Ralph Toelg, Segeberger Heart Center Clinic, Germany, and Thomas Schmitz, Elisabeth Hospital, presented at EuroPCR 2012 six-month results from the DELUX registry which demonstrated positive safety and efficacy outcomes for the Pantera Lux Paclitaxel Releasing Balloon (Biotronik) in more than 1000 patients.
The registry enrolled a population of mostly in-stent restenotic patients (87.7%), yet still had a very low major adverse cardiac event (MACE) rate of 8.7% and a revascularisation rate of 3.2%. A further analysis of the diabetic subgroup of 363 patients showed similarly low revascularisation rates of 4.4%.
“Patients with a complex disease such as in-stent restenosis (ISR) or diabetes represent a cohort that continues to return to the catheter laboratory with repeat restenosis. Seeing these low event rates in such a high-risk patient group in the DELUX study suggests that the Pantera Lux can be a viable alternative in these types of cases,” said Toelg. “The data suggests that treatment with the Pantera Lux Paclitaxel Releasing Balloon is highly promising for DES restenosis and especially encouraging in patients with a previous bare metal stent (BMS), where we see a very low revascularisation rate of 1.7%.”
The Pantera Lux Paclitaxel Releasing Balloon is a novel treatment for restenotic coronary artery lesions after drug-eluting or bare metal stenting. The device is based on the highly deliverable Pantera semicompliant balloon, which is then coated with a matrix of proven antiproliferative paclitaxel and the biocompatible butyryl-tri-hexyl citrate (BTHC) excipient, which enables an optimal drug transfer to the target lesion tissue.
DELUX is a prospective, multicentre, international registry evaluating the Pantera Lux Paclitaxel Releasing Balloon in 1064 patients in a real-world setting. The primary endpoint was the 6-month cumulative MACE rate defined as a composite of all death, non-fatal myocardial infarction and clinically driven target vessel revascularisation. Major secondary outcomes are cumulative MACE rates at 1 and 12 months.