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The REMEDEE-OCT Study
The REMEDEE-OCT Study
- 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.
- Subjects :
- Neointimal hyperplasia
Acute coronary syndrome
medicine.medical_specialty
medicine.diagnostic_test
business.industry
medicine.medical_treatment
Stent
030204 cardiovascular system & hematology
equipment and supplies
medicine.disease
Dual therapy stent
03 medical and health sciences
surgical procedures, operative
0302 clinical medicine
Optical coherence tomography
Sirolimus
Coronary stent
medicine
Clinical endpoint
cardiovascular diseases
030212 general & internal medicine
Radiology
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
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