Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry. (17th October 2020)

• Record Type: Journal Article
• Authors: Caiazzo, Gianluca; De Michele, Mario; Golino, Luca; Manganiello, Vincenzo; Fattore, Luciano
• Other Names: Rodriguez Alfredo E. Academic Editor.
• Is Part Of: Journal of interventional cardiology. Volume 2020(2020)
• Publication Date: 2020-10-17
• Subjects: Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.1206
• DOI: 10.1155/2020/8865223
• Languages: English
• ISSNs: 0896-4327

Abstract

Abstract : Background . Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. Methods and Results . We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003–16.761, p = 0.509 ). Conclusions . In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.