Twelve-Month Results Presented for Biotronik's Pro-Kinetic Energy BMS

May 15, 2012—Biotronik, Inc. (Lake Oswego, OR) announced that 12-month results of the ENERGY registry demonstrated a 6.5% rate of major adverse cardiac events (MACE), which confirms previously presented outcomes from this study. The data were presented at the EuroPCR 2012 conference in Paris.

In a press release, Biotronik stated that the ENERGY registry is investigating the safety and clinical performance of the company's Pro-Kinetic Energy bare-metal stent (BMS) system in 1,016 patients from a broad-based population. The registry's Principal Investigator is Prof. Raimund Erbel, MD, from the West German Heart Center in Essen, Germany.

The Pro-Kinetic Energy device is a thin-strut (60 µm), cobalt-chromium BMS that is completely sealed with a thin layer of the company's ProBio, an amorphous silicon carbide. This passive coating makes the stent more hemocompatible by reducing the interaction between the metal stent and the surrounding tissue, stated the company.

As summarized in the company's press release, the ENERGY investigators performed an analysis of each predefined subgroup: patients with acute coronary syndrome (ACS), patients with small vessels, diabetic patients, and elderly patients. The company noted that in the ENERGY study population, 46% of patients had ACS, approximately 30% of patients were elderly (age ≥ 75 years), and 39% of patients presented with highly complex lesions.

In addition to the low MACE rate, the 12-month results included rates of cardiac death, myocardial infarction, and target lesion revascularization of 0.9%, 1.8%, and 3.8%, respectively. In the ACS subgroup, which the company noted is a more high-risk population and is thus associated with higher event rates, MACE was only 6.2% at 1 year.

“Nowadays, we are seeing more and more drug-eluting stents (DES) being used due to their increased efficacy over BMS. However, especially for patients with ACS, it is very important to have high-performing BMS at hand. Pro-Kinetic Energy is such a high performer with outstanding deliverability and good efficacy that it can be more often used as an alternative to DES,” commented Prof. Erbel in the Biotronik press release.