Otto, Sylvia and Diaz, Victor Alfonso Jimenez and Weilenmann, Daniel and Cuculi, Florim and Nuruddin, Amin Ariff and Leibundgut, Gregor and Alfonso, Fernando and Wan Ahmad, Wan Azman and Pyxaras, Stylianos and Rittger, Harald and Steen, Philip and Gaede, Luise and Schulze, Christian and Woehrle, Jochen and Rosenberg, Mark and Waliszewski, Matthias W. W. (2023) Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: Rationale, methodology and design of the SCORE trial. BMC CARDIOVASCULAR DISORDERS, 23 (1). ISSN 1471-2261, DOI https://doi.org/10.1186/s12872-023-03187-x.
Full text not available from this repository.Abstract
BackgroundA decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis.MethodsThe objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.DiscussionSince there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient.
| Item Type: | Article |
|---|---|
| Funders: | UNSPECIFIED |
| Uncontrolled Keywords: | Drug-coated balloon; Sirolimus; De novo lesions; In-stent stenosis; Re-stenosis; Percutaneous transluminal coronary angioplasty |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine |
| Depositing User: | Ms Zaharah Ramly |
| Date Deposited: | 22 Nov 2023 07:47 |
| Last Modified: | 22 Nov 2023 07:47 |
| URI: | http://eprints.um.edu.my/id/eprint/38395 |
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