Long-term outcomes following drug-coated balloons versus thin-strut drug-eluting stents for treatment of in-stent restenosis in acute coronary syndrome (ACS dragon-registry)

Abstract Background The long-term outcomes of patients with in-stent restenosis (ISR) presenting with Acute Coronary Syndrome (ACS) are not well studied. This study aims at investigating the outcomes of patients with drug-eluting stents (DES)-ISR presenting with ACS undergoing percutaneous coronary intervention (PCI) with DCB or thin strut-DES. Methods Consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin-DES or paclitaxel-DCB for DES-ISR were enrolled. Primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint [DOCE, cardiac death, TLR, and target vessel myocardial infarction (TV-MI)]. Propensity-score matching was used to adjust for baseline differences. Results A total of 1,317 patients were included in the pooled analysis of whom 585 (44.4%) were treated with a thin-DES and 732 (55,6%) with drug-coated balloons. In the crude analysis of patients with ACS (N = 697) undergoing PCI for ISR, thin-DES vs. DCB showed similar outcomes for TLR (HR = 1.21, 95% CI 0.78–1.86; P = 0.400), TVR (HR = 0.91, 95% CI 0.62–1.34; P = 0.641), MI (HR = 1.25, 95% CI 0.82–1.86; P = 0.281), TV-MI (HR = 0.91, 95% CI 0.43–1.90; P = 0.793), CV death (HR = 0.76, 95% CI 0.27–2.09; P = 0.589), and DOCE (HR = 1.04, 95% CI 0.70–1.54; P = 0.840). After propensity score matching (N = 606), the HRs remained non-significant for TLR (1.08, 95% CI 0.69–1.69; P = 0.731), TVR (0.88, 95% CI 0.59–1.31; P = 0.523), MI (1.24, 95% CI 0.80–1.91; P = 0.336), TV-MI (0.93, 95% CI 0.43–2.05; P = 0.865), CV death (0.75, 95% CI 0.26–2.18; P = 0.602), and DOCE (0.98, 95% CI 0.65–1.46; P = 0.904). Conclusions In patients with acute coronary syndrome undergoing percutaneous coronary intervention for in-stent restenosis, treatment with thin-DES was associated with a numerical reduction in the rates of TLR and DOCE compared with DCB. However, these differences did not achieve statistical significance in either the crude or propensity score–matched analyses.