Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience

Background The use of drug eluting balloons (DEB) remains clinically relevant in the contemporary era of drug eluting stents percutaneous coronary interventions (DES-PCI), especially in the setting of in stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. Methods 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical center between 2010-2021. Clinical endpoints included mortality and major adverse cardiac events at 1 year. Clinical outcomes were adjusted for multiple confounders. Results Mean age (65.9±11.0 vs. 66.1±10.5, p=0.73), and percentage of female patients (16.6% vs. 18.2%, p=0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and prior myocardial infarction (p<0.01 for all), and presented more frequently with acute coronary syndrome (40.0% vs. 34.4%, p=0.01) compared to patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs. 19.6%, p=0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1-year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1-year (p=0.55). Conclusions In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates, as compared to DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at one year following PCI.