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Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry

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Abstract

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34+ antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

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Abbreviations

DES:

Drug-eluting stent

BMS:

Bare metal stent

ST:

Stent thrombosis

DAPT:

Dual anti-platelet therapy

PCI:

Percutaneous coronary intervention

NICE:

National Institute for Clinical Excellence

ECS:

Endothelial progenitor cell capturing stent

EPC:

Endothelial progenitor cells

HEALING:

Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth registry

MI:

Myocardial infarction

TVF:

Target vessel failure

TVR:

Target vessel revascularization

TLR:

Target lesion revascularization

CEC:

Clinical Event Committee

IRD:

Insulin requiring diabetic

NIRD:

Non-insulin requiring diabetic

CABG:

Coronary artery bypass grafting

PES:

Paclitaxel-eluting stent

SES:

Sirolimus-eluting stent

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Acknowledgments

We thank all centers and investigators participating in the e-HEALING registry. Most importantly, we thank all participating patients.

Conflict of interest

The Academic Medical Center received unrestricted research grant support from OrbusNeich Medical BV. The e-HEALING Registry was funded by OrbusNeich Medical BV, The Netherlands.

Author information

Authors and Affiliations

  1. Department of Cardiology, Cardiac Catheterization Laboratory, B2-137 Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands

    Margo Klomp, Peter Damman, Marcel A. M. Beijk, Jan G. P. Tijssen & Robbert J. de Winter

  2. Kardiologische Praxis und Praxisklinik, Munich, Germany

    Sigmund Silber

  3. Klinische Abteilung fur Kardiologie, Medizinische Universitatsklinik, Graz, Austria

    Manfred Grisold

  4. Incor, The Heart Institute of the University of São Paulo, São Paulo, Brazil

    Expedito E. Ribeiro

  5. Isala Klinieken, Hospital De Weezenlanden, Zwolle, The Netherlands

    Harry Suryapranata

  6. Department of Cardiology, Medical University of Lublin, Lublin, Poland

    Jaroslaw Wòjcik

  7. Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, Kuching, Sarawak, Malaysia

    Kui Hian Sim

Authors
  1. Margo Klomp
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  2. Peter Damman
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  3. Marcel A. M. Beijk
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  4. Sigmund Silber
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  5. Manfred Grisold
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  6. Expedito E. Ribeiro
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  7. Harry Suryapranata
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  8. Jaroslaw Wòjcik
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  9. Kui Hian Sim
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  10. Jan G. P. Tijssen
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  11. Robbert J. de Winter
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Corresponding author

Correspondence to Robbert J. de Winter.

Additional information

On behalf of the e-HEALING investigators.

M. Klomp, P. Damman, and M. A. M. Beijk contributed equally.

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Klomp, M., Damman, P., Beijk, M.A.M. et al. Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry. Heart Vessels 27, 360–369 (2012). https://doi.org/10.1007/s00380-011-0167-8

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