May 1, 2026European Heart Journal Supplements
Drug–coated Balloon Versus Drug–eluting Stent in De Novo Small–vessel Coronary Disease: Updated Meta–analysis of Randomized Trials
Key result
Drug-coated balloons show no benefit over drug-eluting stents for 12-month MACE in small-vessel coronary disease.
- RR 0.99
- 95% CI 0.63-1.55
- n=972
Why the study?
Drug-coated balloons offer a leave-nothing-behind strategy in de novo small-vessel coronary disease, but randomized evidence comparing them to contemporary drug-eluting stents was synthesized to clarify clinical outcomes.
Does a drug-coated balloon strategy reduce 12-month MACE compared to drug-eluting stents in patients with de novo small-vessel coronary disease?
Key Points
- To evaluate the safety and clinical efficacy of drug-coated balloons compared to drug-eluting stents for treating de novo small-vessel coronary disease.
- Conducted a systematic review and meta-analysis of randomized controlled trials evaluating drug-coated balloon-only strategies versus contemporary drug-eluting stents in de novo small coronary vessels (≤3.0 mm).
- Evaluated trial-defined 12-month major adverse cardiac events (MACE) as the primary endpoint and ischemia-driven target lesion revascularization (TLR) as the secondary endpoint.
- Calculated pooled risk ratios (RR) using a random-effects model and quantified statistical heterogeneity with the I² statistic.
- In the primary endpoint analysis across two trials (n=972), 12-month MACE occurred in 5.6% (6/108) vs 7.5% (8/106) in PICCOLETO II and 7.5% vs 7.3% in BASKET-SMALL 2, demonstrating no significant difference (pooled RR 0.99, 95% CI 0.63–1.55; I²=0%).
- Ischemia-driven target lesion revascularization across two trials (n=442) occurred in 5.6% (6/108) vs 5.6% (6/106) in PICCOLETO II and 4.4% (5/114) vs 2.6% (3/114) in RESTORE SVD China (pooled RR 1.20, 95% CI 0.50–2.85; I²=0%).
Study Design
Type
Meta-Analysis (n=972)
Structured PICO
Does a drug-coated balloon strategy reduce 12-month MACE compared to drug-eluting stents in patients with de novo small-vessel coronary disease?
P
Population
972 patients with de novo small-vessel coronary disease (≤3.0 mm) included in a meta-analysis comparing drug-coated balloons to drug-eluting stents with 12-month follow-up.
I
Intervention
Drug-coated balloon (DCB-only strategy)
C
Comparator
Contemporary drug-eluting stents (DES)
O
Outcome
12-month major adverse cardiac events (MACE; trial-defined)composite
Main Result
Relative Risk: 0.99 (95% CI 0.63–1.55)
Drug-coated balloons offer a comparable alternative to drug-eluting stents for de novo small-vessel coronary disease at 12 months, supporting a 'leave-nothing-behind' strategy.
Limitations
- Requires larger trials powered for patient-centered endpoints
- Requires standardized definitions
- Lack of large trials powered for patient-centered endpoints
- Lack of standardized definitions
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Small native coronary artery disease may safely be treated with DCB after successful predilatation. We have a potential benefit of leaving behind an intact vessel without an armor, without a stent. Therefore, we don't expect any thrombotic events, and no prolonged dual antiplatelet therapy is necessary. In drug-coated balloons, you just need 4 weeks of dual antiplatelet therapy.”
RMRoxana MehranInterventional cardiologist, Icahn School of Medicine at Mount Sinai
“The utility of this is not to replace DES. It's really to treat lesions in truly small vessels where we know there's going to be an issue with DES.”
SDSteen Dalby KristensenCardiologist, Aarhus University Hospital
“It's a nice and interesting study, but to be frank I think it is too small to change my practice. I would like to see more data.”
Implication
DCB strategy may lower MACE in small-vessel PCI; extends RCT evidence supporting leave-nothing-behind approach.
Abstract
Background Drug–coated balloons (DCB) enable a “leave–nothing–behind” strategy in de novo small–vessel coronary disease, potentially reducing metal burden while maintaining efficacy. We synthesized randomized evidence versus contemporary drug–eluting stents (DES). Methods Systematic search for randomized controlled trials comparing DCB–only versus DES in de novo small coronary vessels (≤3.0 mm). Primary endpoint: 12–month major adverse cardiac events (MACE; trial–defined). Secondary endpoint: ischemia–driven target lesion revascularization (TLR) when available. Risk ratios (RR) were pooled using a random–effects model; heterogeneity was assessed with I². Results Two trials reporting comparable 12–month MACE were included (n=972). In PICCOLETO II, MACE occurred in 6/108 (5.6%) with DCB and 8/106 (7.5%) with DES. In BASKET–SMALL 2, 12–month MACE was 7.5% with DCB and 7.3% with DES (Figure 1). Overall, DCB was not associated with a difference in MACE versus DES (pooled RR 0.99, 95% CI 0.63–1.55; I²=0%) (Figure 2). For ischemia–driven TLR (2 trials, n=442), rates were low: PICCOLETO II 6/108 (5.6%) vs 6/106 (5.6%); RESTORE SVD China 5/114 (4.4%) vs 3/114 (2.6%). The pooled RR for ischemia–driven TLR was 1.20 (95% CI 0.50–2.85; I²=0%) (Figure 3). Conclusions In de novo small–vessel PCI, DCB and contemporary DES showed comparable 12–month clinical outcomes with low revascularization rates. DCB appears a reasonable alternative in selected lesions, warranting larger trials powered for patient–centered endpoints and standardized definitions.Figure 1 Figure 2 Figure 3
Discussion
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Cite This Study
Meco et al. (2026) conducted a meta-analysis in De novo small-vessel coronary disease (n=972). Drug-coated balloon (DCB) vs. Drug-eluting stent (DES) was evaluated on 12-month major adverse cardiac events (MACE; trial-defined) (RR 0.99, 95% CI 0.63-1.55). Drug-coated balloons showed no difference in 12-month major adverse cardiac events compared to drug-eluting stents in de novo small-vessel coronary disease (RR 0.99; 95% CI 0.63-1.55).