Drug-coated balloons provide comparable clinical outcomes to drug-eluting stents in small coronary artery diseaseDrug-Coated Balloons Show Similar Results to Stents for Coronary Disease

Frontiers in Medicine Published September 21, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note that drug-coated balloons provide comparable clinical outcomes to drug-eluting stents in small coronary artery disease.

This meta-analysis evaluated the clinical outcomes of drug-coated balloons (DCB) compared to drug-eluting stents (DES) in 1,849 patients with de novo small coronary artery disease (reference vessel diameter $≤$2.75 mm or $≤$2.5 mm). The analysis focused on primary outcomes including nonfatal myocardial infarction, cardiac death, all-cause death, target lesion revascularization (TLR), and target-vessel revascularization (TVR).

The meta-analysis reported no significant differences between DCB and DES for any primary outcome. Specifically, the odds ratios were 0.87 for nonfatal myocardial infarction (95% CI: 0.55-1.39), 1.38 for cardiac death (95% CI: 0.66-2.88), 1.00 for all-cause death (95% CI: 0.59-1.69), 1.03 for TLR (95% CI: 0.65-1.64), and 0.76 for TVR (95% CI: 0.47-1.23). The certainty of evidence was moderate for most outcomes, while TVR was rated as low to moderate.

Several limitations were noted, including a limited number of trials, insufficient power for subgroup analyses, and imprecision. Additionally, the inclusion of open-label designs may impact the results. These findings suggest that DCB provides comparable clinical outcomes to DES for patients with small coronary artery disease, though the evidence for TVR is less certain.

How this fits prior evidence

This meta-analysis addresses a gap in comparing specific intervention devices for small coronary artery disease. While other covered evidence focuses on procedural techniques like near-styloid puncture or adjunctive therapies like acupuncture to improve outcomes, this finding specifically compares DCB to DES. The results confirm that both devices provide comparable clinical outcomes in the target population, though the evidence for TVR is of lower certainty.

A meta-analysis looked at how two different treatments compare for patients with new small coronary artery disease. The study included 1,849 patients to compare the use of drug-coated balloons (DCB) against the standard drug-eluting stents (DES).

The researchers found no significant differences between the two methods regarding major health outcomes. Both treatments showed similar results for nonfatal heart attacks, cardiac death, and all-cause death. Additionally, there was no significant difference in the need for repeat procedures in the specific area treated or the overall vessel.

Because the study included a limited number of trials and some data was imprecise, the results should be viewed with caution. While the findings suggest that drug-coated balloons are a comparable option to stents for small coronary arteries, the evidence is not yet strong enough to change standard care for everyone. Patients should talk to their doctors to decide which treatment is best for their specific heart condition.

What this means for you:

Drug-coated balloons show similar safety and success rates to stents for small coronary artery disease.

Common questions

Are drug-coated balloons as safe as stents?

The study of 1,849 patients found no significant difference between drug-coated balloons and drug-eluting stents regarding cardiac death or all-cause death. Both methods showed similar results for these major safety outcomes in patients with small coronary artery disease.

How do these treatments compare for repeat procedures?

The analysis showed no significant difference between drug-coated balloons and drug-eluting stents for target lesion revascularization or target-vessel revascularization. This means both methods performed similarly regarding the need for follow-up procedures in the treated area.

Who is this finding for?

This finding specifically concerns patients with de novo small coronary artery disease, which involves vessels with a diameter of 2.75 mm or less. If you have this condition, consult your doctor to discuss which treatment is right for you.

Study Details

Study typeMeta analysis

EvidenceLevel 1

PublishedSep 2026

View Original Abstract ↓

ObjectiveThis 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.MethodsWe 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.ResultsSix 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.ConclusionCurrent 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 Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420261500541.

Drug-coated balloons provide comparable clinical outcomes to drug-eluting stents in small coronary artery diseaseDrug-Coated Balloons Show Similar Results to Stents for Coronary Disease

How this fits prior evidence

Common questions

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Drug-coated balloons provide comparable clinical outcomes to drug-eluting stents in small coronary artery diseaseDrug-Coated Balloons Show Similar Results to Stents for Coronary Disease

How this fits prior evidence

Common questions

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