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

Otto S, Diaz VAJ, Weilenmann D, Cuculi F, Nuruddin AA, Leibundgut G, Alfonso F, Wan Ahmad WA, Pyxaras S, Rittger H, Steen P, Gaede L, Schulze C, Woehrle J, Rosenberg M, Waliszewski MWW (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Bmc Cardiovascular Disorders BioMed Central

Book Volume: 23

Journal Issue: 1

DOI: 10.1186/s12872-023-03187-x

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.

Authors with CRIS profile

Harald Rittger
Luise Gaede Department of Medicine 2 – Cardiology and Angiology

Additional Organisation(s)

FAU Profilzentrum Licht.Materie.Quantentechnologien (FAU LMQ)

Involved external institutions

Klinikum Fürth DE Germany (DE) Álvaro Cunqueiro hospital ES Spain (ES) B. Braun Melsungen AG DE Germany (DE) Klinikum Aschaffenburg DE Germany (DE) Friedrich-Schiller-Universität Jena DE Germany (DE) Klinikum Friedrichshafen DE Germany (DE) National Heart Institute Malaysia MY Malaysia (MY) Universitätsspital Basel CH Switzerland (CH) Luzerner Kantonsspital (LUKS) CH Switzerland (CH) Hospital Universitario de La Princesa ES Spain (ES) University of Malaya (UM) / Universiti Malaya MY Malaysia (MY) Kantonsspital St.Gallen CH Switzerland (CH)

How to cite

APA:

Otto, S., Diaz, V.A.J., Weilenmann, D., Cuculi, F., Nuruddin, A.A., Leibundgut, G.,... Waliszewski, M.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). https://doi.org/10.1186/s12872-023-03187-x

MLA:

Otto, Sylvia, et al. "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 (2023).

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