Abstract
Abstract Background Diabetes Mellitus (DM) is an independent risk factor for stroke and atrial fibrillation (AF). Therefore, the risk/benefit profile of the direct oral anticoagulants (DOAC) is of clinical interest. Purpose To compare efficacy and safety outcomes of DOAC for nonvalvular AF in patients with DM versus without DM. Methods We systematically searched PubMed, Embase and Cochrane databases, in January 2020, for interventional studies comparing DOAC efficacy and safety in patients with AF and diabetes versus without diabetes. Results Four randomized clinical trials were included, providing a total of 63987 patients, 18860 with DM and 45127 without DM. In terms of efficacy, our meta-analysis revealed a similar rate of stroke/systemic embolism (pooled OR 1.02 [0.79, 1.31], P=0.87, I2=83%), stroke (pooled OR 1.98 [0.68, 1.40], P=0.90, I2=90%) and all-cause mortality (pooled OR 1.18 [0.97, 1.43], P=0.10, I2=87%), albeit with a significant heterogeneity. However, in direct factor Xa inhibitors sub analysis, diabetic patients had a lower trend of systemic embolism/stroke (pooled OR 0.90 [0.79, 1.02], P=0.09, I2=18%), significantly lower stroke rate (pooled OR 0.82 [0.73, 0.93], P<0.01, I2=0%), but a higher all-cause mortality (pooled OR 1.08 [1.00, 1.16], P<0.01, I2=0%). In terms of safety, the diabetic patients receiving DOAC had higher rates of major bleeding events (pooled OR 1.28 [1.14, 1.45], P<0.01, I2=50%), although with significant heterogeneity. Direct factor Xa inhibitors sub analysis also revealed a higher rate of major bleeding events (pooled OR 1.22 [1.08, 1.38], P<0.01, I2=24%), but a similar intracranial bleeding events (pooled OR 1.03 [0.86, 1.24], P=0.72, I2=0%). Conclusion Our pooled analysis suggests that diabetic patients on DOAC have an higher bleeding risk on DOAC, although with a superior embolic protection. Funding Acknowledgement Type of funding sources: None. Systemic Embolism/Stroke in DM vs. NonDM
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