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Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART)

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Abstract

Background

Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of failure.

Objective

This study aimed to investigate the safety and efficacy of bioresorbable scaffolds (BRSs) as potential novel therapeutic tool for the treatment of coronary stenoses in CAV.

Methods

This is a multicenter, single-arm, prospective, open-label study (CART, NCT02377648), that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS (Abbott Vascular). The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the incidence of major adverse cardiac events (MACEs) at 12- and 36-month follow-up and the incidence of ISSR at 36 months. A paired intracoronary imaging analysis at baseline and follow-up was also performed.

Results

Between 2015 and 2017 35 HTx patients were enrolled and treated for 44 coronary lesions with 51 BRSs. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37). Angiographic lumen loss was 0.40 ± 0.62 mm at 12 months and 0.53 ± 0.57 mm at 36 months. Overall survival rate was 91.4% and 74.3%, and MACEs incidence 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis, a significant increase of the vessel external elastic membrane area in the treated segment and some progression of CAV proximally to the BRS were detected.

Conclusions

BRS-based PCI for the treatment of CAV is feasible and safe, with an ISSR incidence similar to what reported in retrospective studies with drug-eluting stents.

Graphical abstract

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Data availability

The data that support the findings of this study are available from the corresponding author on reasonable request.

Abbreviations

BRS:

Bioresorbable scaffold

CAV:

Cardiac allograft vasculopathy

DCB:

Drug-coated balloon

DES:

Drug-eluting stent

EEM:

External elastic membrane

HTx:

Heart transplantation

ISA:

Incomplete stent apposition

ISHLT:

International society of heart and lung transplantation

ISR:

In-stent restenosis

ISSR:

In-segment scaffold restenosis

IVUS:

Intravascular ultrasound

MACE:

Major adverse cardiac events

MSA:

Minimal stent area

OCT:

Optical coherence tomography

QCA:

Quantitative coronary artery

PCI:

Percutaneous coronary interventions

TLR:

Target lesion revascularization

VH:

Virtual histology

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Funding

This study was partially funded by an unrestricted research grant by Abbott Vascular Italy.

Author information

Authors and Affiliations

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

    Michele Pighi, Simone Fezzi, Gabriele Pesarini, Valeria Ferrero & Flavio Ribichini

  2. Department of Cardiovascular Sciences, European Hospital, Rome, Italy

    Fabrizio Tomai & Alessandro Petrolini

  3. Department of Cardiovascular Sciences, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy

    Leonardo Spedicato

  4. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy

    Giuseppe Tarantini

  5. Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    Marco Ferlini

  6. Department of Translational Medical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy

    Paolo Calabrò

  7. Division of Clinical Cardiology, Sant’Anna e San Sebastiano Hospital, Caserta, Italy

    Paolo Calabrò

  8. Division of Cardiology, Azienda Ospedaliera Brotzu, Cagliari, Italy

    Bruno Loi

  9. Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands

    Maria Natalia Tovar Forero & Joost Daemen

Authors
  1. Michele Pighi
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  2. Fabrizio Tomai
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  11. Valeria Ferrero
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  14. Flavio Ribichini
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Contributions

FR, MP, and FT: conceived and design the study; SF, MP, MTF, JD, and FR: performed the analyses and the interpretation of data; SF, MP, and FR: drafted the work; MP, SF, FR, FT, GT, MF, BL, LS, and JD: revised the work critically for important intellectual content; all the authors provided their final approval of the version to be published and the agreement to be accountable for all aspects of the work.

Corresponding author

Correspondence to Gabriele Pesarini.

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Conflict of interest

JD received institutional grant/research support from Astra Zeneca, Abbott Vascular, Boston Scientific, ACIST Medical, Medtronic, Microport, Pie Medical, and ReCor medical. All the other authors report no relevant conflicts of interest.

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Pighi, M., Tomai, F., Fezzi, S. et al. Safety and efficacy of everolimus-eluting bioresorbable vascular scaffold for cardiac allograft vasculopathy (CART). Clin Res Cardiol (2024). https://doi.org/10.1007/s00392-023-02351-9

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  • DOI: https://doi.org/10.1007/s00392-023-02351-9

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