Biotronik studies assess ways to treat SFA lesions with reduced, no metal burden

Biotronik touted studies that were presented at the 2017 CIRSE congress, concluding that reducing metal burden in superficial femoral artery therapy could effectively lessen restenosis rates.

In-stent restenosis is an obstacle in SFA treatment, but some researchers believe that reducing the stent, or metal, load may help reduce restenosis rates. One session at CIRSE, chaired by Dr. Jos van den Berg from Ospedale Regionale di Lugano in Switzerland, focused on clinical options to treat SFA lesions with reduced or no metal burden, including drug-coated balloons and drug-eluting stents.

The symposium included a registry of more than 700 patients with SFA lesions treated with Biotronik’s Passeo-18 Lux drug-coated balloon. The registry had a primary patency rate of 85% and a freedom from target lesion revascularization  rate of 94.5%. The bailout stenting rate was 20%, despite the high moderate-severe calcification rates of 42% in lesions with an average length of 9.4 centimeters.

The session also included a study designed to evaluate the need for an drug-eluting stent in the treatment of SFA. The study compared the use of a drug-eluting stent with a group of patients treated with a drug-coated balloon, followed by a bare metal stent.

The DCB + bare-metal stent group had a primary patency rate of nearly 90% after 12 months in average lesion lengths of 8.3 centimeters. After two years, primary patency was higher with the DCB + bare-metal stent group compared to the DES group.

“The emergence of drug-coated balloons has revolutionized SFA intervention by eliminating or reducing the need for permanent metallic implants. However, adjunctive stents are still required to scaffold the vessel wall,” van den Berg reportedly said. “As the presence and amount of metal may contribute to inflammatory response, potentially leading to restenosis, it seems logical that using thin-strut, low COF stents such as Pulsar is one way to reduce the metal burden.”

“Adopting a reactive approach gives us the opportunity to reduce metal burden by only implanting the stent length that’s needed, while benefiting from the anti-proliferative effect of DCBs. This versatility is, for example, not possible with DES.”

“These exciting data support our belief that the REsponse Adapted Combination Therapy (REACT) approach allows the physician to adopt a flexible, evidence-based approach for treating the SFA with minimal vessel burden,” Alexander Uhl, VP of marketing for Biotronik’s vascular intervention group, added.