Comparative outcomes of drug-eluting stents and drug-eluting balloons in treating in-stent restenosis.

Introduction: Several treatment modalities have been proposed and used for bare-metal in-stent restenosis (ISR). We compared the efficacy of drug-eluting balloons (DEB) versus drug-eluting stents (DES) in the treatment of ISR in terms of binary restenosis, target lesion revascularization (TLR) and late lumen loss (LLL) by coronary angiography at 6 months. Material and methods: A total of 41 patients were enrolled in the study. The patients were then randomized to the two arms of the study wherein the control group was treated by the implantation of a second-generation DES and the study group was treated with a paclitaxel-eluting DEB. Late lumen loss and any ISR (the difference between the in-segment minimal lumen diameter (MLD) after the procedure and at 6 months) was the primary end point. Secondary end points included the rate of restenosis and the rate of the combined clinical events up to 6 months, including stent thrombosis, target-lesion revascularization, myocardial infarction, and death. Results: There was a statistically significant difference between DEB and DES treatment in the immediate post-procedure outcome, with DES giving a better immediate post-procedure outcome. No significant difference was observed in late lumen loss between patients treated with either DEB or DES at 6 months follow-up. Conclusions: There was no significant difference in the late lumen loss with either DEB or DES for treatment of ISR.