Division of Cardiology, East Tennessee State University, Johnson City, TN.
Am J Ther. 2021 Aug 18;29(1):e56-e63. doi: 10.1097/MJT.0000000000001391.
Current guidelines give class I recommendations for uninterrupted use of dabigatran rivaroxaban as an alternative to vitamin K antagonist (VKA) in patients of atrial fibrillation (AF) who are undergoing catheter ablation. The recent randomized controlled trials have shown similar efficacy of novel oral anticoagulants when compared to VKA in these patients. We sought to perform a meta-analysis with a focus on subgroup analysis of novel oral anticoagulants.
We searched PubMed, Clinical trials registry and the Cochrane Center Register of Controlled Trials were searched through August 2020. Six RCTs studies (n = 2260) comparing the use of NOACs versus VKA in patients with AF undergoing catheter ablation were included. The odds ratio (OR) with 95% confidence interval was computed and P < 0.05 was considered as a level of significance. Major adverse cardiac events (MACE) were considered as a primary endpoint.
Our results showed a significant difference in MACE between NOACs and VKA [OR 0.57 (0.37-0.88); P = 0.01] and in major bleeding events [OR 0.55 (0.35-0.86); P = 0.009], which is mainly derived from the use of dabigatran. No significant difference in MACE or major bleeding events was found on the subgroup analysis of rivaroxaban and apixaban over VKA therapy.
Uninterrupted use of NOACs is safe and effective alternative for the prevention of cerebral thromboembolism and reducing the risk of major bleeding in patients undergoing catheter ablation of AF. However, the individual subgroup analysis showed that only dabigatran is superior to VKA in terms of reducing MACE through a reduction in major bleeding. The rivaroxaban, apixaban and edoxaban are non-inferior to VKA therapy based on these results. Further studies are needed to generalize these recommendations in morbidly obese patients.
目前的指南建议，对于正在接受导管消融的房颤（AF）患者，华法林（VKA）可作为替代物，继续使用达比加群或利伐沙班，这属于 I 类推荐。最近的随机对照试验表明，在这些患者中，新型口服抗凝剂（NOACs）与 VKA 的疗效相当。我们旨在进行一项荟萃分析，重点关注新型口服抗凝剂的亚组分析。
我们检索了 PubMed、临床试验注册处和 Cochrane 中心对照试验登记处，检索截至 2020 年 8 月。共纳入 6 项比较导管消融治疗的 AF 患者中使用 NOACs 与 VKA 的 RCT 研究（n = 2260）。计算比值比（OR）及其 95%置信区间，P < 0.05 被认为是统计学显著性水平。主要不良心脏事件（MACE）被认为是主要终点。
我们的结果显示，NOACs 与 VKA 相比，MACE 差异有统计学意义[OR 0.57（0.37-0.88）；P = 0.01]，大出血事件[OR 0.55（0.35-0.86）；P = 0.009]差异也有统计学意义，这主要归因于达比加群的使用。亚组分析发现，利伐沙班和阿哌沙班与 VKA 治疗相比，MACE 或大出血事件无显著差异。
在接受 AF 导管消融的患者中，NOACs 的不间断使用是安全有效的，可预防脑血栓栓塞，并降低大出血风险。然而，个体亚组分析显示，只有达比加群通过减少大出血来降低 MACE，优于 VKA。基于这些结果，利伐沙班、阿哌沙班和依度沙班与 VKA 治疗相比，非劣效性。需要进一步的研究来推广这些在病态肥胖患者中的建议。
