Safety and efficacy of the Essential Pro paclitaxel drug-coated balloon in de novo coronary lesions

Introduction and objectives: Drug-coated balloons (DCBs) are an increasingly used therapeutic strategy for the treatment of de novo artery lesions (DNLs).This study aimed to assess the safety and efficacy profile of a new DCB in patients with DNLs.Methods: This is a prospective, single-center, consecutive cohort study of patients with DNL undergoing coronary angioplasty with a new second-generation paclitaxel-coated balloon.The 3 main endpoints were myocardial infarction, target lesion revascularization, and target vessel revascularization.Baseline variables, including patient and procedural characteristics, were collected.Results: This study included a total of 185 consecutive patients with 211 treated lesions (mean age, 68.4 ± 11.5 years; 8.7% women) undergoing a percutaneous coronary intervention with a DCB for DNLs.Device delivery was successful in 100%.Final angiographic assessment showed final dissection in 2.4%, TIMI grade < 3 flow in 1.4%, residual percent diameter stenosis > 10% in 14.4%, and residual percent diameter stenosis > 30% in 7.7%.Bailout stenting was required in 12.4%.A suboptimal DCB result occurred in 13.7%.At the 30-day follow-up, there were no deaths, 1 myocardial infarction (0.5%), no target lesion revascularization, target vessel revascularization in 1.1%, and 2 patients (1.1%) were readmitted to hospital due to a coronary syndrome.At 617 days, corresponding to the 75 th percentile of follow-up, there were no deaths, and Kaplan-Meier estimates for myocardial infarction, target lesion revascularization, and target vessel revascularization were 2.2% (95%CI, 0-4.7%), 1.1% (95%CI, 0-2.7%), and 4.5% (95%CI, 1.2-7.8%)respectively.The most common indications were small vessel disease (66.8%), high bleeding risk (36.6%), and bifurcation lesions (11.4%).Patients at high bleeding risk had a more adverse clinical profile.No statistical differences in outcomes were observed according to indication.Conclusions: Among patients with DNLs, the use of the Essential Pro DCB (iVascular, Spain) was associated with high device deliverability and low rates of adverse clinical events during follow-up.Outcomes were consistent across the main clinical indications evaluated.These findings support the feasibility and safety of DCB angioplasty in this real-world cohort.