Is dabigatran a good alternative to warfarin in patients with atrial fibrillation accompanied by valvular and nonvalvular heart diseases? A systematic review and meta-analysis

Abstract

Abstract Background There is ongoing discussion regarding the terminology used when atrial fibrillation (AF) is present alongside either valvular heart disease (VHD) or non-valvular heart disease (NVHD). Warfarin has been used for decades for stroke (S) and systemic embolism (SE) prophylaxis in atrial fibrillation (AF) patients. However, due to its drug and food interactions, pharmacogenetic approach via VKORC1, narrow therapeutic window, frequent monitoring, and high risk of intracranial hemorrhage (ICH), it is not preferred as a first-line anticoagulant for AF patients. Is it time to retire warfarin and replace it with dabigatran? Aim and objectives We conducted this meta-analysis to assess the effectiveness and safety of dabigatran compared to warfarin and find out how likely it could be used instead of warfarin in AF patients with VHD and NVHD. Methods PubMed, SCOPUS, Web of Science, and Cochrane CENTRAL were searched online from inception till June 2023, and eligible randomized controlled trials (RCTs) were selected. The outcomes were analyzed and calculated using the risk ratio (RR), and its confidence interval (CI) using STATA software. The Cochrane Risk of Bias 2.0 tool (ROB2) was used to assess the included studies. Results In the NVHD subgroup, dabigatran 150 mg showed a significantly low risk of S and SE (RR 0.74, 95% CI: [0.62,0.88]), ICH (RR 0.38, 95% CI: [0.26,0.56]), death (RR 0.85, 95% CI: [0.74,0.99]), and high risk of gastrointestinal bleeding (GIB) (RR 1.47, 95% CI: [1.17,1.85]) compared to Warfarin. Dabigatran 110 mg showed a low risk of ICH (RR 0.31, 95% CI: [0.21,0.47]), and no significant differences in S/SE (RR 1.02, 95% CI: [0.87,1.19]) and death (RR 0.94, 95% CI: [0.82,1.09]) compared to warfarin. In the VHD subgroup, dabigatran showed no significant differences in S/SE (RR 2.57, 95% CI: [0.57,11.56]), major bleeding (RR 1.14, 95% CI: [0.35,3.68]), and death (RR 0.35, 95% CI: [0.07,1.81]) compared to warfarin. In the catheter ablation subgroup, dabigatran showed a significant reduction only in groin hematoma (RR 0.19, 95% CI: [0.05,0.73]), compared to warfarin. Conclusion Dabigatran 150 mg was superior to warfarin in AF patients with NVHD; except with GIB; otherwise, Dabigatran 110 mg was superior only to warfarin in reducing ICH. In catheter ablation, dabigatran only reduced the groin hematoma. In AF patients with VHD, dabigatran did not show either superiority or inferiority to warfarin, further studies are needed. “Non-valvular AF” term is outdated and should be replaced with “type II VHD” to differentiate it from other valvular heart diseases that are accompanied by AF.