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

• Published in: Heart and vessels 2016-05, Vol.31 (5), p.677-686
• Main Authors: Burzotta, Francesco, Brancati, Marta Francesca, Trani, Carlo, Pirozzolo, Giancarlo, De Maria, Gianluigi, Leone, Antonio Maria, Niccoli, Giampaolo, Porto, Italo, Prati, Francesco, Crea, Filippo
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Biomedical Engineering and Bioengineering; Cardiac Catheters; Cardiac Surgery; Cardiology; Cardiovascular Agents - administration & dosage; Cardiovascular disease; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - therapy; Female; Humans; Hyperplasia; Male; Medicine; Medicine & Public Health; Metals; Middle Aged; Neointima; Original Article; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Prospective Studies; Risk Factors; Rome; Side effects; Stents; Time Factors; Tomography; Tomography, Optical Coherence; Treatment Outcome; Vascular Surgery
• ISSN: 0910-8327; 1615-2573
• DOI: 10.1007/s00380-015-0671-3

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