PEACE I All-Comers Registry Supports Biotronik's Pulsar-18 for Treating Femoropopliteal Lesions

June 13, 2014—Biotronik announced the publication of clinical results from the PEACE I All-Comers Registry by Michael Lichtenberg, MD, et al in The Journal of Endovascular Therapy (2014;21:373–380). The company stated that along with earlier results from the 4EVER trial, PEACE I confirms the safety and efficacy of the company’s 4-F Pulsar-18 stent for treating advanced cases of femoropopliteal disease. The 12-month PEACE data and the 24-month 4EVER data were presented in September at CIRSE 2013, the annual congress of the Cardiovascular and Interventional Radiological Society in Barcelona, Spain. 

According to Biotronik, the PEACE I trial was a multicenter, all-comers, prospective registry that enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2–5). There were 118 patients who received the scheduled 12-month follow-up. All patients underwent a revascularization procedure via implantation of the Pulsar-18 stent. The average lesion length was 11.2 cm, and approximately 52% of treated lesions were classified as either TASC C or TASC D, which is indicative of an advanced disease state.

At 12 months, the end results of the PEACE I registry demonstrated a primary patency rate of 79.5% and a freedom from target lesion revascularization rate of 81%, with no significant difference between popliteal versus nonpopliteal lesions and diabetics versus nondiabetics. The 12-month results also show that Rutherford category improved significantly after Pulsar-18 stent implantation, with 79.8% of patients improving by at least one Rutherford category and an improvement in ankle-brachial index to 0.86 ± 0.1 compared to a baseline of 0.63 ± 0.14 (P < .00001), indicating that patients experienced less claudication. Patients were also more mobile at 12 months, as demonstrated by an improvement in a pain-free walking distance of 516 ± 370.7 meters compared to a baseline of 14.4 ± 50.8 meters (P < .00001).

Dr. Lichtenberg, the study’s lead investigator, is from the Vascular Center Clinic in Arnsberg, Germany. In Biotronik’s press release, he commented, “The Pulsar-18’s ProBio coating, which reduces platelet activation and aggregation and promotes faster endothelialization, could explain the similarity in results for diabetics and nondiabetics. The PEACE I results support the theory that the 4-F Pulsar-18 stent can be just as effective as 6-F stents in treating long femoropopliteal lesions, including TASC C and D lesions. The advantage of the Pulsar-18 stent system is that it offers the potential for complete 4-F revascularization, which means faster recovery time and improved patient comfort.”