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 paclitaxel-eluting balloon (OCTOPUS Trial): rationale, design and methods

Poerner, Tudor C.; Otto, Sylvia; Gassdorf, Johannes; Janiak, Florian; Danzer, Constance; Ferrari, Markus; Figulla, Hans R

doi:10.4244/eijv7ska16

Cited by 12 publications

(6 citation statements)

References 26 publications

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“…The data presented in this manuscript are collected in a sub-study from the OCTOPUS trial. The design and results of the main study have already been published [21, 22]. Briefly, the trial was intended to randomly compare two interventional devices (Xience V™ drug-eluting stents vs. bare metal stents post-dilated with a paclitaxel-coated balloon) in patients with stable CAD.…”

Section: Methodsmentioning

confidence: 99%

Endothelial progenitor cells and plaque burden in stented coronary artery segments: an optical coherence tomography study six months after elective PCI

Otto

Nitsche

Jung³

et al. 2017

BMC Cardiovasc Disord

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BackgroundEndothelial progenitor cells (EPC) are involved in neovascularization and endothelial integrity. They might be protective in atherosclerosis. Optical coherence tomography (OCT) is a precise intracoronary imaging modality that allows assessment of subintimal plaque development. We evaluated the influence of EPC on coronary plaque burden in stable disease and implemented a novel computational plaque analysis algorithm using OCT.MethodsForty-three patients (69.8% males, 69.6 ± 7.7 years) were investigated by OCT during re-angiography 6 months after elective stent implantation. Different subpopulations of EPCs were identified by flow cytometry according to their co-expression of antigens (CD34+, CD133+, kinase domain receptor, KDR+). An algorithm was applied to calculate the underlying total plaque burden of the stented segments from OCT images. Plaque morphology was assessed according to international consensus in OCT imaging.ResultsA cumulative sub-strut plaque volume of 10.87 ± 12.7 mm3 and a sub-stent plaque area of 16.23 ± 17.0 mm2 were found within the stented vessel segments with no significant differences between different stent types. All EPC subpopulations (mean of EPC levels: CD34+/CD133+: 2.66 ± 2.0%; CD34+/KDR+: 7.50 ± 5.0%; CD34+/CD133+/KDR+: 1.12 ± 1.0%) inversely correlated with the identified underlying total plaque volume and plaque area (p ≤ 0.012).ConclusionsThis novel analysis algorithm allows for the first time comprehensive quantification of coronary plaque burden by OCT and illustration as spread out vessel charts. Increased EPC levels are associated with less sub-stent coronary plaque burden which adds to previous findings of their protective role in atherosclerosis.

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Section: Methodsmentioning

confidence: 99%

Endothelial progenitor cells and plaque burden in stented coronary artery segments: an optical coherence tomography study six months after elective PCI

Otto

Nitsche

Jung³

et al. 2017

BMC Cardiovasc Disord

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“…In bifurcation lesions the results are also promising (PEPCAD V, DEBUIT) even with BMS use, nevertheless BMS + DEB in the DEBUIT trial was not superior to BMS alone [11,12]. However, the results in trials comparing BMS + DEB and DES (PEPCAD III, OCTOPUS) in de novo coronary lesions were disappointing [13,14] except if it was a paclitaxel DES (PEPCAD IV, PEPCAD CTO, LOCAL TAX) [15][16][17]. Trials in acute coronary syndromes are rare.…”

Section: Discussionmentioning

confidence: 99%

Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

Bešić

Strozzi

Margetić

et al. 2015

Journal of Cardiology

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“…Stented vessel segments were extracted after 7 or 28 days and processed for post-mortem histological analysis. In three animals stent coverage was assessed in vivo using OCT (M2 CV system, LightLab Imaging Inc., Westford, MA, USA) for intravascular, high-resolution imaging as previously described [ 32 ].…”

Section: Methodsmentioning

confidence: 99%

A novel polymer-free ciglitazone-coated vascular stent: in vivo and ex vivo analysis of stent endothelialization in a rabbit iliac artery model

et al. 2016

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AimPeroxisome proliferator-activated receptor-gamma (PPARg) agonists have known pleiotropic cardiovascular effects with favourable properties in vascular remodeling, and specifically in suppression of vascular smooth muscle cell proliferation. A novel vascular stent coating using the PPARg ligand ciglitazone (CCS) was investigated regarding its effects on endothelialization after 7 and 28 days.MethodsMicroporous bare metal stents (BMS) were coated with ciglitazone by ultrasonic flux with a load of 255 μg ciglitazone/stent. SixteenNew Zealand white rabbits, fed a with high cholesterol diet, underwent stent implantation in both iliac arteries. Everolimus-eluting stents (EES) and BMS were comparators. Histology (CD 31 immunostaining, confocal and scanning electron microscopy, morphometry) was performed after 7 and 28 days and by OCT (optical coherence tomography) in vivo after 28 days.ResultsMicroscopy showed comparable results with near complete endothelialization in CCS and BMS (%CD31 above stent struts after 7 days: 67.92±36.35 vs. 84.48±23.86; p = 0.55; endothel % above stent struts: 77.22±27.9 vs. 83.89±27.91; p = 0.78). EES were less endothelialized with minimal fibrin deposition, not found in BMS and CCS (% CD 31 above struts after 28 days, BMS: 100.0±0.0 vs. EES: 95.9±3.57 vs. CCS: 100.0±0.0; p = 0.0292). OCT revealed no uncovered struts in all stents after 28 days.ConclusionsPolymer-free coating with ciglitazone, a PPARg agonist is feasible and stable over time. Our data prove unimpaired endothelial coverage of a ciglitazone-coated vascular stent system by histology and OCT. Thus, this PPARg agonist coating deserves further investigation to evaluate its potency on local neointimal suppression.

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Abstract: The study is currently on-going and its termination is scheduled for February 2010. (ClinicalTrials.gov identifier: NCT01056744).

Cited by 12 publications

References 26 publications

Endothelial progenitor cells and plaque burden in stented coronary artery segments: an optical coherence tomography study six months after elective PCI

Endothelial progenitor cells and plaque burden in stented coronary artery segments: an optical coherence tomography study six months after elective PCI

Drug-eluting balloons in patients with non-ST elevation acute coronary syndrome

A novel polymer-free ciglitazone-coated vascular stent: in vivo and ex vivo analysis of stent endothelialization in a rabbit iliac artery model

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