SELUTION SLR sirolimus-eluting balloon compared with the Pantera Lux paclitaxel drug-coated balloon in the management of de novo coronary lesions

Introduction and objectives: Drug-coated balloons are an emerging stentless therapeutic option for the treatment of de novo coronary artery disease.Although paclitaxel-coated balloons remain the current standard, concerns regarding delayed vascular healing and potential local toxicity have driven the development of sirolimus-eluting balloons (SEB).This study aimed to compare the safety and efficacy profile of the novel SELUTION SLR SEB with the established Pantera Lux paclitaxel-coated balloon in a real-world cohort of patients with de novo coronary artery disease.Methods: We conducted a prospective, single-center registry included 257 patients with 316 de novo coronary lesions treated with drug-coated balloon-only percutaneous coronary intervention from 2023 through 2024.Patients were treated with either the SELUTION SLR sirolimus-eluting balloon or the Pantera Lux paclitaxel-coated balloon.A 1-year follow-up was conducted to assess major adverse cardiovascular events, target lesion failure (TLF), and target lesion revascularization (TLR), which were descriptively compared across groups.Results: Baseline clinical and angiographic characteristics were well balanced.At the 1-year follow-up, the overall rate of major adverse cardiovascular events was 5.8%, with no significant differences across treatment groups.The rates of TLF and TLR were low and comparable.However, patients treated with the SELUTION SLR experienced fewer procedural complications, including a lower rate of mild coronary dissections (6.7% vs 14.7%; P = .043)and no-reflow events (0.0% vs 2.7%; P = .036). Conclusions:The SELUTION SLR SEB demonstrated efficacy vs the Pantera Lux, with fewer procedural complications.These findings support the selective use of SELUTION SLR as a stentless treatment strategy and highlight the need for larger randomized trials to confirm long-term comparative outcomes.