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Bioresorbable vascular scaffold overlap evaluation with optical coherence tomography after implantation with or without enhanced stent visualization system (WOLFIE study): a two-centre prospective comparison

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Abstract

To assess if enhanced stent visualization (ESV)-guided implantation of overlapping bioresorbable vascular scaffold (BVS) is superior to angiography alone-guided implantation in the reduction of overlap length. WOLFIE is a two-centre prospective open study enrolling 30 patients treated with implantation of at least two overlapping BVS. In the first centre (London), BVS implantation was guided by conventional angiography, while in the second centre (Ferrara), an ESV system was systematically employed. The primary endpoint of the study was overlap length. Secondary endpoints were: stacked struts number, area, thickness, and amount of clusters. In the ESV-guided group, overlap length was significantly lower compared to angiography-guided group [0.9 (0.6–1.8) vs. 2.2 (1.3–3.2) mm, p = 0.02]. Similarly, all secondary endpoints were significantly reduced. ESV-guided implantation of overlapping BVS is safe and effective in minimizing both overlap length and number of stacked struts.

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Abbreviations

BVS:

Bioresorbable vascular scaffold

OCT:

Optical coherence tomography

ESV:

Enhanced stent visualization

NSTE-ACS:

Non ST elevated-acute coronary syndrome

PCI:

Percutaneous coronary intervention

DAPT:

Double antiplatelet therapy

QCA:

Quantitative coronary angiography

DES:

Drug eluting stent

TLF:

Target lesion failure

TVF:

Target vessel failure

TVR:

Target vessel revascularization

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Authors and Affiliations

  1. Cardiovascular Institute, Azienda Ospedaliera Universitaria S.Anna, Via Aldo Moro 8, Cona, Ferrara, FE, Italy

    Simone Biscaglia, Gianluca Campo, Matteo Tebaldi, Carlo Tumscitz, Rita Pavasini, Luca Fileti & Roberto Ferrari

  2. LTTA Centre, Ferrara, Italy

    Gianluca Campo & Roberto Ferrari

  3. Interventional Cardiology, Santi Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy

    Gioel G. Secco

  4. NIHR Cardiovascular Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK

    Gioel G. Secco & Carlo Di Mario

  5. Maria Cecilia Hospital, GVM Care & Research, E.S.: Health Science Foundation, Cotignola, Italy

    Roberto Ferrari

Authors
  1. Simone Biscaglia
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  2. Gianluca Campo
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  3. Matteo Tebaldi
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  4. Carlo Tumscitz
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  5. Rita Pavasini
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  6. Luca Fileti
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  7. Gioel G. Secco
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  8. Carlo Di Mario
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  9. Roberto Ferrari
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Corresponding author

Correspondence to Simone Biscaglia.

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Conflict of interest

The authors report no relationships that could be construed as a conflict of interest.

Ethical approval

All procedures were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The protocol was approved by the ethics committee at the two participating institutions, and enrolled patients gave written informed consent before inclusion.

Appendix

Appendix

See Tables 3, 4 and Fig. 4.

Table 3 Definitions of optical coherence tomography parameters used in the study
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Table 4 Reproducibility numbers for all measured endpoints
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Fig. 4
figure 4

Illustrations of the varying appearances of the stacked BVS struts at OCT imaging. BVS: bioresorbable vascular scaffold

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Biscaglia, S., Campo, G., Tebaldi, M. et al. Bioresorbable vascular scaffold overlap evaluation with optical coherence tomography after implantation with or without enhanced stent visualization system (WOLFIE study): a two-centre prospective comparison. Int J Cardiovasc Imaging 32, 211–223 (2016). https://doi.org/10.1007/s10554-015-0756-1

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  • DOI: https://doi.org/10.1007/s10554-015-0756-1

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