P6074Clinical outcomes following the treatment of sirolimus coated balloon in coronary artery stenosis in real world population: results from nanolute registry

Abstract

Aim: Our aim was to investigate one year outcomes in patients treated with world's first Sirolimus coated balloon for coronary artery stenosis in real world population. Methods: All patients treated with sirolimus coated balloon (SCB) in the period June 2012 to January 2017 were included in the study analysis. The study is still on-going. The primary endpoints of the study were major adverse cardiac event (MACE) which is composite of cardiac death, target vessel myocardial infarction (TV-MI) and target vessel/lesion revascularization (TVR/TLR) at 6 months and procedural success. Procedural success is defined as technical and angiographic success in the absence of a MACE at hospital discharge. Secondary endpoint was incidence of MACE at 12 months. Results: 465 SCB were employed to treat 418 lesions in 393 patients. Diabetes mellitus accounted for 44.78% and acute coronary syndrome accounts for 47.7% of the total population. The mean balloon length and diameter of the balloon were 22.18±7.22 mm and 2.68±0.45 mm respectively. Procedural success was reported as 99.74%. PCI was successful in all patients and all balloons were deployed successfully in the target lesion except in 1 patient vessel dissection was reported. 94.4% patients completed 6 months of follow up and the reported MACE was 3.5%. The incidence of MACE at 12 months was 4.78% in 335 (85.24%) patients. The MACE was mainly driven by TLR (4.18%), TV-MI (0.30%) and cardiac death (0.30%). The MACE rates were reported as 4.55% and 5.48% for diabetic patients and patients with long lesions in small vessels respectively. Conclusion: In real world setting, world's first Sirolimus coated balloon was found to be safe and effective in treating coronary stenosis. The use of SCB appears to be associated with an acceptable occurrence of outcomes considering the greater complexity of the patient groups like diabetic patients and patients with long lesions in small vessels.