Clinical outcomes of drug-coated balloon for treatment of de novo coronary artery disease with and without diabetes.

Objectives: To retrospectively evaluate the efficacy of drug-coated balloon (DCB) in patients with de novo coronary artery disease with and without diabetes.

Methods: Patients with de novo coronary artery and undergoing percutaneous coronary intervention (PCI) with DCB were enrolled from March 2018 and March 2020, including 312 patients being divided into the diabetes group (n=110), pre-diabetes group (n=48) and non-diabetes group (n=154). The primary endpoint was major adverse cardiac events (MACE) (MACE; cardiovascular death, non-fatal myocardial infarction, target lesion revascularization, and target vessel revascularization) at 24 months.

Results: In diabetes group, the incidence of MACE at 24 months (19.1%) was higher than in the non-diabetes group (12.5%) and pre-diabetes group (10.4%) (<0.05). Cox regression revealed that diabetes (HR [hazard ratios] 2.049, 95% CI 1.056-4.284), bifurcation lesion (HR 5.255, 95% CI 2.765-9.986), Syntax score (HR 1.098, 95% CI 1.040-1.559) and hemoglobin A1c (HR 1.084, 95% CI 1.160-1.741) were independent predictors of MACE in patients performing PCI with DCB (all <0.05). However, pre-diabetes did not increase the risk of MACE (HR 1.560, 95% CI 0.542-4.490, >0.05).

Conclusion: Diabetes increased the risk of MACE in patients performing PCI with DCB.