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, Carlo Trani, Filippo Crea, Marta Francesca Brancati, Antonio Maria Leone, Giampaolo Niccoli, Italo Porto, Francesco Prati

Risultato della ricerca: Contributo in rivistaArticolo in rivista

9 Citazioni (Scopus)

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.
Lingua originaleEnglish
pagine (da-a)677-686
Numero di pagine10
RivistaHeart and Vessels
Volume31
DOI
Stato di pubblicazionePubblicato - 2016

Keywords

  • Aged
  • Angioplasty, Balloon, Coronary
  • Bare-metal stent
  • Cardiac Catheters
  • Cardiology and Cardiovascular Medicine
  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Coronary Angiography
  • Coronary Artery Disease
  • Coronary Restenosis
  • Drug-eluting balloon
  • Female
  • Humans
  • Hyperplasia
  • Male
  • Metals
  • Middle Aged
  • Neointima
  • Optical coherence tomography
  • Percutaneous Coronary Intervention
  • Prospective Studies
  • Risk Factors
  • Rome
  • Stents
  • Time Factors
  • Tomography, Optical Coherence
  • Treatment Outcome

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