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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

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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.

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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

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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.

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Correspondence to Francesco Burzotta.

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Burzotta, F., Brancati, M.F., Trani, C. et al. 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. Heart Vessels 31, 677–686 (2016). https://doi.org/10.1007/s00380-015-0671-3

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