Key result
Essential paclitaxel-coated balloon yields ~4% 12-month TLF in de-novo small vessel disease.
Why the study?
Paclitaxel-coated balloon coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels, but early and mid-term clinical outcomes with the new Essential PCB were not established.
Cohort (n=71)
Yes
The use of a paclitaxel-coated balloon for de-novo small vessel coronary lesions is associated with low rates of target lesion failure and major adverse cardiac events at 12 months.
Hypothesis-generating for paclitaxel-coated balloons in small-vessel disease; randomized trials needed before clinical adoption.
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.
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Abellás-Sequeiros et al. (2018) conducted a cohort in de-novo coronary lesions in small vessels (n=71). Essential paclitaxel-coated balloon (PCB) was evaluated on 12-month target lesion failure (TLF) rate: a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization. The use of the Essential paclitaxel-coated balloon for treating de-novo coronary lesions in small vessels resulted in a 12-month target lesion failure rate of 4.2%.
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