Meta-Analysis Comparing Drug-Coated Balloon Versus Plain Old Balloon Angioplasty for In-Stent Restenosis of Coronary Arteries

Abstract

Despite the advent of newer stents, in-stent restenosis has been a persistent and formidable challenge. Trials have demonstrated the superiority of drug-coated balloons over plain old balloon angioplasty. A recent AGENT IDE PRESTO (Prevention of REStenosis with Tranilast and its Outcomes) trial highlighted the need for a more comprehensive understanding; therefore, we conducted a meta-analysis to elucidate their respective clinical outcomes. A literature search was conducted by 2 investigators (SS and MH) using MEDLINE (EMBASE and PubMed) using a systematic search strategy by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) until November 1, 2023. CRAN-R software was used for statistical analysis. The quality assessment was performed using the Cochrane Risk of Bias tool (Supplementary Table 5). We included 6 studies with a total of 1,171 patients. Our analysis showed decreased odds of multiple outcomes with statistically significant results, including target vessel revascularization (odds ratio [OR] 0.33, confidence interval [CI] 0.19 to 0.57), target vessel failure (OR 0.30, CI 0.09 to 0.99), target lesion revascularization (OR 0.22, CI 0.10 to 0.46), restenosis (OR 0.1343, CI 0.06 to 0.27), and major adverse cardiac events (OR 0.2 CI 0.12 to 0.37). Although myocardial infraction and all-cause mortality showed decreased odds with all-cause mortality at 0.8 (95% CI 0.363 to 2.09), and myocardial infarction at 0.6 (95% CI 0.0349 to 1.07), the reductions did not reach statistical significance. Our analysis by scrutinizing 6 randomized controlled trials favored drug-coated balloons over plain old balloon angioplasty. However, extensive research for deeper understanding cannot be overemphasized.