BACKGROUND: In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the @entity1311 drug-eluting balloon ( @entity16905 ) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. METHODS AND RESULTS: A total of 105 lesions in 90 @entity1 were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please @entity16905 (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64  9.65% in BMS+ @entity16905 versus 4.93  9.29% in DES; P=0.366) were found. Thus, BMS+ @entity16905 achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+ @entity16905 group (15.7  7.8 versus 11.0  5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8  11.9 versus 16.9  10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5  13.8% versus 36.8  15.6%; P=0.409) was found. CONCLUSIONS: Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+ @entity16905 effectively prevented clinically relevant focal restenosis at 6-month follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01056744.

Stent coverage and neointimal proliferation in bare metal stents postdilated with a XXXX -eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity16905 :: ('CHEBI:23704', 'Chemical') :: ['DEB']
@entity1311 :: (MESH:D017239,Chemical) :: ['Paclitaxel']
