Compared with plain old balloon angioplasty, both drug-coated balloons and drug-eluting stents reduced major adverse cardiovascular events (OR 0.34; 95% CI 0.24-0.50 and OR 0.37; 95% CI 0.25-0.54).
Meta-Analysis (n=3,820)
Does drug-coated balloon or drug-eluting stent reduce major adverse cardiovascular events compared with plain old balloon angioplasty in patients with coronary in-stent restenosis?
In patients with coronary in-stent restenosis, both drug-coated balloons and drug-eluting stents significantly reduce major adverse cardiovascular events compared to plain old balloon angioplasty, with comparable clinical efficacy between the two active treatments.
Odds Ratio: 0.34 (95% CI 0.24–0.5)
BACKGROUND: Drug-coated balloons (DCBs) are now a Food and Drug Administration-approved treatment option for the management of in-stent restenosis (ISR) based on superior outcomes compared with plain old balloon angioplasty (POBA) alone. However, the efficacy of DCB compared with drug-eluting stent (DES; repeat stenting) for ISR is uncertain, with prior studies showing inferiority of DCB. We aimed to compare the outcomes of DES, DCB, or POBA in patients with coronary ISR. METHODS: We searched PubMed, EMBASE, and clinicaltrials.gov databases (until August 1, 2025) for randomized clinical trials that compared DCB, DES, or POBA alone for ISR. Outcomes included major adverse cardiovascular events, target lesion revascularization, all-cause mortality, cardiovascular mortality, stent thrombosis, late lumen loss, and postprocedure minimum lumen diameter. RESULTS: From 18 randomized clinical trials that randomized 3820 patients with ISR, at mean follow-up of 18 months, compared with POBA, both DCB and DES were associated with reduction in major adverse cardiovascular events (odds ratio, 0.34 95% CI, 0.24-0.50; odds ratio, 0.37 95% CI, 0.25-0.54) driven by reduction in target lesion revascularization (odds ratio, 0.28 95% CI, 0.15-0.50; odds ratio, 0.21 95% CI, 0.10-0.42). DCB had a lower postprocedure minimum lumen diameter but lower late lumen loss (mean difference, -0.16 95% CI, -0.29 to -0.04 mm) compared with DES with no difference in other clinical outcomes. CONCLUSIONS: In patients with ISR, DCB reduced major adverse cardiovascular events/target lesion revascularization compared with POBA. There was no significant difference in clinical outcomes between DCB and DES. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42024598433.
Maqsood et al. (Wed,) conducted a meta-analysis in in-stent coronary restenosis (n=3,820). Drug-coated balloon (DCB) or Drug-eluting stent (DES) vs. Plain old balloon angioplasty (POBA) was evaluated on major adverse cardiovascular events (OR 0.34, 95% CI 0.24-0.50). Compared with plain old balloon angioplasty, both drug-coated balloons and drug-eluting stents reduced major adverse cardiovascular events (OR 0.34; 95% CI 0.24-0.50 and OR 0.37; 95% CI 0.25-0.54).