title: 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.
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 mm(2) (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).
  
  
  BACKGROUND
  http://www.clinicaltrials.gov . Identifier: NCT01057563.
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy. f.burzotta@rm.unicatt.it.
authors: Francesco
authors: F
authors: Burzotta
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Marta Francesca
authors: MF
authors: Brancati
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Carlo
authors: C
authors: Trani
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Giancarlo
authors: G
authors: Pirozzolo
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Gianluigi
authors: G
authors: De Maria
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Antonio Maria
authors: AM
authors: Leone
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Giampaolo
authors: G
authors: Niccoli
authors: Cardiovascular Department, San Donato Hospital, Arezzo, Italy.
authors: Italo
authors: I
authors: Porto
authors: Department of Interventional Cardiology, San Giovanni Hospital, Rome, Italy.
authors: Francesco
authors: F
authors: Prati
authors: Institute of Cardiology, Catholic University of the Sacred Heart, L.Go Gemelli 1, 00168, Rome, Italy.
authors: Filippo
authors: F
authors: Crea
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008670:Metals; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation*; D011446:Prospective Studies; D012307:Risk Factors; D012384:Rome; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals
keywords: Bare-metal stent; Drug-eluting balloon; Neointima; Optical coherence tomography