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REMEDEE-OCT: Percentage of uncovered stent struts higher with dual-therapy stent in ACS
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The percentage of uncovered struts per stent was higher after implantation with a bioengineered sirolimus-eluting stent that also employs CD34+ cell-capturing technology vs. a cobalt-chromium everolimus-eluting stent, according to published data.
“The Combo dual-therapy stent (OrbusNeich Medical) was designed to combine abluminal release of sirolimus from a bioresorbable polymer matrix with a CD34+ cell-capturing mechanism to obtain adequate suppression of neointimal proliferation and restenosis, while promoting endothelial repair,” the researchers wrote.
In the prospective, randomized, multicenter REMEDEE-OCT trial, 60 patients with ACS were randomly assigned to the Combo dual-therapy stent or the new-generation cobalt-chromium EES (Xience V, Abbott Vascular). OCT and quantitative comparative analysis were performed at baseline and 60-day follow-up, followed by an independent core laboratory analysis.
At 60 days, the median percentage of uncovered struts per stent was higher with the dual-therapy stent vs. the cobalt-chromium EES (14.7% vs. 7.7%; P = .04). There was no significant difference, however, in the strut level-based general linear mixed models-adjusted analysis, which accounted for clustering, at 60 days (13.6% vs. 6.9%; P = .09).
The researchers also observed lower median neointimal thickness at 60 days with the dual-therapy stent vs. the cobalt-chromium EES in the stent-level analysis (30.17 µm vs. 50.26 µm; P = .02).
According to the researchers, the frequency of MACE as well as its individual components did not differ significantly between the two groups, and the researchers found no cases of target vessel stent thrombosis during follow-up. MACE was defined as a composite of cardiac death, MI, emergent CABG, clinically justified target lesion revascularization by repeat PCI or CABG at hospital discharge and 30, 60, 180, 360 and 540 days after the procedure, and target vessel stent thrombosis at 30, 60, 180, 360 and 540 days after the procedure.
Despite the findings, the researchers wrote the study was not powered for clinical outcomes. Additionally, they highlighted the lack of significant difference between the groups in the strut-level analysis and noted that OCT imaging may not detect very thin neointima.
“A cautionary interpretation of the OCT findings is, therefore, currently advocated,” the researchers wrote. – by Melissa Foster
Disclosure: The study was funded by OrbusNeich Medical. Please see the full study for a list of the researchers’ relevant financial disclosures.
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