Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels: initial experience with the Essential paclitaxel-coated balloon. Issue 6 (September 2018)

• Record Type: Journal Article
• Authors: Abellas-Sequeiros, Rosa Alba; Benezet, Javier; Agarrado Luna, Antonio; Oneto Otero, Jesús; Déry, Jean-Pierre; Cieza, Tomas; DeLarochellière, Robert; Duocastella, Lluis; Gomez, Alex; Molina, Maria; Asmarats, Lluis; Pelletier-Beaumont, Emilie; Puri, Rishi; Rodés-Cabau, Josep
• Is Part Of: Coronary artery disease. Volume 29:Issue 6(2018:Sep.)
• Publication Date: 2018-09
• Subjects: angioplasty -- paclitaxel-coated balloon -- de-novo lesions -- small vessels; Coronary heart disease -- Periodicals; Coronary Disease -- Indexes; Coronary Disease -- Periodicals; 616.123005
• DOI: 10.1097/MCA.0000000000000617
• Languages: English
• ISSNs: 0954-6928

Abstract

Abstract : Background: Paclitaxel-coated balloon (PCB) coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels. This study with the new Essential PCB aimed to evaluate early and mid-term clinical outcomes following angioplasty with the Essential PCB in the treatment of de-novo lesions in small vessels. Patients and methods: We included all patients who underwent PCB angioplasty for treating de-novo coronary lesions in small vessels (reference diameter <2.5 mm) between October 2015 and June 2016 in 2 centres. The primary endpoint was the 12-month target lesion failure (TLF) rate: a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization. The secondary endpoints were rates of target vessel failure and global major adverse cardiac events (MACE). Results: A total of 71 patients (comprising 71 lesions) were included, with a mean age of 66±11 years. A 56% were diabetic and 70% had an acute coronary syndrome as an indication for coronary revascularization. The mean vessel diameter and lesion length were 2.21±0.41 and 20.7±9.2 mm, respectively. Predilatation was performed in 85.9% of patients. The median diameter, length, and inflation pressure of the Essential balloon were 2.0 [interquartile range (IQR): 2.0–2.5] mm, 20 (IQR: 15–30) mm, and 12±2 atmospheres, respectively. Angiographic success was achieved in 97.2% of cases, and bail-out stenting was required in nine (12.7%) cases. The incidence of TLF at the 12-month follow-up was 4.2%, with a target lesion revascularization rate of 4.2%. Target vessel failure and global MACE rates were 4.2 and 9.9%, respectively. Conclusion: Use of the Essential PCB for treating de-novo coronary lesions in small vessels was safe, with low TLF and MACE rates at the 12-month follow-up.