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

Cortese B 1 , Testa L 2 , Heang TM 3 , Ielasi A 4 , Bossi I 5 , Latini RA 6 Show all authors , Lee CY 7 , Perez IS 8 , Milazzo D 9 , Caiazzo G 10 , Tomai F 11 , Benincasa S 12 , Nuruddin AA 13 , Stefanini G 14 , Buccheri D 15 , Seresini G 16 , Singh R 17 , Karavolias G 18 , Cacucci M 19 , Sciahbasi A 20 , Ocaranza R 21 , Menown IBA 22 , Torres A 23 , Sengottvelu G 24 , Zanetti A 25 , Pesenti N 25 , Colombo A 14 , EASTBOURNE Investigators

Affiliations 

  • 1 Fondazione Ricerca e Innovazione Cardiovascolare, Milan, Italy. Electronic address: [email protected]
  • 2 IRCCS Policlinico San Donato, Milan, Italy
  • 3 Pantai Hospital Ayer Keroh, Melaka, Malaysia
  • 4 Cardiology Division, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy
  • 5 Ospedale Niguarda, Milan, Italy
  • 6 A.O. Fatebenefratelli, Milan, Italy
  • 7 Sultanah Aminah Hospital Johor Bahru, Johor, Malaysia
  • 8 Hospital General Universitario de Ciudad Real, Ciudad Real, Spain
  • 9 ASP S. Giovanni di Dio, Agrigento, Italy
  • 10 Ospedale San Giuseppe Moscati, Aversa, Italy
  • 11 European Hospital, Rome, Italy
  • 12 Ospedale di Rho, Rho, Italy
  • 13 Institute Jantung Negara, Kuala Lumpur, Malaysia
  • 14 Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
  • 15 Ospedale S. Antonio Abate, Trapani, Italy
  • 16 Ospedale di Sondrio, Sondrio, Italy
  • 17 University Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 18 Metropolitan Hospital, Pireas, Greece
  • 19 Azienda Ospedaliera Ospedale Maggiore, Crema, Italy
  • 20 Sandro Pertini Hospital, Rome, Italy
  • 21 Hospital Lucus Augusti, Lugo, Spain
  • 22 Craigavon Cardiac Centre, Craigavon, Northern Ireland, United Kingdom
  • 23 Hospital Universitario de Txagorritxu, Spain
  • 24 Apollo Hospitals, Chennai, India
  • 25 Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology, and Public Health, University of Milano-Bicocca, Milan, Italy; We 4 Clinical Research, Milan, Italy
JACC Cardiovasc Interv, 2023 Jul 24;16(14):1794-1803.
PMID: 37495352 DOI: 10.1016/j.jcin.2023.05.005

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).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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