Nine-month results of the BIOHELIX-I clinical trial study: Evaluation of the PRO-Kinetic Energy cobalt chromium bare-metal stent system. Other Scholarly Work

Michael, Tesfaldet T, Richardt, Gert, Lansky, Alexandra et al. (2018). Nine-month results of the BIOHELIX-I clinical trial study: Evaluation of the PRO-Kinetic Energy cobalt chromium bare-metal stent system. . 92(6), 1030-1039. 10.1002/ccd.27434

cited authors

  • Michael, Tesfaldet T; Richardt, Gert; Lansky, Alexandra; Carney, Robert J; Khan, Muhammad Akram; Shehadeh, Abbas; Zeymer, Uwe; Gupta, Saurabh

authors

abstract

  • 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.

publication date

  • November 1, 2018

keywords

  • Aged
  • Chromium Alloys
  • Coronary Artery Disease
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention
  • Prospective Studies
  • Prosthesis Design
  • Stents
  • Time Factors
  • Treatment Outcome

Digital Object Identifier (DOI)

Medium

  • Print-Electronic

start page

  • 1030

end page

  • 1039

volume

  • 92

issue

  • 6