Key result
Drug-coated balloon angioplasty showed no significant difference compared to drug-eluting stents for the primary composite endpoint in patients with late or very late stent thrombosis (p=0.06).
Why the study?
Data were lacking regarding outcomes of patients with stent thrombosis treated with drug-coated balloon angioplasty.
Does paclitaxel drug-coated balloon-only angioplasty improve outcomes compared to drug-eluting stents in patients with stent thrombosis?
Observational (n=173)
No
Does paclitaxel drug-coated balloon-only angioplasty improve outcomes compared to drug-eluting stents in patients with stent thrombosis?
p-value: p=0.06
Drug-coated balloon angioplasty appears to be a viable alternative to drug-eluting stents for treating late or very late stent thrombosis, with potentially favorable cardiovascular mortality outcomes.
DCB angioplasty for stent thrombosis yields registry outcomes similar to DES; leaves open need for randomized trials before practice change.
Background: There are no data regarding the outcomes of patients with stent thrombosis (ST) being treated with drug-coated balloon (DCB) angioplasty. Our aim was to compare the outcomes of patients with ST treated with DCB vs. a drug eluting stent (DES). Methods: In this registry analysis, we identified all patients treated for ST in our institution from June 2011 until November 2019. We excluded patients who died in the cath lab, patients with uncrossable lesions, and patients treated with thrombectomy only. Patient outcomes were obtained from Hospital Episodes Statistics from NHS England. The primary endpoint of this study was the composite of cardiovascular mortality, acute coronary syndrome, or target lesion revascularisation. The data were analysed with Cox regression and Kaplan–Meier estimator plots. Results: A total of 173 patients were identified; 92 treated with DCB-only, 36 with balloon angioplasty (BA), 26 with DES, and 19 with a combination of DES and DCB. We compared the outcomes of 92 patients with DCB versus 20 patients with DES, all of which had presented with late or very late ST. There was no difference between DCB and DES in terms of the primary endpoint (p = 0.06). Multivariate analysis identified diabetes (adverse) and the use of GPIIbIIIa inhibitor (favourable) as the only independent predictors of the primary endpoint. Implantation of a DES was independently associated with worse cardiovascular mortality. Conclusions: This is the first study assessing the outcomes of patients with ST treated with DCB only. It has demonstrated that DCBs are an attractive therapeutic option with a tendency towards favourable outcomes when compared to DESs.
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Merinopoulos et al. (2025) conducted an observational in Stent thrombosis (n=173). Drug-coated balloon (DCB) angioplasty vs. Drug eluting stent (DES) was evaluated on Composite of cardiovascular mortality, acute coronary syndrome, or target lesion revascularisation (p=0.06). Drug-coated balloon angioplasty showed no significant difference compared to drug-eluting stents for the primary composite endpoint in patients with late or very late stent thrombosis (p=0.06).
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