1. Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.
- Author
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Wańha W, Iwańczyk S, Januszek R, Wolny R, Tomasiewicz B, Kuliczkowski W, Reczuch K, Pawlus P, Pawłowski TZ, Kuźma Ł, Kubler P, Niezgoda P, Kubica J, Gil RJ, Pawłowski TF, Gąsior M, Jaguszewski M, Wybraniec M, Witkowski A, Kowalewski M, D'Ascenzo F, Greco A, Bartuś S, Lesiak M, Grygier M, Wojakowski W, and Cortese B
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Treatment Outcome, Time Factors, Risk Factors, Angioplasty, Balloon, Coronary instrumentation, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention mortality, Prosthesis Design, Europe, Myocardial Infarction mortality, Myocardial Infarction etiology, Cardiac Catheters, Coronary Artery Disease therapy, Coronary Artery Disease mortality, Coronary Artery Disease diagnostic imaging, Sirolimus administration & dosage, Sirolimus adverse effects, Drug-Eluting Stents, Registries, Coronary Restenosis etiology, Coronary Restenosis diagnostic imaging, Coronary Restenosis mortality, Coronary Restenosis therapy, Coated Materials, Biocompatible, Cardiovascular Agents administration & dosage, Cardiovascular Agents adverse effects
- Abstract
Background: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting., Methods: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up., Results: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P =0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P =0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P =0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P =0.329), target vessel revascularization (14.0% versus 13.1%; P =0.822), myocardial infarction (7.2% versus 4.5%; P =0.186), all-cause death (5.7% versus 4.2%; P =0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P =0.242) between DES and SCB treatment., Conclusions: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years., Competing Interests: None.
- Published
- 2024
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