Comparison of Safety and Efficacy Between Dabigatran and Rivaroxaban in Nonvalvular Atrial Fibrillation in Tertiary Level Hospital

Mohammad Hasimul Ahasan, M. Mahmood, D. Adhikary, S. Ahsan, C. M. Ahmed, Md. Abu Salim, Khurshed Ahmed, Md Rasul Amin, Md Fakhrul Islam Khaled, C. Singha, Rashedul Islam, Sanjida Ansari, S. Biswas, Rajon Karna, S. Banerjee
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Abstract

Background: Thromboembolism is a major complication of atrial fibrillation. Vitamin K antagonist is the main oral anticoagulant which was used for prevention of thromboembolism in atrial fibrillation for many years. New oral anticoagulant drugs are emerging as alternatives to warfarin for the prevention of stroke in patients with non-valvular atrial fibrillation. Objective: The aim of the study was to compare safety and efficacy of dabigatran and rivaroxaban for prevention of thromboembolism in tertiary level hospital. Methodology: This Randomized controlled trial study was conducted in the Department of Cardiology in Bangabandhu Sheikh Mujib Medical University, Shahbagh, Dhaka. Patients were divided into two groups, in group A 37 patients were given dabigatran 110 mg twice daily and in group B 37 patients were given rivaroxaban 20 mg daily for 6 months duration. Data was collected according to the pre designed semistructured data collection sheet. Statistical analyses were carried out by using the Statistical Package for Social Sciences (SPSS) version 23.0 for Windows Software. Results: The mean CHADS2- VASC score (Risk of stroke) in rivaroxaban group and in dabigatran group was 3.95±1.37 and 3.74±1.42 respectively. There was no significant difference of CHADS2- VASC score between the two groups. Regarding outcome of 6th month follow up 2(5.4%) patients were lost to follow up in dabigatran group and 3(8.1%) in rivaroxaban group. Comparaing effectiveness and safety study we found that ischemic stroke rate with rivaroxaban group was higher than dabigatran group although statistically not significant. We also found higher bleeding rate in rivaroxaban group than dabigatran group although statistically not significant. Conclusion: Dabigatran is a safe and effective anticoagulant same as rivaroxaban for prevention of thromboembolism in the treatment of non valvular atrial fibrillation. University Heart Journal 2022; 18(1): 10-13
达比加群与利伐沙班治疗三级医院非瓣膜性心房颤动的安全性和有效性比较
背景:血栓栓塞是心房颤动的主要并发症。维生素K拮抗剂是主要的口服抗凝剂,多年来一直用于房颤的血栓栓塞预防。新的口服抗凝药物正在出现,作为华法林的替代品,用于预防非瓣膜性心房颤动患者的卒中。目的:比较达比加群与利伐沙班预防三级医院血栓栓塞的安全性和有效性。方法:本随机对照试验研究在达卡沙赫巴格的Bangabandhu Sheikh Mujib医科大学心内科进行。患者分为两组,A组37例患者给予达比加群110 mg,每日2次;B组37例患者给予利伐沙班20 mg,每日2次,疗程6个月。根据预先设计的半结构化数据收集表收集数据。统计分析采用SPSS 23.0版Windows软件进行。结果:利伐沙班组和达比加群组CHADS2- VASC评分(卒中风险)均值分别为3.95±1.37和3.74±1.42。两组患者CHADS2- VASC评分差异无统计学意义。6个月随访结果方面,达比加群组失访2例(5.4%),利伐沙班组失访3例(8.1%)。比较有效性和安全性研究发现,利伐沙班组缺血性脑卒中发生率高于达比加群组,但无统计学意义。我们还发现利伐沙班组的出血率高于达比加群组,尽管没有统计学意义。结论:达比加群与利伐沙班一样,是一种安全有效的抗凝剂,可预防非瓣膜性房颤的血栓栓塞。大学心脏杂志2022;18 (1): 10 - 13
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