Evaluating drug-coated balloon versus drug-eluting stent for the treatment of small coronary artery disease: a meta-analysis and systematic review

Abstract

Objective This meta-analysis aimed to compare the efficacy and safety of drug-coated balloons (DCB) vs. drug-eluting stents (DES) in patients with de novo small coronary artery disease. Methods We systematically searched PubMed, Embase, Cochrane Library, and Web of Science from inception to March 18, 2024, for randomized controlled trials comparing DCB with DES in small-vessel coronary disease (reference vessel diameter ≤2.75 mm or ≤2.5 mm). Primary outcomes included nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization (TLR), and target-vessel revascularization (TVR). Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using fixed- or random-effects models depending on heterogeneity. Certainty of evidence was assessed using the GRADE framework. The protocol was registered with PROSPERO. Results Six unique RCT cohorts (eight publications) comprising 1,849 patients were included. No significant differences were observed between DCB and DES for nonfatal myocardial infarction (OR = 0.87, 95% CI: 0.55–1.39; I2 = 39%), cardiac death (OR = 1.38, 95% CI: 0.66–2.88; I2 = 0%; four trials), all-cause death (OR = 1.00, 95% CI: 0.59–1.69; I2 = 0%), TLR (OR = 1.03, 95% CI: 0.65–1.64; I2 = 25%), or TVR (OR = 0.76, 95% CI: 0.47–1.23; I2 = 34%). Subgroup analysis suggested a potential TLR benefit in very small vessels (≤2.25 mm), but this finding was exploratory with no significant interaction across subgroups. All outcomes were rated as moderate certainty, except TVR (low to moderate), with downgrading primarily due to imprecision and open-label design limitations. Conclusion Current randomized evidence indicates that DCB provides comparable clinical outcomes to DES in patients with de novo small coronary artery disease. However, the limited number of trials and insufficient power for subgroup analyses underscore the need for larger, well-powered randomized studies to define the optimal strategy, particularly in specific patient and vessel subsets. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420261500541.