Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients

医学 内科学 冠状动脉疾病 心肌梗塞 临床终点 支架 心脏病学 人口 药物洗脱支架 西罗莫司 再狭窄 不利影响 介入心脏病学 血运重建 临床试验 外科 环境卫生
作者
Bernardo Cortese,Luca Testa,Tay Mok Heang,Alfonso Ielasi,Irene Bossi,Roberto Adriano Latini,Chuey Yan Lee,Ignacio Sánchez-Pérez,Diego Milazzo,Gianluca Caiazzo,Fabrizio Tomai,Susanna Benincasa,Amin Ariff Nuruddin,Giulio G. Stefanini,Dario Buccheri,Giuseppe Seresini,Ramesh Singh,George Karavolias,Michele Cacucci,Alessandro Sciahbasi,Raymundo Ocaranza,Ian Menown,Alfonso Torres,Gunasekaran Sengottvelu,Anna Zanetti,Nicola Pesenti,Antonio Colombo
出处
期刊:Jacc-cardiovascular Interventions [Elsevier]
卷期号:16 (14): 1794-1803 被引量:26
标识
DOI:10.1016/j.jcin.2023.05.005
摘要

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