April 28, 2017 — Biotronik’s Pulsar-18 bare metal stent (BMS) has yielded high primary patency in a real-world setting, according to the 12-month results of the BIOFLEX PEACE all-comers registry. The findings were presented this week at the Charing Cross Symposium, April 25-28 in London. Outcomes of the BIOLUX 4EVER study were also presented on the main stage, revealing 12-month results numerically comparable to drug-eluting stents (DES) when the Pulsar-18 was used in combination with the Passeo-18 Lux drug-coated balloon (DCB).
The 12-month results from the BIOFLEX PEACE All-Comers Registry revealed findings for the first time for the entire patient cohort for the Pulsar-18 in the treatment of femoral popliteal lesions in a real-world setting. During the presentation at the Charing Cross Symposium, lead investigator Michael Lichtenberg, M.D., highlighted the 73.6 percent primary patency and 96.2 percent freedom from clinically driven target lesion revascularization (fTLR) in 164 patients. “These results are in line with already published data for the Pulsar stent from controlled trials, thus confirming the stent’s efficacy for a broader range of patients and lesions,” commented Lichtenberg, Vascular Center Clinic, Arnsberg, Germany.
In the BIOLUX 4EVER trial, physicians used the combination of the Pulsar-18 BMS and the Passeo-18 Lux DCB to treat superficial femoral artery (SFA) lesions. Koen Deloose, M.D., AZ Sint-Blasius, Dendermonde, Belgium presented the full 12-month (395 days) outcomes of this trial, with 89.9 percent primary patency and 91.6 percent fTLR in a cohort of 120 patients.
“The 12-month outcomes of the BIOLUX 4EVER trial indicate the value of a combined approach that provides physicians with more options and versatility when treating SFA lesions while achieving DES-like results,” commented Deloose. “While DES is limited by the need to fully cover the lesion with a stent and fully treat the lesion with paclitaxel, the new combination approach of a DCB and BMS means that there is now the freedom to determine how much support is necessary based on each vessel’s unique anatomy and lesion characteristics for a more tailored approach. Following full lesion coverage with the DCB, if full lesion stenting is deemed necessary, we have the results of BIOLUX 4EVER to give physicians the confidence of a good outcome; should the physician decide to minimize the metal burden, partial (focal) stenting can be used, which is not an option with DES.”
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