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Multicenter Study
. 2023 Jul 24;16(14):1794-1803.
doi: 10.1016/j.jcin.2023.05.005.

Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry

Bernardo Cortese  1 , Luca Testa  2 , Tay M Heang  3 , Alfonso Ielasi  4 , Irene Bossi  5 , Roberto A Latini  6 , Chuey Y Lee  7 , Ignacio S Perez  8 , Diego Milazzo  9 , Gianluca Caiazzo  10 , Fabrizio Tomai  11 , Susanna Benincasa  12 , Amin A Nuruddin  13 , Giulio Stefanini  14 , Dario Buccheri  15 , Giuseppe Seresini  16 , Ramesh Singh  17 , George Karavolias  18 , Michele Cacucci  19 , Alessandro Sciahbasi  20 , Raymundo Ocaranza  21 , Ian B A Menown  22 , Alfonso Torres  23 , Gunasekaran Sengottvelu  24 , Anna Zanetti  25 , Nicola Pesenti  25 , Antonio Colombo  14 ; EASTBOURNE Investigators
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Free article
Multicenter Study

Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry

Bernardo Cortese et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications.

Objectives: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.

Methods: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.

Results: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).

Conclusions: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).

Keywords: DCB; all-comer registry; drug-coated balloon; sirolimus-coated balloon.

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Conflict of interest statement

Funding Support and Author Disclosures The study was an independent, investigator-driven study which received fundings by Envision Scientific. This society had no role in the protocol definition, selection of centers, conduction of the study and interpretation of the results. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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