体重对非瓣膜性心房颤动患者直接口服抗凝剂疗效和安全性的影响：一项荟萃分析。
Impact of weight on the efficacy and safety of direct-acting oral anticoagulants in patients with non-valvular atrial fibrillation: a meta-analysis.
作者信息
Malik Aaqib H, Yandrapalli Srikanth, Shetty Suchith, Aronow Wilbert S, Jain Diwakar, Frishman William H, Cooper Howard A, Panza Julio A
机构信息
Department of Medicine, Westchester Medical Center, New York Medical College, 100 Woods Road, Valhalla, NY 10595, USA.
Department of Cardiology, Westchester Medical Center, New York Medical College, Valhalla, NY, USA.
出版信息
Europace. 2020 Mar 1;22(3):361-367. doi: 10.1093/europace/euz361.
AIMS
This study sought to determine the impact of weight and body mass index (BMI) on the safety and efficacy of direct-acting oral anticoagulants (DOACs) compared with warfarin in patients with non-valvular atrial fibrillation.
METHODS AND RESULTS
A systematic literature search was employed in PubMed, Embase, and Cochrane clinical trials with no language or date restrictions. Randomized trials or their substudies were assessed for relevant outcome data for efficacy that included stroke or systemic embolization (SSE), and safety including major bleeding and all-cause mortality. Binary outcome data and odds ratios from the relevant articles were used to calculate the pooled relative risk. For SSE, the data from the four Phase III trials showed that DOACs are better or similarly effective with low BMI 0.73 (0.56-0.97), normal BMI 0.72 (0.58-0.91), overweight 0.87 (0.76-0.99), and obese 0.87 (0.76-1.00). The risk of major bleeding was also better or similar with DOACs in all BMI subgroups with low BMI 0.62 (0.37-1.05), normal BMI 0.72 (0.58-0.90), overweight 0.83 (0.71-0.96), and obese 0.91 (0.81-1.03). There was no impact on mortality in all the subgroups. In a meta-regression analysis, the effect size advantage of DOACs compared with warfarin in terms of safety and efficacy gradually attenuated with increasing weight.
CONCLUSION
Our findings suggest that a weight-based dosage adjustment may be necessary to achieve optimal benefits of DOACs for thromboembolic prevention in these patients with non-valvular atrial fibrillation. Further dedicated trials are needed to confirm these findings. PROSPERO 2019 CRD42019140693. Available from: https://www.crd.york.ac.uk/prospero/display_record.php? ID=CRD42019140693.
目的
本研究旨在确定与华法林相比，体重和体重指数（BMI）对非瓣膜性心房颤动患者使用直接口服抗凝剂（DOACs）的安全性和有效性的影响。
方法与结果
在PubMed、Embase和Cochrane临床试验中进行了无语言或日期限制的系统文献检索。对随机试验或其亚研究评估相关结局数据，包括疗效方面的卒中或全身性栓塞（SSE），以及安全性方面的大出血和全因死亡率。使用相关文章中的二元结局数据和比值比来计算合并相对风险。对于SSE，四项III期试验的数据显示，DOACs在低BMI（0.73，0.56 - 0.97）、正常BMI（0.72，0.58 - 0.91）、超重（0.87，0.76 - 0.99）和肥胖（0.87，0.76 - 1.00）患者中疗效更好或相似。在所有BMI亚组中，DOACs的大出血风险也更好或相似，低BMI为0.62（0.37 - 1.05），正常BMI为0.72（0.58 - 0.90），超重为0.83（0.71 - 0.96），肥胖为0.91（0.81 - 1.03）。对所有亚组的死亡率均无影响。在一项meta回归分析中，与华法林相比，DOACs在安全性和有效性方面的效应大小优势随着体重增加而逐渐减弱。
结论
我们的研究结果表明，对于这些非瓣膜性心房颤动患者，可能需要进行基于体重的剂量调整，以实现DOACs在预防血栓栓塞方面的最佳效益。需要进一步的专门试验来证实这些发现。PROSPERO 2019 CRD42019140693。可从：https://www.crd.york.ac.uk/prospero/display_record.php? ID=CRD42019140693获取。
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