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

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Published Dec 27, 2025
https://doi.org/10.62438/tunismed.v103i10.6102
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Vol. 103 No. 10 (2025): Tunis Med Oct 2025

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Eman Youssef
Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
Mohanad Daher
Faculty of Medicine, Damascus University, Damascus, Syria
Abanoub Milad
Faculty of Medicine, Cairo University, Cairo, Egypt
Aliaa Gamal
Clinical Pharmacy Department, Faculty of Deraya University, Minia, Egypt
Rafeek Elmezayen
Faculty of Medicine, Kafr El-Sheikh University, Kafr El-Sheikh, Egypt

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). We conducted this meta-analysis to assess the effectiveness and safety of dabigatran compared to warfarin in AF patients with VHD and NVHD.


Methods and results: Online databases were searched for eligible studies. Ten RCTs (22981 patients) were included. In NVHD subgroup, dabigatran 150 mg showed no statistically significantly difference in stroke (S) and systemic embolism (SE) (risk difference (RD) -0.01,95% confidence interval(CI):-0.01,0.0), and death (RD -0.00,95% CI -0.01,0.00) except for intracranial hemorrhage (ICH) (RD -0.01,95% CI -0.01,-0.01), and major bleeding (RD -0.02,95% CI -0.04,-0.00), similarly ,110 mg showed a low risk of ICH (RD -0.01,95% CI -0.01,-0.01), and no significant differences in S/SE and death compared to warfarin. In VHD subgroup, dabigatran showed no significant differences in S/SE (RD 0.02,95% CI -0.03,0.07), major bleeding (RD 0.01,95% CI -0.02,0.04), and death (RD -0.01,95% CI -0.04,0.01) compared to warfarin. In the catheter ablation subgroup, dabigatran reduced only groin hematoma (RD -0.02,95% CI -0.03,-0.00).


Conclusion: Dabigatran 150 mg and 110 mg was superior to warfarin in AF patients with NVHD in reducing bleeding particularly ICH; However, no significant difference in reducing S/SE, and mortality. In catheter ablation, dabigatran reduced only groin hematoma. In the VHD subgroup, dabigatran did not show superiority or inferiority to warfarin; further studies are needed. “Non-valvular AF” should be replaced with “type II VHD” to distinguish it from other valvular heart diseases.

Keywords:

Catheter ablation, Dabigatran, Non-valvular atrial fibrillation, Valvular atrial fibrillation, Warfarin

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