TY - JOUR
T1 - Nine-month results of the BIOHELIX-I clinical trial study
T2 - Evaluation of the PRO-Kinetic Energy cobalt chromium bare-metal stent system
AU - Michael, Tesfaldet T.
AU - Richardt, Gert
AU - Lansky, Alexandra
AU - Carney, Robert J.
AU - Khan, Muhammad Akram
AU - Shehadeh, Abbas
AU - Zeymer, Uwe
AU - Gupta, Saurabh
N1 - Publisher Copyright:
© 2017 Wiley Periodicals, Inc.
PY - 2018/11/15
Y1 - 2018/11/15
N2 - Objectives: To evaluate the safety and efficacy of the PRO-Kinetic Energy (PKE) Cobalt Chromium Coronary Stent System (BIOTRONIK AG, Switzerland). Background: Percutaneous coronary intervention is a mainstay treatment for symptomatic coronary artery disease (CAD). While drug-eluting stents constitute a majority of implants, bare-metal stents (BMS) remain important for a subset of patients. Newer generation BMS offer advantages due to stent design improvements. Methods: The BIOHELIX-I study was a prospective, multicenter, non-randomized, single arm clinical trial designed to evaluate the safety and efficacy of the PKE bare metal stent. Thirty-three study centers (US, Columbia, Europe) enrolled 329 patients for treatment of one target lesion (≤31 mm). Eligible patients received a PKE stent(s), at least one 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 prior BMS trials. Results: The mean patient age was 69 years, 28.6% with diabetes. The mean lesion length was 13.7 ± 6.0 mm. The 9-month TVF rate was 9.06% and met the primary endpoint (P < 0.001). 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%. Conclusions: The 9-month TVF rate of the PKE stent was comparable to other BMS and is a viable option for treating CAD. The low observed rate of ischemia-driven TVR supports the safety and efficacy of the novel BMS design.
AB - Objectives: To evaluate the safety and efficacy of the PRO-Kinetic Energy (PKE) Cobalt Chromium Coronary Stent System (BIOTRONIK AG, Switzerland). Background: Percutaneous coronary intervention is a mainstay treatment for symptomatic coronary artery disease (CAD). While drug-eluting stents constitute a majority of implants, bare-metal stents (BMS) remain important for a subset of patients. Newer generation BMS offer advantages due to stent design improvements. Methods: The BIOHELIX-I study was a prospective, multicenter, non-randomized, single arm clinical trial designed to evaluate the safety and efficacy of the PKE bare metal stent. Thirty-three study centers (US, Columbia, Europe) enrolled 329 patients for treatment of one target lesion (≤31 mm). Eligible patients received a PKE stent(s), at least one 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 prior BMS trials. Results: The mean patient age was 69 years, 28.6% with diabetes. The mean lesion length was 13.7 ± 6.0 mm. The 9-month TVF rate was 9.06% and met the primary endpoint (P < 0.001). 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%. Conclusions: The 9-month TVF rate of the PKE stent was comparable to other BMS and is a viable option for treating CAD. The low observed rate of ischemia-driven TVR supports the safety and efficacy of the novel BMS design.
KW - PRO-Kinetic Energy
KW - angina
KW - bare-metal stent
KW - percutaneous coronary intervention
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U2 - 10.1002/ccd.27434
DO - 10.1002/ccd.27434
M3 - Article
C2 - 29271575
AN - SCOPUS:85038832249
SN - 1522-1946
VL - 92
SP - 1030
EP - 1039
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 6
ER -