Italy: Study on Drug-Coated Balloon vs. Everolimus-Eluting Stent

Defying the recent trend of using everolimus-eluting stent (EES) in patients with SVD lesions, a recent study has found a novel drug-coated balloon (DCB) to be better than EES. The findings of the study were published in the journal JACC: Cardiovascular Interventions.

According to results from the PICCOLETO II trial, the new-generation DCB outperformed EES in terms of late lumen loss and resulted in comparable diameter stenosis, binary restenosis, and short-term clinical outcome.

Small vessel coronary artery disease (SVD) is one of the most attractive fields of application for DCB. Until now, several devices have been compared with drug-eluting stents in this setting, with different outcomes. The aim of the PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) study by Bernardo Cortese, San Carlo Clinic, Milano, Italy, and colleagues was to compare the performance of a novel drug-coated balloon (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.

PICCOLETO II is a follow-up to the PICCOLETO study, in which patients with stable or unstable angina undergoing PCI of small coronary vessels (≤ 2.75 mm) were randomized to the Dior DCB (Eurocor) or Taxus DES (Boston Scientific).

The PICCOLETO II trial is an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial. The trial enrolled a total of 232 patients with de novo SVD lesions at 5 centers between May 2015 and May 2018. They were randomized to receive either DCB or EES.

Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.

Key findings of the study include:

• After a median of 189 days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm).
• Percent diameter stenosis and minimal lumen diameter were not significantly different.
• At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group.
• There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%) and vessel thrombosis (1.8% vs. 0%) in the DES arm.

"In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome," wrote the authors.

This trial also shows the clinical noninferiority of the DCB strategy after 12 months.

"Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial," is published in the journal JACC: Cardiovascular Interventions.

DOI: https://www.jacc.org/doi/10.1016/j.jcin.2020.08.035