Author + information
- Tesfaldet Michael1,
- Gert Richardt2,
- Alexandra Lansky3,
- Robert J. Carney4,
- Muhammed Akram Khan5,
- Abbas Shehadeh6,
- Uwe Zeymer7 and
- Saurabh Gupta8
- 1Cardiovascular Department, University of South Florida, Tampa, FL
- 2Heart Center, Bad Segeberger Kliniken, Bad Segeberg, Germany
- 3Heart and Vascular Clinical Research Program, Yale University School of Medicine, New Haven, CT
- 4Tyler Cardiovascular Consultants, Tyler, TX
- 5North Dallas Research Associates, Cardiac Center of Texas, McKinney, TX
- 6Saint Michael's Medical Center, Newark, NJ
- 7Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Germany
- 8Knight Cardiovascular Institute, Oregon Health and Science University, Portland, OR
Percutaneous Coronary Intervention (PCI) is one of the main stay treatments for symptomatic coronary artery disease. While drug-eluting stents (DES) constitute a majority of implants, bare-metal stents (BMS) remain important for a subset of patients with contraindications to longer duration of dual antiplatelet therapy (DAPT). Newer generation BMS offer advantages over older devices due to improved stent geometry and design, and decreased strut thickness.
The BIOHELIX-I study was a prospective, multicenter, non-randomized, single arm clinical trial designed to evaluate the safety and efficacy of the PRO-Kinetic Energy (PKE) Cobalt Chromium Coronary Stent System (BIOTRONIK AG, Switzerland). Thirty-three study centers (US, Columbia, Europe) enrolled 329 patients for treatment of one target lesion (≤ 31 mm). Eligible patients received a PRO-Kinetic Energy stent(s), at least one month of dual antiplatelet therapy and 36-months of follow-up. The primary endpoint was the 9-month rate of target vessel failure (TVF) which was compared with a pre-specified performance goal of 18.7% derived from prior BMS trials.
The mean age of patients in the BIOHELIX-I study was 69 years, of which 28.6% had diabetes. 329 target lesions were treated, of which 99.4% were de novo (mean lesion length 13.7 ± 6.0 mm). The 9-month TVF rate was 9.06% (p<0.001) and met the primary endpoint. The TVF component rates were 0.95% cardiac death, 1.58% myocardial infarction, and 7.26% ischemia-driven TVR. The ischemia-driven target lesion revascularization (TLR) rate at 9-months was 6.62%.
The 9-month TVF rate of the PRO-Kinetic Energy Cobalt Chromium Coronary Stent System was comparable to other bare metal stents and is a viable option for treating coronary artery disease. The low observed rate of ischemia-driven TVR supports the safety and efficacy of the novel BMS design.