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Heart and Vessels

, Volume 31, Issue 5, pp 677–686 | Cite as

Impact of drug-eluting balloon (pre- or post-) dilation on neointima formation in de novo lesions treated by bare-metal stent: the IN-PACT CORO trial

  • Francesco Burzotta
  • Marta Francesca Brancati
  • Carlo Trani
  • Giancarlo Pirozzolo
  • Gianluigi De Maria
  • Antonio Maria Leone
  • Giampaolo Niccoli
  • Italo Porto
  • Francesco Prati
  • Filippo Crea
Original Article

Abstract

The efficacy of DEB in modifying the high restenosis risk associated with BMS implantation is doubtful. Optical coherence tomography (OCT) may allow precise assessment of neointimal formation after stent implantation. We performed a single-center, prospective, 1:2 randomized trial comparing BMS implantation alone (BMS group) vs. additional DEB (DEB group). DEB patients were further randomized 1:1 to DEB before stenting (pre-DEB group), or after stenting (post-DEB group). Primary endpoint was OCT-assessed neointimal hyperplasia (expressed both as mean in-stent neointimal area and as percentage obstruction of the mean stent area) at 6 months. Secondary endpoints were the percentage of uncovered and malapposed stent struts. Thirty patients were enrolled and randomized to BMS (n = 10), pre-DEB (n = 10), post-DEB (n = 10). At 6-month OCT follow-up, DEB significantly reduced neointimal area compared with BMS: mean neointimal area 2.01 ± 0.89 vs. 3.03 ± 1.07 mm2 (p = 0.02), percentage area obstruction 24.56 ± 12.50 vs. 37.51 ± 12.26 % (p = 0.02). The percentage of uncovered and malapposed stent struts did not differ significantly between BMS and DEB. In the comparison between pre-DEB and post-DEB, no significant difference was observed for both primary and secondary endpoints. In de novo coronary lesions treated with BMS, DEB use could be associated with a mild reduction in neointimal hyperplasia at 6 months; this effect could be unrelated to the timing of DEB dilation (pre- or post-stenting).

Clinical Trial Registration Information: http://www.clinicaltrials.gov. Identifier: NCT01057563.

Keywords

Neointima Bare-metal stent Drug-eluting balloon Optical coherence tomography 

Abbreviations

BMS

Bare-metal stent

CTO

Chronic total occlusion

DEB

Drug-eluting balloon

DES

Drug-eluting stent

ISA

Incomplete strut apposition

ISR

In-stent restenosis

MACE

Major adverse cardiac event

OCT

Optical coherence tomography

PCI

Percutaneous coronary intervention

QCA

Quantitative coronary angiography

Notes

Acknowledgments

The authors wish to thank Dr. Giuseppe Ferrante for his valuable help during the study design phase (in particular for sample size estimation).

Conflict of interest

Francesco Burzotta reports to have been involved in advisory board meetings by Medtronic.

Supplementary material

380_2015_671_MOESM1_ESM.doc (38 kb)
Supplementary material 1 (DOC 38 kb)
380_2015_671_MOESM2_ESM.doc (40 kb)
Supplementary material 2 (DOC 40 kb)
380_2015_671_MOESM3_ESM.doc (34 kb)
Supplementary material 3 (DOC 34 kb)

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Copyright information

© Springer Japan 2015

Authors and Affiliations

  • Francesco Burzotta
    • 1
  • Marta Francesca Brancati
    • 1
  • Carlo Trani
    • 1
  • Giancarlo Pirozzolo
    • 1
  • Gianluigi De Maria
    • 1
  • Antonio Maria Leone
    • 1
  • Giampaolo Niccoli
    • 1
  • Italo Porto
    • 2
  • Francesco Prati
    • 3
  • Filippo Crea
    • 1
  1. 1.Institute of CardiologyCatholic University of the Sacred HeartRomeItaly
  2. 2.Cardiovascular DepartmentSan Donato HospitalArezzoItaly
  3. 3.Department of Interventional CardiologySan Giovanni HospitalRomeItaly

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