.74-1.13])，利伐沙班的风险比并不低。结论 阿匹卡班的安全性和有效性均优于VKA。两种DOAC的全因死亡率均低于VKA。我们的结果支持使用DOAC而不是VKA治疗VTE的建议。
Introduction Data from clinical trials indicate that direct oral anticoagulants (DOACs) are noninferior and safer than conventional therapy (low-molecular-weight heparin followed by a vitamin K antagonist [VKA]) for treating venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism (PE). This study compared the effectiveness and safety of DOACs and conventional therapy in a real-world setting. Methods This observational study used French national claims data of adult, treatment-naïve patients diagnosed with VTE (majority PE) who were hospitalized and treated for VTE with a DOAC (apixaban or rivaroxaban) or VKAs during 2013 to 2018. Patients with active cancer were excluded. After propensity score matching for each DOAC-VKA comparison, risks of bleeding, recurrent VTE, and all-cause mortality were compared at 6 months. Cox proportional hazards regression was used to estimate adjusted hazard ratios of the endpoints. Results A total of 58,137 patients were included (10,775 VKAs, 10,440 apixaban, 36,922 rivaroxaban). Propensity score-matched cohort sizes were 7,503 for apixaban and 9,179 for rivaroxaban. The hazard ratio (95% confidence interval) was significantly lower for apixaban than VKAs for bleeding requiring hospitalization (0.43 [0.32–0.59]), all-cause death (0.61 [0.51–0.74]), and first recurrent VTE (0.67 [0.52–0.85]). The hazard ratio was also significantly lower for rivaroxaban than VKAs for all-cause death (0.63 [0.53–0.74]) but not for bleeding requiring hospitalization (0.86 [0.69–1.07]) or first recurrent VTE (0.91 [0.74–1.13]). Conclusion Apixaban was associated with superior safety and effectiveness than VKAs. All-cause mortality was lower in both DOACs than VKAs. Our results support recommendations to use DOACs over VKAs for the treatment of VTE.
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