Nine-Month Results Reported for Biotronik's Pro-Kinetic Energy Bare-Metal Stent
January 2, 2018—Tesfaldet T. Michael, MD, et al reported the 9-month results of the BIOHELIX-I clinical trial that evaluated the bare-metal Pro-Kinetic Energy (PKE) cobalt chromium coronary stent system (Biotronik). The findings are available online in Catheterization and Cardiovascular Interventions.
In the background notes to the study, the investigators advised that although drug-eluting stents constitute a majority of implants, bare-metal stents (BMSs) remain important for a subset of patients as newer-generation BMSs offer advantages with stent design improvements.
As summarized in Catheterization and Cardiovascular Interventions, the BIOHELIX-I study is a prospective, multicenter, nonrandomized, single-arm clinical trial designed to evaluate the safety and efficacy of the PKE BMS. Thirty-three study centers in the United States, Columbia, and Europe enrolled 329 patients for treatment of one target lesion (≤ 31 mm).
Eligible patients received a PKE stent(s), at least 1 month of dual antiplatelet therapy, and were followed for 36 months. The primary endpoint was the 9-month rate of target vessel failure (TVF) compared with a prespecified performance goal of 18.7% derived from previous BMS trials (mean patient age, 69 years; presented with diabetes, 28.6%). The mean lesion length was 13.7 ± 6 mm.
The investigators reported that the 9-month TVF rate was 9.06% and met the primary endpoint (P < .001). The TVF component rates were 0.95% cardiac death, 1.58% myocardial infarction, and 7.26% ischemia-driven target vessel revascularization (TVR). The ischemia-driven target lesion revascularization rate at 9 months was 6.62%.
The 9-month TVF rate of the PKE BMS was comparable to other BMSs and is a viable option for treating coronary artery disease with a low observed rate of ischemia-driven TVR that supports the safety and efficacy of this novel BMS design, concluded the investigators in Catheterization and Cardiovascular Interventions.