Comparative Efficacy of Drug-Eluting Balloon vs. Drug-Eluting Stent for In-Stent Restenosis in Stable Ischemic Heart Disease: A Retrospective Study

Abstract

Objectives: This study aimed to compare the efficacy and safety of Drug-Eluting Balloons (DEB) versus Drug-Eluting Stents (DES) in the treatment of In-Stent Restenosis (ISR) among patients with Stable Ischemic Heart Disease (SIHD). Methodology: A retrospective observational study was conducted from October 2023 to October 2024 at a tertiary care center. A total of 200 patients were enrolled—100 treated with DEB and 100 with DES. Baseline demographic, clinical, and angiographic characteristics were assessed. The primary outcome was the incidence of Major Adverse Cardiovascular Events (MACE) at 12 months, defined as a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary outcomes included rates of restenosis and repeat revascularization. Statistical analyses were performed using SPSS version 26, with p-values < 0.05 considered statistically significant. Results: At the 12-month follow-up, the DEB group demonstrated a significantly lower incidence of MACE (16%) compared to the DES group (24%) (p = 0.04). Restenosis occurred in 18% of the DEB group versus 28% of the DES group (p = 0.03). TLR rates were 10% in the DEB group and 15% in the DES group (p = 0.32), while repeat revascularization was observed in 14% of DEB patients versus 21% of DES patients (p = 0.06). These findings suggest a clinical advantage of DEB in ISR management. Conclusion: DEB may be a superior alternative to DES in reducing the risk of MACE and restenosis in patients with ISR. Further randomized controlled trials are recommended to substantiate these findings and guide clinical decision-making.