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Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ 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 OPN™ NCB in a real-world population. From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE). 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 OPN™ 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. For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, 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. • The OPN™ – a twin-layer, highly non-compliant balloon (NCB) – allows application of pressures >30 atm. • This ultra-high pressure balloon device has been shown to be effective in native coronary lesions. • This is the first study systematically assessing the utility and safety of the OPN™ in in-stent restenosis (ISR). • Albeit using pressures >30 atm with OPN™ devices, few complications occurred in our complex ISR cohort. • Moreover, we observed clinical outcomes comparable or lower than previous seen in ISR studies. [ABSTRACT FROM AUTHOR]

Current guidelines recommend vitamin K antagonists (VKAs) for the treatment of a left ventricular thrombus (LVT). However, direct oral anticoagulants (DOACs) show superior safety and efficacy compared with VKAs in most thromboembolic disorders. Nevertheless, DOACs remain poorly investigated for the treatment of LVT. To describe the thrombus resolution rate and clinical efficacy of DOACs versus VKAs in patients with LVT, we analyzed consecutive patients with confirmed LVT from a multicenter echocardiography database. Echocardiograms and clinical end points were evaluated independently. The thrombus resolution rate and clinical outcomes were compared according to the underlying anticoagulation regimen. In total, 101 patients were included (17.8% women, mean age 63.3 ± 13.2 years), 50.5% had recently experienced a myocardial infarction. The mean left ventricular ejection fraction was 36.6 ± 12.2%. DOACs versus VKAs were used in 48 and 53 patients, respectively. The median follow-up was 26.6 (interquartile range 11.8;41.2) months. Among patients receiving VKAs compared with DOACs, the thrombus resolved more rapidly within the first month in those taking VKAs (p = 0.049). No differences were seen between the 2 groups with respect to major bleedings, strokes, and other thromboembolic events. In each group, LVT recurred in 3 of the subjects (a total of 6) after discontinuation of anticoagulation. In conclusion, DOACs appear to be a safe and effective alternative to VKAs for the treatment of LVTs, but the rate of thrombus dissolution within 1 month after initiation of anticoagulation appears to be higher with VKAs. A sufficiently powered randomized trial is required to definitively define the role of DOACs in the treatment of LVT., (Copyright © 2023 Elsevier Inc. All rights reserved.)