Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

BackgroundWe compared efficacy of bare-metal stent (BMS) and drug-eluting balloon (DEB) combination vs BMS alone, in patients with non-ST elevation acute coronary syndrome treated with percutaneous coronary intervention (PCI).MethodsPatients with non-ST elevation myocardial infarction (NSTEMI) or unstable angina (UA) were randomized to BMS only or BMS + DEB group. Angiographic follow-up was performed after 6 months. The primary endpoints were binary in-stent restenosis (ISR) and late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR), stent thrombosis (ST), and new acute coronary syndrome (ACS).ResultsA total of 85 patients were enrolled, 44 (BMS) and 41 (BMS + DEB). The median age was 67 (36-84) years and 68 (80%) were male. Fifty-two patients (61.2%) had NSTEMI and 33 patients (38.8%) UA. There was no difference in patient demographics, risk factors, and clinical characteristics, except for more smokers in the BMS + DEB group 18/41 (43.9%) vs 9/44 (20.5%). At follow-up, no significant difference in binary ISR was found; p = 0.593, but LLL was significantly lower in the BMS + DEB group 0.68 (0.00-2.15) mm vs 0.22 (0.00-2.35) mm; p = 0.002. The difference in major adverse cardiac events (MACE) rate combining TLR, ST, and ACS, between the groups was also non-significant, 29.5% (BMS) vs 24.4% (BMS + DEB); p = 0.835. One patient had a subacute ST (BMS + DEB) due to clopidogrel resistance.ConclusionPatients treated with BMS + DEB combination for non-ST elevation acute coronary syndrome had significantly less LLL in comparison to patients treated with BMS alone but without an impact on patient clinical outcomes.