Back to Search Start Over

The REMEDEE-OCT Study

The REMEDEE-OCT Study

Authors :
Jonathan Hill
Marco A. Costa
Thomas F. Lüscher
Romila Aloysius
Wei Wang
Pasi P. Karjalainen
Michael Joner
Hiram G. Bezerra
Miłosz Jaguszewski
Stefan Verheye
Robbert J. de Winter
Ulf Landmesser
William Wijns
Source :
JACC: Cardiovascular Interventions. 10:489-499
Publication Year :
2017
Publisher :
Elsevier BV, 2017.

Abstract

Objectives The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. Background CD34+ cells promote endothelial repair after vascular injury. The bioengineered COMBO Dual Therapy Stent combines CD34+ cell–capturing technology with abluminal sirolimus release, but more data from clinical studies evaluating the vascular response are needed. Methods In a prospective randomized multicenter clinical trial, 60 patients with acute coronary syndromes were randomized 1:1 to COMBO or CoCr EES implantation. The primary endpoint was the percentage of uncovered stent struts per stent. Stent assessment by optical coherence tomography was performed at baseline and at 60 days, followed by independent core laboratory analysis. Results The percentage of uncovered struts per stent was higher with the COMBO than the CoCr EES at 60 days (median 14.7% vs. 7.7%; p = 0.04). However, no significant difference in uncovered stent struts was observed in the strut level–based analysis at 60 days, which also accounted for clustering (COMBO vs. CoCr EES; 13.6% vs. 6.9%; p = 0.09; generalized linear mixed models–adjusted analysis). Neointimal thickness at 60 days was lower with the COMBO compared with the CoCr EES (median 30.17 vs. 50.26 μm; p = 0.02; stent-level analysis). There were no significant differences in the frequency of major adverse cardiac events and each component of major adverse cardiac events within the study population between the 2 groups at 30, 60, 180, 360, and 540 days post-procedure. No target vessel stent thrombosis has been documented within 540 days. Conclusions The present multicenter, prospective clinical study for the first time compared the vascular response of the bioengineered COMBO Dual Therapy Stent with a CoCr EES in patients early after acute coronary syndrome by using intracoronary optical coherence tomographic analysis. The percentage of uncovered stent struts per stent was somewhat higher after COMBO versus CoCr EES implantation as detected by optical coherence tomography, associated with reduced neointimal thickness.

Details

ISSN :
19368798
Volume :
10
Database :
OpenAIRE
Journal :
JACC: Cardiovascular Interventions
Accession number :
edsair.doi...........b4cad944eb7e4bf44be34ba614f83d4a
Full Text :
https://doi.org/10.1016/j.jcin.2016.11.040