Key result
Drug-coated balloons match drug-eluting stents for clinical outcomes in small coronary artery disease.
Why the study?
The comparative efficacy and safety of drug-coated balloons versus drug-eluting stents in patients with de novo small coronary artery disease remain uncertain.
Does the use of paclitaxel-coated balloons provide comparable efficacy and safety to drug-eluting stents in reducing adverse clinical events and revascularization in patients with de novo small coronary artery disease?
Meta-Analysis (n=1,849)
Does the use of paclitaxel-coated balloons provide comparable efficacy and safety to drug-eluting stents in reducing adverse clinical events and revascularization in patients with de novo small coronary artery disease?
Odds Ratio: 0.87 (95% CI 0.55–1.39)
Absolute Event Rate: 3.77% vs 4.31%
Current randomized evidence indicates that paclitaxel-coated balloons provide comparable safety and efficacy to drug-eluting stents for treating de novo small coronary artery disease, supporting their use as a viable stent-free alternative.
Supports DCB as alternative to DES in de novo small vessel disease; confirms comparable safety and efficacy across six RCTs.
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; I 2 = 39%), cardiac death (OR = 1.38, 95% CI: 0.66–2.88; I 2 = 0%; four trials), all-cause death (OR = 1.00, 95% CI: 0.59–1.69; I 2 = 0%), TLR (OR = 1.03, 95% CI: 0.65–1.64; I 2 = 25%), or TVR (OR = 0.76, 95% CI: 0.47–1.23; I 2 = 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.
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Gao et al. (2026) conducted a meta-analysis in De novo small coronary artery disease (n=1,849). Drug-coated balloon vs. Drug-eluting stent was evaluated on Nonfatal myocardial infarction (OR 0.87, 95% CI 0.55-1.39). Drug-coated balloons provided comparable clinical outcomes to drug-eluting stents in patients with de novo small coronary artery disease, with no significant difference in nonfatal myocardial infarction (OR 0.87).
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