The 24-month results from the DEBAS clinical trial have been presented at the VEITHsymposium (17–21 November, New York, USA). Biotronik says that DEBAS is the first investigator-initiated trial to demonstrate the efficacy and safety of a novel combination therapy for peripheral artery disease using Passeo-18 Lux drug-coated balloon and Pulsar-18 self-expanding stent to treat peripheral artery disease in a complex patient population.
“Biotronik’s drug-coated balloon and self-expanding stent have been proven to work as individual treatments for superficial artery disease. However, each approach has its respective limitations in certain vessel morphologies and clinical situations,” stated DEBAS principal investigator Patrice Mwipatayi, Royal Perth Hospital, Perth, Australia. “The results of DEBAS indicate that a hybrid approach combining Passeo-18 Lux with the thin-strut stent, Pulsar-18 may overcome some of these limitations and improve patients’ clinical outcomes, especially for the long and complex lesions seen in this trial.”
A total of 65 patients were enrolled in the prospective, multicentre, investigator-initiated DEBAS registry, with 24-month data available for 51 patients. More than half of the patients were treated for long, complex TASC D lesions, indicative of an advanced disease state. All patients were treated with the Pulsar-18 stent followed by Passeo-18 Lux drug-coated balloon. The primary endpoint was primary patency at 12 months with follow-up to 24 months. At 12 months, primary patency was very high at 92.2%, sustained at 88.2% at 24 months. Major amputation was 1.96% at 24 months, confirming the safety of combination therapy with Passeo-18 Lux and Pulsar-18.
“Pulsar-18’s thin strut design makes this stent uniquely suited for adjunctive therapy with a drug-coated balloon, as thinner struts decrease the distance between the balloon’s coating and the vessel wall. A low metal-to-artery ratio guarantees that the drug can be delivered to the vessel wall following stent implantation,” explained Mwipatayi. “Additionally, Pulsar-18’s thin struts may have a scoring effect on the lesion when the Passeo-18 Lux is inflated within the stent, potentially reducing barotrauma, or injury caused by inflation of a drug-coated balloon. These factors might improve drug uptake and lead to the outstanding primary patency seen in this trial.”
“Passeo-18 Lux and Pulsar-18 represent key technologies in the Biotronik peripheral portfolio. They have a documented history of clinical success when used as individual treatment options, and the highly encouraging results of DEBAS show that combination therapy with both can achieve even better clinical performance,” commented Alexander Uhl, Biotronik vice president marketing, Vascular Intervention.