Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial

Abstract

AimsTo compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an ‘all-comers' population of patients, in order to clarify the mechanism of eventual differences in the biocompatibility and thrombogenicity of the devices.Methods and resultsPatients randomized to angiographic follow-up in the RESOLUTE All Comers trial (NCT00617084) at pre-specified OCT sites underwent OCT follow-up at 13 months. Tissue coverage and apposition were assessed strut by strut, and the results in both treatment groups were compared using multilevel logistic or linear regression, as appropriate, with clustering at three different levels: patient, lesion, and stent. Fifty-eight patients (30 ZES and 28 EES), 72 lesions, 107 stents, and 23 197 struts were analysed. Eight hundred and eighty-seven and 654 uncovered struts (7.4 and 5.8%, P= 0.378), and 216 and 161 malapposed struts (1.8 and 1.4%, P= 0.569) were found in the ZES and EES groups, respectively. The mean thickness of coverage was 116 ± 99 µm in ZES and 142 ± 113 µm in EES (P= 0.466). No differences in per cent neointimal volume obstruction (12.5 ± 7.9 vs. 15.0 ± 10.7%) or other areas–volumetric parameters were found between ZES and EES, respectively.ConclusionNo significant differences in tissue coverage, malapposition, or lumen/stent areas and volumes were detected by OCT between the hydrophilic polymer-coated ZES and the fluoropolymer-coated EES at 13-month follow-up.

Favorable Vessel Healing After Nobori Biolimus A9-Eluting Stent Implantation

“…The elution period for BES is 6-9 months, which is longer than for EES or SES. 32 In a recent study, the neointimal thickness was 80 µm in EES at 6 months 24 which is as good with in-stent thrombi was 3.96%, 0.5% and 7.0%, respectively. BES had stabilized in the 6-month OCT findings.…”

“…Moreover, another study revealed that the mean thickness of coverage was 142 µm at 13 months after EES implantation. 32 Furthermore, we reported that the average neointimal thickness with EES was 72 µm at 6 months and 126 µm at 12 months. 34 Neointimal growth from 6 to 12 months after implantation with EES was greater than that with BES.…”

Safety and Efficacy of Resolute Zotarolimus-Eluting Stents Compared With Everolimus-Eluting Stents

“…30 Along this line, optical coherence tomographic studies found no significant differences between R-ZES and EES in terms of tissue coverage, malapposition, and neointimal thickness throughout different follow-up periods. [31][32][33] In fact, favorable outcomes related to premature discontinuation of dual-antiplatelet therapy have been reported with both R-ZES and EES. 34,35 The consistency between findings from preclinical investigations, intracoronary imaging studies, and clinical trials further supports the equivalent safety and efficacy profile of R-ZES and EES.…”

Temporal Evolution of Strut Light Intensity After Implantation of Bioresorbable Polymeric Intracoronary Scaffolds in the ABSORB Cohort B Trial

“…This strut level matching was further confirmed by using a 3-D foldout view of the scaffold (Figures 2C-E). [13][14][15][16] In every cross-section with at least 1 scaffold strut, the lumen contour was drawn, and the strut angle was defined as the angle created by 2 lines originating from the center of the gravity of the lumen to the edges of the struts, taking the position at 3 o'clock as the 0° angle of reference (Figure 2A). 13 By correlating the cross-sectional angular position of the struts with the longitudinal distance of each strut from the distal edge of the .…”