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Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels: initial experience with the Essential paclitaxel-coated balloon

Abellas-Sequeiros, Rosa Albaa; Benezet, Javierb; Agarrado Luna, Antoniob; Oneto Otero, Jesúsb; Déry, Jean-Pierrea; Cieza, Tomasa; DeLarochellière, Roberta; Duocastella, Lluisc; Gomez, Alexc; Molina, Mariac; Asmarats, Lluisa; Pelletier-Beaumont, Emiliea; Puri, Rishia; Rodés-Cabau, Josepa

doi: 10.1097/MCA.0000000000000617
Original research: PDF Only

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.

aQuebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada

bDepartment of Cardiology, Hospital de Jerez de la Frontera, Jerez de la Frontera, Cadiz,

ciVascular, Barcelona, Spain

Correspondence to Josep Rodés-Cabau, MD, Quebec Heart and Lung Institute, Laval University, 2725 Chemin Ste-Foy, G1V4G5, Quebec City, Quebec, Canada Tel: +418 656 8711; fax: +418 656 4544; e-mail: josep.rodes@criucpq.ulaval.ca

Received December 15, 2017

Received in revised form February 4, 2018

Accepted February 5, 2018

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