BIOTRONIK, a leading manufacturer of cardio- and endovascular devices, announced the publication of clinical results from the PEACE I All-Comers Registry in The Journal of Endovascular Therapy. Along with earlier results from the 4EVER trial, PEACE I confirms the safety and efficacy of the Pulsar-18 stent with positive patency results, further establishing the benefits of 4 French (4F) intervention in treating even more advanced cases of femoropopliteal disease.
The PEACE I trial was a multicenter, all-comers, prospective registry that enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5), 118 of whom received their scheduled 12-month follow-up. All patients underwent a revascularization procedure via implantation of the Pulsar-18 stent. Average lesion length was 11.2 cm and approximately 52 percent of treated lesions were classified as
either TASC C or TASC D, indicative of an advanced disease state.
At 12 months, end results of the PEACE I registry demonstrated a primary patency rate of 79.5 percent with a freedom from target lesion revascularization (TLR) at a rate of 81.0 percent, with no significant difference between popliteal vs. non-popliteal lesions and diabetics vs. non-diabetics. The 12 month results also reveal that Rutherford category improved significantly after Pulsar-18 stent implantation, with 79.8 percent of patients improving by at least one Rutherford category, and an improvement in ABI to 0.86±0.10 compared to a baseline of 0.63±0.14 (p<0.00001), meaning patients experienced less claudication. Patients were also more mobile at 12 months, as demonstrated by an improvement in pain-free walking distance of 516±370.7 metres compared to a baseline of 14.4±50.8 meters (p<0.00001).
”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 non-diabetics,” hypothesized lead investigator Dr. Michael Lichtenberg, FESC, Vascular Center Clinic, Arnsberg, Germany.
“The PEACE I results support the theory that the 4F Pulsar-18 stent can be just as effective as 6F 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 4F revascularization, which means faster recovery time and improved patient comfort,”
said Dr. Lichtenberg.
“4-French intervention has shown to be superior in terms of wound complication rates, lower procedure cost and greater patient comfort with shorter ambulation time,” explained Dr. Alexander Uhl, Vice President Marketing, BIOTRONIK Vascular Intervention. “We have invested heavily in studies aimed at providing data to further support Pulsar stents in a variety of clinical settings, and we look forward to the results of the ongoing BIOFLEX PEACE II study, which will provide up to 24-month data on Pulsar-18’s performance in a much wider cohort of patients.”
About Pulsar-18
The Pulsar-18 self-expanding stent is part of a wide portfolio of 4F peripheral intervention solutions from BIOTRONIK, which includes the Fortress 4F Introducer Sheath, the Cruiser-18 guide wire and Passeo-18 balloons. The stent is made from nitinol, a highly biocompatible metal, and features an innovative, highly flexible thin strut construction.
The PEACE I trial was a multicenter, all-comers, prospective registry that enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5), 118 of whom received their scheduled 12-month follow-up. All patients underwent a revascularization procedure via implantation of the Pulsar-18 stent. Average lesion length was 11.2 cm and approximately 52 percent of treated lesions were classified as
either TASC C or TASC D, indicative of an advanced disease state.
At 12 months, end results of the PEACE I registry demonstrated a primary patency rate of 79.5 percent with a freedom from target lesion revascularization (TLR) at a rate of 81.0 percent, with no significant difference between popliteal vs. non-popliteal lesions and diabetics vs. non-diabetics. The 12 month results also reveal that Rutherford category improved significantly after Pulsar-18 stent implantation, with 79.8 percent of patients improving by at least one Rutherford category, and an improvement in ABI to 0.86±0.10 compared to a baseline of 0.63±0.14 (p<0.00001), meaning patients experienced less claudication. Patients were also more mobile at 12 months, as demonstrated by an improvement in pain-free walking distance of 516±370.7 metres compared to a baseline of 14.4±50.8 meters (p<0.00001).
”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 non-diabetics,” hypothesized lead investigator Dr. Michael Lichtenberg, FESC, Vascular Center Clinic, Arnsberg, Germany.
“The PEACE I results support the theory that the 4F Pulsar-18 stent can be just as effective as 6F 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 4F revascularization, which means faster recovery time and improved patient comfort,”
said Dr. Lichtenberg.
“4-French intervention has shown to be superior in terms of wound complication rates, lower procedure cost and greater patient comfort with shorter ambulation time,” explained Dr. Alexander Uhl, Vice President Marketing, BIOTRONIK Vascular Intervention. “We have invested heavily in studies aimed at providing data to further support Pulsar stents in a variety of clinical settings, and we look forward to the results of the ongoing BIOFLEX PEACE II study, which will provide up to 24-month data on Pulsar-18’s performance in a much wider cohort of patients.”
About Pulsar-18
The Pulsar-18 self-expanding stent is part of a wide portfolio of 4F peripheral intervention solutions from BIOTRONIK, which includes the Fortress 4F Introducer Sheath, the Cruiser-18 guide wire and Passeo-18 balloons. The stent is made from nitinol, a highly biocompatible metal, and features an innovative, highly flexible thin strut construction.
