DEBAS Results Support Combination Therapy With Biotronik's Passeo-18 Lux DCB and Pulsar-18 Stent

November 20, 2015—Biotronik announced that the 24-month results from the DEBAS clinical trial were presented at the VEITHsymposium in New York, New York. The investigator-initiated DEBAS trial demonstrated the efficacy and safety of combination therapy using Biotronik’s Passeo-18 Lux drug-coated balloon (DCB) and its Pulsar-18 self-expanding stent (SES) to treat peripheral artery disease in a complex patient population.

In the company’s press release, DEBAS principal investigator, Prof. Patrice Mwipatayi, MBBS, commented, “Biotronik’s DCB as well as SES 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. The results of DEBAS indicate that in 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.” Prof. Mwipatayi is from Royal Perth Hospital in Perth, Australia.

According to Biotronik, a total of 65 patients were enrolled in the prospective, multicenter 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 SES followed by Passeo-18 Lux DCB. The primary endpoint was primary patency at 12 months with follow-up to 24 months.

The company reported that at 12 months, primary patency was very high at 92.2% and was sustained at 88.2% at 24 months. The major amputation rate was 1.96% at 24 months, confirming the safety of combination therapy with Passeo-18 Lux and Pulsar-18.

The Passeo-18 Lux DCB is a combination device for treating de novo and restenotic lesions in the infrainguinal arteries. The balloon is coated with a matrix of paclitaxel and butyryl-tri-hexyl citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. The Pulsar-18
 SES features a highly flexible design and is coated with ProBio, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility. Pulsar-18 is available in diameters of 4 to 7 mm, all deliverable through a 4-F sheath.

Prof. Mwipatayi explained, “Pulsar-18’s thin strut design makes this stent uniquely suited for adjunctive therapy with a 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. 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.”