Biotronik today said 2-year results from a trial studying the novel use of both drug-coated balloon and self-expanding stents to treat peripheral artery disease showed a high rate of primary patency sustained over the 24 months. Data from the trial was presented at the VEITHsymposium in New York City this week.
Biotronik’s Passeo-18 Lux drug-coated balloons and Pulsar-18 self-expanding stents were used in the study, which aimed to examine the combined treatment in a complex patient population. Patients were treated with the Pulsar-18 stent, followed by the 18 Lux DCB.
“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,” Dr. Patrice Mwipatayi of Australia’s Royal Perth Hospital said in a press release.
Data from the 65-patient study showed half of the patients were treated for long complex TASC D lesions which generally occur during an advanced disease state. The study reported a primary patency rate of 92.2% at 12 months, and 88.2% at 24 months. Rate of major amputation was roughly 2% at 24 months.
“Pulsar-18’s thin strut design makes this stent uniquely suited for adjunctive therapy with DCB, as thinner struts decrease the distance between the DCB’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,” Dr. Mwipatayi said in prepared remarks. “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 DCB. 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. Biotronik has established a rigorous clinical program to more fully investigate combination therapy as an alternative to existing drug-eluting approaches,” vascular intervnetion marketing veep Dr. Alexander Uhl said in a prepared statement.