Abstract

<i>Background</i>: Drug- eluting balloon (DEB) and drug- eluting stent (DES) are widely used in cardiovascular interventional surgery. But the long-term safety of DEB is unclear. <i>Objective</i>: To compare the efficacy and safety of DEB with DES for the treatment of de novo coronary artery disease (CAD). <i>Methods</i>: We conducted a meta-analysis of relevant studies identified in the Pubmed, Embase, and Cochrane Library databases. Random and fixed effects models were used to calculate the relative risks (RR) and standard mean differences (SMD) with 95% confidence intervals. <i>Results</i>: Nine studies in 1946 patients were included in this analysis. There was no significant difference in the primary endpoint of major adverse cardiovascular events (MACE) or in the efficacy endpoint of late lumen loss (LLL) between the DEB and DES groups. For follow-up < 12 months, there was no significant difference between DEB and DES for each MACE component, including target lesion revascularization (TLR), stent thrombosis (ST), myocardial infarction (MI), and death. However, a lower risk for MI and death was observed for DEB when the follow-up time was ≥ 12 months. <i>Conclusion</i>: DEB is equivalent to DES for the treatment of patients with de novo CAD and appears to represent a safer option for long-term treatment of this patient population.

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