Drug-Coated Balloon Angioplasty vs Plain Balloon Angioplasty in patients with coronary In-Stent Restenosis: A systematic review and meta-analysis of randomized controlled trials.

ABSTRACT

BACKGROUND: In-stent restenosis (ISR) remains a significant challenge in interventional cardiology despite advancements in stent technology. Drug-coated balloons (DCBs), which deliver antiproliferative agents directly to the vessel wall, have emerged as a promising alternative to plain balloon angioplasty for ISR treatment. This meta-analysis evaluates the efficacy of DCBs compared to plain balloon angioplasty in patients with coronary ISR. METHODS: A comprehensive search of PubMed and Embase was conducted on June 27, 2024. The search identified randomized controlled trials comparing DCBs and plain balloon angioplasty for ISR treatment. Six trials involving 1,322 patients met the inclusion criteria. Quality was assessed with the Cochrane Risk of Bias tool. Data extraction and statistical analysis were performed using RevMan software, assessing heterogeneity with the I2 statistic and publication bias using funnel plots. RESULTS: The analysis showed that DCBs significantly reduced late in-stent and in-segment luminal loss (P < 0.001) and target lesion revascularization (P = 0.02) compared to plain balloon angioplasty. Major adverse cardiovascular events and the combined endpoint of target lesion revascularization, myocardial infarction, and death also showed highly significant improvements with DCB treatment (P < 0.00001 and P = 0.0002, respectively). However, no significant effect was observed on myocardial infarction and mortality rates. CONCLUSION: DCBs significantly reduce in-stent late luminal loss, target lesion revascularization, and major adverse cardiovascular events compared to plain balloon angioplasty.