Head-to-head comparison of the neointimal response between metallic and bioresorbable everolimus-eluting scaffolds using optical coherence tomography.

This study sought to compare the neointimal response of metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) by optical coherence tomography at 1 year. DES decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. BVS may overcome the risk of stent/scaffold thrombosis when completely resorbed. It is unknown if, during the bioresorption process, the neointimal response of the everolimus BVS (Absorb, Abbott Vascular, Santa Clara, California) differs from that of the metallic everolimus DES (Xience, Abbott Vascular). A total of 19 lesions were treated with a single everolimus DES, and 31 lesions were treated with everolimus BVS and imaged with optical coherence tomography at 1 year. Neointimal response was assessed as percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. At 1 year, no significant differences in the angiographic lumen loss were seen for the everolimus DES and everolimus BVS (0.18 ± 0.20 mm vs. 0.29 ± 0.36 mm; p = 0.42). optical coherence tomography analysis of 951 cross sections and 8,385 struts demonstrated similar rates of uncovered struts (5.3% everolimus DES vs. 4.5% everolimus BVS; p = 0.11), mean neointimal thickness (120.6 ± 46.0 μm vs. 136.1 ± 71.4 μm; p = 0.82) and in-stent/scaffold area obstruction (12.5 ± 7.1% vs. 13.6 ± 9.7%; p = 0.91), respectively. There was a trend of higher heterogenic tissue pattern of neointima (21.1% vs. 6.5%; p = 0.12) and less intraluminal masses (0% vs. 12.9%; p = 0.10) with everolimus DES than with everolimus BVS. The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.

Gomez-Lara J ，Brugaletta S ，Farooq V ，Onuma Y ，Diletti R ，Windecker S ，Thuesen L ，McClean D ，Koolen J ，Whitbourn R ，Dudek D ，Smits PC ，Chevalier B ，Regar E ，Veldhof S ，Rapoza R ，Ormiston JA ，Garcia-Garcia HM ，Serruys PW ... -  《-》

Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (

This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months. Fully bioresorbable scaffolds are a novel approach to treatment for coronary narrowing that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. However, a potential drawback of the bioresorbable scaffold is the potential for disruption of the strut network when overexpanded. Conversely, the structural discontinuity of the polymeric struts at a late stage is a biologically programmed fate of the scaffold during the course of bioresorption. The ABSORB cohort B trial is a multicenter single-arm trial assessing the safety and performance of the Absorb BVS in the treatment of 101 patients with de novo native coronary artery lesions. The current analysis included 51 patients with 143 OCT pullbacks who underwent OCT at baseline and follow-up. The presence of acute disruption or late discontinuities was diagnosed by the presence on OCT of stacked, overhung struts or isolated intraluminal struts disconnected from the expected circularity of the device. Of 51 patients with OCT imaging post-procedure, acute scaffold disruption was observed in 2 patients (3.9%), which could be related to overexpansion of the scaffold at the time of implantation. One patient had a target lesion revascularization that was presumably related to the disruption. Of 49 patients without acute disruption, late discontinuities were observed in 21 patients. There were no major adverse cardiac events associated with this finding except for 1 patient who had a non-ischemia-driven target lesion revascularization. Acute scaffold disruption is a rare iatrogenic phenomenon that has been anecdotally associated with anginal symptoms, whereas late strut discontinuity is observed in approximately 40% of patients and could be viewed as a serendipitous OCT finding of a normal bioresorption process without clinical implications. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

Onuma Y ，Serruys PW ，Muramatsu T ，Nakatani S ，van Geuns RJ ，de Bruyne B ，Dudek D ，Christiansen E ，Smits PC ，Chevalier B ，McClean D ，Koolen J ，Windecker S ，Whitbourn R ，Meredith I ，Garcia-Garcia HM ，Veldhof S ，Rapoza R ，Ormiston JA ... -  《-》

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

In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) 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. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB 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+DEB 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. 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+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. http://www.clinicaltrials.gov. Unique identifier: NCT01056744.

Poerner TC ，Otto S ，Gassdorf J ，Nitsche K ，Janiak F ，Scheller B ，Goebel B ，Jung C ，Figulla HR ... -  《-》

A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclita

Poerner TC ，Otto S ，Gassdorf J ，Janiak F ，Danzer C ，Ferrari M ，Figulla HR ... -  《-》

One-year head to head comparison of the neointimal response between sirolimus eluting stent with reservoir technology and everolimus eluting stent: an optical coherence tomography study.

to compare the vascular healing process between the sirolimus-eluting NEVO and the everolimus-eluting Xience stent by optical coherence tomography (OCT) at 1-year follow-up. Presence of durable polymer on a drug-eluting metallic stent may be the basis of an inflammatory reaction with abnormal healing response. The NEVO stent, having a bioresorbable polymer eluted by reservoir technology, may overcome this problem. All consecutive patients, who received NEVO or Xience stent implantation between September 2010 and October 2010 in our institution, were included. Vascular healing was assessed at 1-year as percentage of uncovered struts, neointimal thickness (NIT), in-stent/stent area obstruction and pattern of neointima. A total 47 patients (2:1 randomization, n = 32 NEVO, n = 15 Xience) were included. Eighteen patients underwent angiographic follow-up (eight patients with nine lesions for NEVO vs. 10 patients with 11 lesions for Xience). The angiographic late loss was numerically higher but not statistically different in NEVO compared with Xience treated lesions (0.38 ± 0.47 mm vs. 0.18 ± 0.27 mm; P = 0.171). OCT analysis of 4,912 struts demonstrated similar rates of uncovered struts (0.5 vs. 0.7%, P = 0.462), higher mean NIT (177.76 ± 87.76 µm vs. 132.22 ± 30.91 µm; P = 0.170) and in stent/stent area obstruction (23.02 ± 14.74% vs. 14.17 ± 5.94%, P = 0.120) in the NEVO as compared with Xience. The NEVO stent with a reservoir technology seems to exhibit more neointimal proliferation as compared to Xience stent. The findings of our study, which currently represent the unique data existing on this reservoir technology, would need to be confirmed in a large population.

Shiratori Y ，Brugaletta S ，Alvarez-Contreras L ，Azpeitia Y ，Ospino N ，Gaido S ，Delahanty A ，Santos A ，Martin-Yuste V ，Masotti M ，Serruys PW ，Windecker S ，Sabaté M ... -  《-》