Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon

Background: Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correc-tion of stent under-expansion and neointimal compression using the twin-layer OPNTM' highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPNTM' NCB in a real-world population. Methods: From an ongoing registry, consecutive ISR patients treated with the OPNTM' NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target le-sion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE).Results: Totally, 208 ISR lesions were treated in 188 patients (mean age 68 +/- 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre-and post-dilatation (mean pressure 33 +/- 6 atm) with the OPNTM' NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died.Conclusions: For ISR treatment, using the super non-compliant OPNTM' balloon at very high pressures is safe. More -over, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.(c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).