Abstract
To evaluate the efficacy of drug-coated balloon (DCBs) therapy in de novo lesions compared with in-stent restenosis (ISR) in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). 149 patients with NSTE-ACS who underwent DCB-only strategy between March 2019 and March 2022 were retrospectively analyzed.Among those, 64 individuals underwent optical coherence tomography (OCT) prior to DCB dilatation. All patients were divided into de novo (n = 94) and ISR group (n = 55) group. The primary endpoint was major adverse cardiovascular event (MACE) at 18 months, Secondary endpoints were target lesion revascularization (TLR) and late lumen loss (LLL). Plaque morphology of culprit lesions associated with MACE was analyzed using OCT imaging. During 18 months follow-up period, there were no statistically differences in MACE (15% vs 13%; hazard ratio [HR]: 0.89, 95% CI: 0.38-2.1; P = .80), TLR (14% vs 15%; HR: 1.14, 95% CI: 0.43-3.00; P = .79), LLL (0.16 ± 0.46 vs 0.09 ± 0.38; P = .41) and restenosis (19% vs 16%; P = .70) between the de novo and the ISR groups. Cox regression analysis showed that TIMI thrombus burden grade ≥ 3, small vessels (<2.75 mm) were associated with the prevalence of MACE (P < .05). OCT image analysis revealed a trend towards a higher prevalence of calcific tissues (HR: 2.92, 95% CI: 0.88-9.7; P = .08), macrophages (HR: 3.12, 95% CI: 0.94-10.38; P = .06), and red thrombus (HR: 2.82, 95% CI: 0.90-8.90; P = .08) in patients with MACE compared to those without. The Kaplan-Meier curve demonstrated that the cumulative 18 months incidence of MACE in patients of small vessel with thrombus were significantly higher than that in the other patients (log-rank: P = .046). DCB-only strategy for treatment of de novo lesions showed similar efficacy to ISR lesions in NSTE-ACS patients for MACE, TLR, LLL, and restenosis at an 18 months follow-up. High thrombus burden and small vessel disease were associated with the prevalence of MACE.