Real-world safety and efficacy of the Essential Pro paclitaxel-coated balloon: the prospective multicenter rEpic04 registry

Introduction and objectives: Drug-coated balloons are an established therapeutic option for in-stent restenosis (ISR) and in smallvessel disease.The rEpic04 post-market clinical follow-up study evaluated the safety and efficacy profile of the Essential Pro balloon paclitaxel-coated balloon, which uses TransferTech technology (iVascular, España) in routine clinical practice.Methods: This prospective, multicenter, observational registry was conducted at 7 Spanish centers in full compliance with the European Union Medical Device Regulation (MDR) 2017/745.A total of 161 consecutive patients with 182 lesions treated with Essential Pro were enrolled.The primary endpoints were device success, defined as residual percent diameter stenosis < 30%, and procedural success.The primary clinical endpoint was target lesion failure (TLF) at 12 months.Results: The cohort was clinically complex: 47.8% of the patients had diabetes, and 67.7% had undergone a previous coronary intervention.The indications for treatment were ISR (48.4%), small-vessel disease (39%), diffuse disease (18.1%) and bifurcation lesions (15.4%).Device success was achieved in 96.6% of cases and procedural success in 94.5%; bailout stenting was required in 2.2%.At 12 months, the TLF rate was 7.1%, primarily driven by target lesion revascularization (5.5%).Subgroup analysis showed a significantly lower TLF rate in small vessels (1.4%) compared with the remaining lesions (P = .02),whereas the TLF rate in ISR lesions was 12.5%.No thrombosis or device-related mechanical failures were reported.Conclusions: The Essential Pro balloon was safe and effective across a complex spectrum of coronary lesions.The TLF rate was significantly lower in small vessels and higher in ISR, consistent with previous series.These exploratory subgroup findings support the safety and efficacy profile of the device in real-world clinical practice.