Key result
DCB reduces MACE and TLR versus POBA and matches DES for in-stent restenosis.
Why the study?
Do drug-coated balloons or drug-eluting stents reduce major adverse cardiovascular events compared to plain old balloon angioplasty in patients with coronary in-stent restenosis?
Meta-Analysis (n=4,238)
Do drug-coated balloons or drug-eluting stents reduce major adverse cardiovascular events compared to plain old balloon angioplasty in patients with coronary in-stent restenosis?
In patients with coronary in-stent restenosis, drug-coated balloons and drug-eluting stents both significantly reduce MACE and target lesion revascularization compared to conventional angioplasty, with comparable clinical outcomes between the two active treatments.
Positions DCB as a viable stent-sparing alternative to repeat stenting.
OBJECTIVES: The SELUTION SLR 014 In-stent Restenosis (SELUTION4ISR) trial showed noninferiority of DCB for the outcome of target lesion failure (TLF) when compared with standard of care (80% DES and 20% POBA). It was notable that in the DCB vs DES subgroup analysis there was a numerically higher rate of TLF with DCB (15.3% vs 7.1%). The authors aimed to re-evaluate the outcomes of drug-eluting stent (DES), drug-coated balloon (DCB), or plain old balloon angioplasty (POBA) in patients with coronary in-stent restenosis (ISR). METHODS: The authors searched PubMed and EMBASE databases for randomized clinical trials (RCTs) that compared these 3 percutaneous revascularization strategies for ISR until March 15, 2026. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization, all-cause mortality, cardiovascular mortality, and stent thrombosis. RESULTS: From 19 RCTs that randomized 4238 patients with ISR at mean follow-up of 19.6 months, there was a significant reduction in MACE and TLR with both DCB (OR, 0.35; 95% CI, 0.24-0.52 and OR, 0.28; 95% CI, 0.16-0.49, respectively) and DES (OR, 0.35; 95% CI, 0.24-0.52 and OR, 0.22; 95% CI, 0.12-0.42, respectively) when compared with POBA. There were no significant differences in clinical outcomes between DCB and DES. CONCLUSIONS: In patients with ISR, DCB reduced MACE/TLR when compared with POBA. There were no clinical differences between DCB and DES even after inclusion of the SELUTION4ISR trial, thus suggesting that DCB are reasonable alternative to repeat stenting in patients presenting with ISR.
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Maqsood et al. (2026) conducted a meta-analysis in coronary in-stent restenosis (ISR) (n=4,238). Drug-coated balloon (DCB) vs. Plain old balloon angioplasty (POBA) was evaluated on major adverse cardiovascular events (MACE) (OR 0.35, 95% CI 0.24-0.52). In patients with coronary in-stent restenosis, drug-coated balloons significantly reduced MACE compared with conventional angioplasty (OR 0.35; 95% CI 0.24-0.52), with no clinical differences vs DES.
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