ESSENTIAL ISR is a prospective, multicenter and single arm study that sought to assess the efficacy of essential paclitaxel-eluting balloon, in the setting of ISR.
The primary end-point was OCT derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) at 6 months and target lesion failure (TLF) rate at 6, 12 and 24 months, defined as the composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization (TLR).
OCT and QCA outcomes
The OCT analysis showed an in-segment maximal area stenosis of mean 51.4 ± 13% and median 53% (IQR 46.4-59.5).
In DES-ISR subgroup 52.6 ± 10% and 55.2% (IQR 49.3-58.5).
QCA showed an in-segment LLL of 0.25±0.43 mm with only 2 patients showing binary restenosis (> 50%).
Incidence of TLF was 13.3% at 24 months with all events corresponding to TLR since no cardiac death, myocardial infarction or thrombosis occurred.
In this study, essential DEB with TransferTech coating nanotechnology, showed a good and sustained efficacy in prevention of recurrent ISR (mostly of DES). This new DEB could perform comparably to the most evidence-supported DEB
“No class effect exists for DEB. This new DEB seems to perform like the best DEB available” -. said Dr. De la Torre, during his presentation at EuroPCR 2019.
About essential DEB
essential is a paclitaxel eluting balloon with a concentration of 3µg/mm2 and a proprietary coating technology TransferTech, consisting in a nanotechnology drop dosage system that yields a multilayer microcrystalline thin coating for a faster drug absorption rate.