4EVER and PEACE Data Support Biotronik's Pulsar Stents to Treat SFA Disease

October 31, 2013—Biotronik (Lake Oswego, OR) announced the results from two independent clinical studies concerning the company's Pulsar-18 self-expanding stent system in the treatment of superficial femoral artery (SFA) disease. The prospective, multicenter 4EVER study's 24-month results were backed up by 12-month results from the multicenter, prospective PEACE registry. In both studies, the Pulsar stent's efficacy data compared favorably with study results for other bare-metal stents, stated the company.

According to Biotronik, the 4EVER study investigated both the acute and long-term performance of 4-F–compatible devices in SFA lesions. The study examined the efficacy of Pulsar stents and the feasibility of treating patients with 4-F devices from Biotronik, including the Fortress 4-F sheath and Astron Pulsar and Pulsar-18 stents.

At 24 months, the 4EVER study's full cohort of 120 patients showed a 72.3% primary patency rate and a 82.7% rate of freedom from target lesion revascularization (TLR) with no significant difference between calcified and noncalcified lesions. These results compared favorably with reported data from other bare-metal stent studies (DURABILITY II, SUPERA SFA Registry, and STROLL) at the same time point and in similar lesion lengths and patient demographics.

Results of the PEACE registry were taken from the enrolled 200 patients, with 118 patients receiving follow-up after 12 months. At 12 months, the primary patency rate was 79.5% and the freedom from TLR rate was 81%, with no significant difference between popliteal versus nonpopliteal disease and diabetics versus nondiabetics.

The data were presented in September at CIRSE 2013, the annual congress of the Cardiovascular and Interventional Radiological Society in Barcelona, Spain. Marc Bosiers, MD, presented the 4EVER study results. Prof. Günther Wittenberg, MD, presented the PEACE registry results. Dr. Bosiers is Chief of Surgery at AZ Sint-Blasius in Dendermonde, Belgium. Prof. Wittenberg is Chief of the Institute for Diagnostic and Interventional Radiology at the Evangelisches Krankenhaus in Bielefeld, Germany.

In Biotronik's press release, Prof. Wittenberg commented, “The results of these two studies have clearly demonstrated the efficacy of treating symptomatic SFA disease.” Dr. Bosiers added, “Both 4EVER at 24 months and PEACE at 12 months confirm that the Pulsar stent with optimal radial force combined with high flexibility is favorable to stents that concentrate mainly on high radial force in treating SFA disease.”