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

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

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
JournalCatheterization and Cardiovascular Interventions
DOIs
StateAccepted/In press - Jan 1 2017
Externally publishedYes

Fingerprint

Chromium
Cobalt
Stents
Metals
Clinical Trials
Ischemia
Safety
Coronary Artery Disease
Clinical Studies
Drug-Eluting Stents
Percutaneous Coronary Intervention
Switzerland
Therapeutics
Myocardial Infarction

Keywords

  • Angina
  • Bare-metal stent
  • Percutaneous coronary intervention
  • PRO-Kinetic Energy

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Nine-month results of the BIOHELIX-I clinical trial study : Evaluation of the PRO-Kinetic Energy cobalt chromium bare-metal stent system. / Michael, Tesfaldet T.; Richardt, Gert; Lansky, Alexandra; Carney, Robert J.; Khan, Muhammad Akram; Shehadeh, Abbas; Zeymer, Uwe; Gupta, Saurabh.

In: Catheterization and Cardiovascular Interventions, 01.01.2017.

Research output: Contribution to journalArticle

Michael, Tesfaldet T. ; Richardt, Gert ; Lansky, Alexandra ; Carney, Robert J. ; Khan, Muhammad Akram ; Shehadeh, Abbas ; Zeymer, Uwe ; Gupta, Saurabh. / Nine-month results of the BIOHELIX-I clinical trial study : Evaluation of the PRO-Kinetic Energy cobalt chromium bare-metal stent system. In: Catheterization and Cardiovascular Interventions. 2017.
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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.",
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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

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Y1 - 2017/1/1

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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 - Angina

KW - Bare-metal stent

KW - Percutaneous coronary intervention

KW - PRO-Kinetic Energy

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