Bundhun Pravesh Kumar, Soogund Mohammad Zafooruddin Sani, Teeluck Abhishek Rishikesh, Pursun Manish, Bhurtu Akash, Huang Wei-Qiang
Institute of Cardiovascular Diseases, the First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530027, People's Republic of China.
Guangxi Medical University, Nanning, Guangxi, 530027, People's Republic of China.
BMC Cardiovasc Disord. 2017 Jan 6;17(1):15. doi: 10.1186/s12872-016-0449-2.
Warfarin is commonly used as a secondary prevention of stroke in patients with atrial fibrillation (AF). However, limitations have been observed even with the use of this medication. Recently, several newer direct oral anticoagulants (DOACs) have been approved for use by the food and drug administrations. Unfortunately, these newer drugs have seldom been compared directly with each other. Therefore, this study aimed to compare the bleeding events associated with rivaroxaban and dabigatran in patients treated for non-valvular AF.
EMBASE, Medline (National Library of Medicine) and the Cochrane Central Registry of Controlled Trials were searched for studies comparing rivaroxaban with dabigatran using the terms 'rivaroxaban, dabigatran and atrial fibrillation'. Primary endpoints were: any bleeding outcomes, intracranial bleeding and gastro-intestinal (GI) bleeding. Secondary outcomes included stroke/systemic embolism (SE)/transient ischemic attack (TIA), venous thromboembolism and mortality. Odds ratios (OR) with 95% confidence intervals (CIs) were calculated. The pooled analyses were carried out with RevMan 5.3 software. All the authors had full access to the data and approved the manuscript as written.
A total number of 4895 patients were included. This analysis showed that rivaroxaban was not associated with a significantly higher bleeding event when compared to dabigatran (OR: 1.28, 95% CI: 0.95-1.72; P = 0.11). GI bleeding was similarly manifested between these two DOACs (OR: 0.98, 95% CI: 0.43-2.25; P = 0.97). Even if intracranial bleeding was higher with the use of rivaroxaban, (OR: 2.18, 95% CI: 0.51-9.25; P = 0.29), the result was not statistically significant. Moreover, stroke/SE/TIA and venous thromboembolism were also not significantly different (OR: 0.81, 95% CI: 0.53-1.23; P = 0.32) and (OR: 2.06, 95% CI: 0.73-5.82; P = 0.17) respectively. However, even if mortality favored dabigatran (OR: 1.42, 95% CI: 0.99-2.06; P = 0.06), this result only approached statistical significance.
Head to head comparison showed that rivaroxaban was not associated with significantly higher bleeding events compared to dabigatran. Intracranial bleeding, GI bleeding, stroke/SE/TIA, venous thromboembolism and mortality were also not significantly different between these two DOACs. However, due to the limited number of patients analyzed, and which were mainly obtained from observational studies, this hypothesis might only be confirmed in future randomized trials. Furthermore, the CHADS-VASC and HAS-BLED score which might play an important role in predicting bleeding risks should also not be ignored.
华法林常用于心房颤动（AF）患者的卒中二级预防。然而，即便使用这种药物也存在局限性。最近，几种新型直接口服抗凝剂（DOACs）已获食品药品管理部门批准使用。遗憾的是，这些新药之间很少进行直接比较。因此，本研究旨在比较利伐沙班和达比加群在非瓣膜性AF患者治疗中相关的出血事件。
通过检索EMBASE、Medline（美国国立医学图书馆）和Cochrane对照试验中央注册库，使用“利伐沙班、达比加群和心房颤动”等术语查找比较利伐沙班与达比加群的研究。主要终点为：任何出血结局、颅内出血和胃肠道（GI）出血。次要结局包括卒中/全身性栓塞（SE）/短暂性脑缺血发作（TIA）、静脉血栓栓塞和死亡率。计算比值比（OR）及95%置信区间（CI）。采用RevMan 5.3软件进行汇总分析。所有作者均可全面获取数据并批准了最终稿件。
共纳入4895例患者。该分析表明，与达比加群相比，利伐沙班并未伴有显著更高的出血事件（OR：1.28，95%CI：0.95 - 1.72；P = 0.11）。这两种DOACs的GI出血表现相似（OR：0.98，95%CI：0.43 - 2.25；P = 0.97）。即便使用利伐沙班时颅内出血更高（OR：2.18，95%CI：0.51 - 9.25；P = 0.29），结果也无统计学意义。此外，卒中/SE/TIA和静脉血栓栓塞也无显著差异（OR分别为0.81，95%CI：0.53 - 1.23；P = 0.32）和（OR：2.06，95%CI：0.73 - 5.82；P = 0.17）。然而，即便死亡率有利于达比加群（OR：1.42，95%CI：0.99 - 2.06；P = 0.06），该结果仅接近统计学意义。
直接对比表明，与达比加群相比，利伐沙班并未伴有显著更高的出血事件。这两种DOACs在颅内出血、GI出血、卒中/SE/TIA、静脉血栓栓塞和死亡率方面也无显著差异。然而，由于分析的患者数量有限，且主要来自观察性研究，这一假设可能仅在未来的随机试验中得到证实。此外，在预测出血风险中可能起重要作用的CHADS - VASC和HAS - BLED评分也不应被忽视。
