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Nine‐month results of the BIOHELIX‐I clinical trial study: Evaluation of the PRO‐Kinetic Energy cobalt chromium bare‐metal stent system
Author(s) -
Michael Tesfaldet T.,
Richardt Gert,
Lansky Alexandra,
Carney Robert J.,
Khan Muhammad Akram,
Shehadeh Abbas,
Zeymer Uwe,
Gupta Saurabh
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27434
Subject(s) - medicine , percutaneous coronary intervention , stent , clinical endpoint , target lesion , bare metal stent , cardiology , revascularization , coronary artery disease , myocardial infarction , bare metal , clinical trial , surgery , drug eluting stent , restenosis
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.