Six-month results from the DELUX registry demonstrating excellent safety and efficacy results for the Pantera Lux Paclitaxel Releasing Balloon in more than 1000 patients were presented by Ralph Toelg, MD, Segeberger Heart Center Clinic, Germany, and Thomas Schmitz, MD, Elisabeth Hospital, Germany, at the EuroPCR 2012 congress in Paris last week.
“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 revascularization rate of 1.7%.”
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 revascularization rate of 3.2%. A further analysis of the diabetic subgroup of 363 patients showed similarly low revascularization 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," remarked Dr. 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 revascularization rate of 1.7%."