Reducing metal burden in superficial femoral artery therapy could effectively reduce restenosis rates, according to various studies by biomedical device company Biotronik presented at the 2017 congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
Dr. Martin Funovics from Medical University of Vienna presented results from preclinical data on the use of low chronic outward force (COF) versus high COF stents. This was further supported by the interim results of the BIOFLEX COF randomized controlled trial that established lower COF results in lower restenosis rates. This could change the way physicians plan treatment of superficial femoral artery disease when implanting self-expanding stents. Evaluating efficacy using "normalized, cumulative percent restenosis" offers an accurate way to systematically assess restenosis with a higher sensitivity and specificity than the traditional Doppler ultrasound method, according to the firm.
The BIOLUX 4EVER study looked into the use of full-lesion coverage with a drug-coated balloon followed by a bare metal stent. Presented by Dr. Koen Deloose from the AZ Sint-Blasius Hospital in Dendermonde, Belgium, the Passeo-18 Lux and Pulsar-18 study devices generated a primary patency rate of 89.9% at 12 months in average lesion lengths of 8.3 cm. At the 24-month follow-up, primary patency was numerically higher with the drug-coated balloon and bare metal stent.
Exploring how to translate all the presented data into clinical practice, Dr. Ralf Langhoff from Sankt-Gertrauden Krankenhaus in Berlin, shared a treatment strategy algorithm based on clinically available evidence on the Passeo-18 Lux drug-coated balloon, the Pulsar-18 bare metal stent, and the combined use of both. Starting treatment with the Passeo-18 Lux, the physician can decide whether the lesion also needs to be stented based on the response to the drug-coated balloon. To test this algorithm, he further proposed an outline for a trial.