Abstract Body (Do not enter title and authors here): Background: Drug-eluting balloons (DEB) are promising alternatives to drug-eluting stents (DES) for managing de novo coronary artery disease (CAD). Given the scarcity of available data, our objective was to evaluate the outcomes of DES versus DEB in CAD patients.

Methods: Databases such as PubMed, Embase, Cochrane Library, and Google Scholar were searched to identify studies comparing clinical outcomes between DCB and DES in de novo CAD patients. Using a random-effects model, pooled estimates of the mean difference (MD) and odds ratio (OR) were calculated along the 95% confidence intervals (CI), with statistical significance set at p<0.05.

Results: The pooled analysis included 19 studies with 3643 de-novo CAD patients (1588: DCB; 2055: DES). DCB was associated with a significantly lower mean lumen diameter at follow-up [MD: -0.27; 95% CI: -0.40, -0.15; p<0.0001] than DES. No statistically significant differences in mean in-stent late lumen loss [MD: 0.14; 95% CI: 0.00, 0.28], cardiovascular mortality [OR: 1.10; 95% CI: 0.57, 2.12], all-cause mortality [OR: 0.79; 95% CI: 0.45, 1.37], myocardial infarction [OR: 0.67; 95% CI: 0.41, 1.10], major adverse cardiovascular events [OR: 1.06; 95% CI: 0.67, 1.68], target lesion revascularization [OR: 1.32; 95% CI: 0.88, 2.00], and stent thrombosis [OR: 0.89; 95% CI: 0.39, 2.05] were noted.

Conclusion: While the DCB group exhibited a notable decrease in the minimum lumen diameter during follow-up compared to the DES group, no statistically significant differences were observed in other outcomes. Further studies with larger sample sizes are required to confirm this comparison.