直接口服抗凝剂在生物瓣膜中的安全性和有效性：一项系统评价和荟萃分析。
Safety and efficacy of direct oral anticoagulants in bioprosthetic valves: A systematic review and meta-analysis.
作者信息
Bakr Lubna, Elsayed Ahmed, Saleh Omar, Abdalraouf Mostafa, Ng Ghulam André, Ibrahim Mokhtar
机构信息
The Royal College of Surgeons of England, London, United Kingdom.
Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.
出版信息
Front Cardiovasc Med. 2023 Feb 27;10:1099591. doi: 10.3389/fcvm.2023.1099591. eCollection 2023.
BACKGROUND
Direct oral anticoagulants are efficient alternatives to vitamin K antagonists. There is little evidence regarding their use in patients who underwent bioprosthetic valve replacement whether surgically or through a transcatheter approach and have another indication of anticoagulation. Trials have compared different members of the DOACs family to VKAs and showed that they were at least non-inferior to VKAs with regard to safety and efficacy. However, this is still controversial. Our meta-analysis aims at providing a clearer view of their future use in this subgroup of patients.
METHODS
PubMed and Cochrane were searched for randomised clinical trials and observational studies. Bleeding, stroke, and all-cause mortality were the outcomes of interest.
RESULTS
Ten papers with a total of 4,088 patients were included. Our meta-analysis revealed no significant differences between the incidence of bleeding between DOACs and warfarin (16% vs. 17%, OR = 0.94, 95% CI [0.56-1.57], = 0.81, = 81%). No statistical difference was found in stroke between both groups (2.5% vs. 3.3%, OR = 0.75, 95% CI [0.41-1.38], = 0.36, = 35%). All-cause mortality was not statistically significant between both groups (9.2% vs. 13.7%, OR = 0.85, 95% CI [0.68-1.07], = 0.16, = 56%). Interestingly, subgroup analysis of randomised controlled trials and prospective studies favoured DOACs with lower risks of both bleeding and stroke.
CONCLUSION
Direct oral anticoagulants appear to be at least as safe and effective as VKAs in patients with bioprosthetic valves and another indication of anticoagulation. There could be potential benefit from the use of DOACs; however, further evidence is required.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021222146, identifier CRD42021222146.
背景
直接口服抗凝剂是维生素K拮抗剂的有效替代药物。对于接受生物瓣膜置换术（无论是通过手术还是经导管途径）且有其他抗凝指征的患者，关于使用直接口服抗凝剂的证据很少。试验比较了直接口服抗凝剂（DOACs）家族的不同成员与维生素K拮抗剂（VKAs），结果显示在安全性和有效性方面，它们至少不劣于维生素K拮抗剂。然而，这一点仍存在争议。我们的荟萃分析旨在更清楚地了解它们在这一亚组患者中的未来应用情况。
方法
检索PubMed和Cochrane数据库以查找随机临床试验和观察性研究。出血、中风和全因死亡率是感兴趣的结局指标。
结果
纳入了10篇论文，共4088例患者。我们的荟萃分析显示，直接口服抗凝剂与华法林的出血发生率无显著差异（16%对17%，OR = 0.94，95% CI [0.56 - 1.57]，P = 0.81，I² = 81%）。两组中风发生率无统计学差异（2.5%对3.3%，OR = 0.75，95% CI [0.41 - 1.38]，P = 0.36，I² = 35%）。两组全因死亡率无统计学差异（9.2%对13.7%，OR = 0.85，95% CI [0.68 - 1.07]，P = 0.16，I² = 56%）。有趣的是，随机对照试验和前瞻性研究的亚组分析显示直接口服抗凝剂在出血和中风风险方面较低。
结论
对于有生物瓣膜且有其他抗凝指征的患者，直接口服抗凝剂似乎至少与维生素K拮抗剂一样安全有效。使用直接口服抗凝剂可能有潜在益处；然而，还需要进一步的证据。
系统评价注册
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021222146，标识符CRD42021222146 。
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