BIOTRONIK AG announced that the six-month results of the ENERGY Registry were presented by Professor Raimund Erbel at the Transcatheter Cardiovascular Therapeutics (TCT 2011) conference. This all-comers registry is investigating the safety and clinical performance of the PRO-Kinetic Energy stent system in 1016 patients, including a subanalysis with small vessels, diabetic and elderly patients.
The ENERGY registry was conducted in 49 sites in 10 countries with patients who received a PRO-Kinetic Energy coronary bare metal stent. The study population included a high number of patients with acute coronary syndrome (46%), almost 30% elderly patients (≥75 years), as well as highly complex lesions (39%). The primary endpoint was six-month major adverse coronary events (MACE) defined as a composite of cardiac death, clinically driven target lesion revascularization (TLR) and myocardial infarction.
“For the treatment of coronary artery lesions, it is crucial to have a bare metal stent available that is not only highly deliverable, but also safe and effective in a broad patient population—including elderly patients and those presenting with acute coronary syndrome,”
At six months, the PRO-Kinetic Energy stent system demonstrated excellent clinical outcomes, with a MACE rate of only 4.4%. Cardiac death, myocardial infarction, target lesion revascularization rates were 0.6%, 1.3% and 2.5%, respectively. Only two cases of stent thrombosis (0.2%) were seen. Also, in the small vessel (≤2.75 mm) population, the very low number of events was confirmed with a MACE rate of 6.4% and a TLR of only 2.8%.
“For the treatment of coronary artery lesions, it is crucial to have a bare metal stent available that is not only highly deliverable, but also safe and effective in a broad patient population—including elderly patients and those presenting with acute coronary syndrome,” stated Prof. Raimund Erbel, principal investigator from the West German Heart Center in Essen, Germany. “These six-month results are excellent.”
Alain Aimonetti, Vice President of Marketing and Sales at BIOTRONIK AG added, “We are delighted that the ENERGY Registry supports our belief that the PRO-Kinetic Energy stent is an excellent platform. For years we have invested in continued development in our stent platforms, and these outstanding results are a testament to our dedication.”
The PRO-Kinetic Energy is a thin strut (60μm), cobalt chromium bare metal stent, completely sealed with a thin layer of amorphous silicon carbide, PROBIO. This passive coating reduces the interaction between the metal stent and the surrounding tissue, which makes the stent more hemocompatible.