Are NOACs as safe and efficient as VKA regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?
Are NOACs as safe and efficient as VKA regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?
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在手术后3个月内，NOAC在手术生物植物治疗和心房颤动的患者中是否对血栓栓塞预防和大量出血的NOAC像VKA一样有效？
DOI：
10.1093/icvts/ivab363
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发表时间：
2022-05-02
影响因子：
--
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中科院分区：
文献类型：
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根据结构化方案编写心脏手术中的最佳证据主题。讨论的问题是：“NOAC是否与维生素K拮抗剂一样安全有效，用于手术后3个月内植入手术生物假体和房颤患者的血栓栓塞预防和大出血？”使用报告的检索共发现超过324篇论文，其中6篇代表了回答临床问题的最佳证据。这些论文的作者、期刊、发表日期和国家、研究的患者组、研究类型、相关结局和结果均列表显示。RIVER和ENAVLE试验显示，与维生素K拮抗剂相比，利伐沙班（关于12个月时无死亡、重大心血管事件或大出血复合事件的平均时间）和依度沙班（死亡、临床血栓栓塞事件或无症状心内血栓形成和大出血复合事件）具有非劣效性。这些研究包括首次手术后3个月内的少量患者，并且该特定患者亚组的总体统计学把握度较低。来自低证据研究的数据与上述结果一致。现有证据表明，在植入外科生物瓣膜和房颤的患者中，非维生素K拮抗剂抗凝剂在生物瓣膜植入后3个月内的血栓栓塞预防和出血事件发生率方面与维生素K拮抗剂一样安全有效。然而，这些证据来自数量有限的研究，具有重要的方法局限性。将非维生素K拮抗剂抗凝剂推荐扩大到术后早期需要更多的验证性研究。根据结构化协议构造最佳证据主题。
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: ‘Are NOACs as safe and efficient as vitamin K antagonist regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?’ Altogether more than 324 papers were found using the reported search, of which 6 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The RIVER and ENAVLE trials showed non-inferiority of rivaroxaban (regarding mean time free from composite of death, major cardiovascular events or major bleeding at 12 months) and edoxaban (composite of death, clinical thromboembolic events or asymptomatic intracardiac thrombosis; and major bleeding) when compared with vitamin K antagonist. These studies include a low number of patients within 3 months of index surgery and overall low statistical power regarding this particular subgroup of patients. Data derived from lower evidence studies are compatible with the aforementioned findings. The available evidence suggests that non-vitamin K antagonist anticoagulants are as safe and as efficient as vitamin K antagonist regarding thromboembolic prophylaxis and bleeding event rates in patients with surgical bioprosthesis and atrial fibrillation within 3 months of bioprosthesis implantation. However, this evidence is derived from a limited number of studies with important methodological limitations. Expanding non-vitamin K antagonist anticoagulant recommendation to the early postoperative period warrants more confirmatory research. A best evidence topic was constructed according to a structured protocol.
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影响因子：
3.2
作者：
Pasciolla, Stacy;Zizza, Laura Falconieri;Wright, Kesha
通讯作者：
Wright, Kesha
DOI：
10.1016/s1569-9293(03)00191-9
发表时间：
2003-12-01
影响因子：
--
作者：
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通讯作者：
Mackway-Jones, Kevin
影响因子：
158.5
作者：
Guimaraes, Helio P.;Lopes, Renato D.;Berwanger, Otavio
通讯作者：
Berwanger, Otavio
影响因子：
2.7
作者：
Guimaraes, Patricia O.;Pokorney, Sean D.;Granger, Christopher B.
通讯作者：
Granger, Christopher B.
影响因子：
4.6
作者：
Nauffal, Victor;Trinquart, Ludovic;Ellinor, Patrick T.
通讯作者：
Ellinor, Patrick T.