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Everolimus-Eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy: the CART (Cardiac Allograft Reparative Therapy) Prospective Multicenter Pilot Study

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Abstract

Cardiac allograft vasculopathy (CAV) is a form of accelerated atherosclerosis, which represents the leading cause of late morbidity and mortality after heart transplantation. The recent bioresorbable vascular scaffold (BVS) technology represents a potential novel therapeutic tool, in the context of CAV, by allowing transient scaffolding and concomitant vessel healing. Eligible subjects will be treated by using the Absorb Everolimus-Eluting BVS (Abbott Vascular, Santa Clara, CA, USA), and evaluated at pre-determined time points, up to 3 years since the index procedure. Both clinical and imaging data will be collected in dedicated case report forms (CRF). All imaging data will be analyzed in an independent core laboratory. The primary aim of the study is to evaluate the angiographic performance at 1 year of second-generation Absorb BVS, in heart transplant recipients affected by CAV.

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Abbreviations

BVS:

Bioresorbable vascular scaffold

CAD:

Coronary artery disease

CAV:

Cardiac allograft vasculopathy

CCS:

Canadian Cardiovascular Society Grading Score

CRF:

Case report form

DS:

Diameter stenosis

TLR:

Target lesion revascularization

EEM:

External elastic membrane

FU:

Follow-up

HTx:

Heart transplant

ISHLT:

International Society for Heart & Lung Transplantation

IVUS:

Intravascular ultrasound

IVUS-VH:

Intravascular ultrasound-virtual histology

MI:

Myocardial infarction

MLD:

Minimal lumen diameter

NTVR:

Non-target vessel revascularization

OCT:

Optical coherence tomography

PCI:

Percutaneous coronary intervention

PDLLA:

Poly-d,l-lactide acid

PLLA:

Poly-l-lactic acid

RVD:

Reference vessel diameter

QCA:

Quantitative coronary angiography

QMI:

Q wave myocardial infarction

TVR:

Target vessel revascularization

VRT:

Vascular reparative therapy

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Author information

Authors and Affiliations

  1. Department of Medicine, University of Verona, Piazzale Aristide Stefani n 1, 37126, Verona, Italy

    Michele Pighi, Corrado Vassanelli & Flavio Ribichini

  2. Department of Cardiovascular Sciences, European Hospital, Via Portuense, 700, 00149, Rome, Italy

    Fabrizio Tomai, Alessandro Petrolini & Leonardo de Luca

  3. Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, Padua, Italy

    Giuseppe Tarantini & Alberto Barioli

  4. Department of Cardiology and Cardiac Surgery, A. De Gasperis Niguarda Ca’ Granda Hospital, Milan, Italy

    Paola Colombo & Silvio Klugmann

  5. Department of Cardiovascular Sciences, IRCCS Foundation, Policlinico San Matteo, Pavia, Italy

    Marco Ferlini & Maurizio Ferrario Ormezzano

  6. Department of Cardiovascular Sciences, Brotzu Hospital, Cagliari, Italy

    Bruno Loi

  7. Cardio-thoracic and Respiratory Sciences Department, Second University of Naples, Monaldi Hospital, A.O.R.N. dei Colli, Naples, Italy

    Paolo Calabrò & Renato Maria Bianchi

  8. Department of Cardiac Surgery, University of Verona, Piazzale Aristide Stefani n 1, 37126, Verona, Italy

    Giuseppe Faggian & Alberto Forni

  9. Cardialysis, Rotterdam, The Netherlands

    Marco Valgimigli

Authors
  1. Michele Pighi
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  2. Fabrizio Tomai
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  3. Alessandro Petrolini
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  4. Leonardo de Luca
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  15. Alberto Forni
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  18. Flavio Ribichini
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Corresponding author

Correspondence to Michele Pighi.

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Conflict of Interest

The authors declare that they have no competing interests.

Ethical Approval

All procedures performed in studies involving human participants are 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.

Additional information

Associate Editor Emanuele Barbato oversaw the review of this article

Trial Registration

ClinicalTrials.gov registration number: NCT02377648 (24th February 2015)

URL: https://www.clinicaltrials.gov/ct2/show/NCT02377648

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Pighi, M., Tomai, F., Petrolini, A. et al. Everolimus-Eluting Bioresorbable Vascular Scaffold System in the Treatment of Cardiac Allograft Vasculopathy: the CART (Cardiac Allograft Reparative Therapy) Prospective Multicenter Pilot Study. J. of Cardiovasc. Trans. Res. 9, 40–48 (2016). https://doi.org/10.1007/s12265-015-9665-x

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  • DOI: https://doi.org/10.1007/s12265-015-9665-x

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