Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry
Bernardo Cortese, Luca Testa, Gaetano Di Palma, Tay Mok Heang, Irene Bossi, Amin Ariff Nuruddin, Alfonso Ielasi, Maurizio Tespili, Ignacio Sánchez Pérez, Diego Milazzo, Susanna Benincasa, Azeem Latib, Michele Cacucci, Gianluca Caiazzo, Giuseppe Seresini, Fabrizio Tomai, Raymundo Ocaranza, Alfonso Torres, Anna Perotto, Francesco Bedogni, Antonio Colombo
Abstract
AIMS: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. METHODS: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.