title: The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Cardiology, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany; Deutsches Zentrum für Herz- und Kreislaufforschung (DZHK), Berlin, Germany; First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.
authors.forename: Milosz
authors.initials: M
authors.lastname: Jaguszewski
authors.affiliation: Cardiovascular Imaging Core Laboratory, Harrington Heart & Vascular Institute, Cleveland, Ohio.
authors.forename: Romila
authors.initials: R
authors.lastname: Aloysius
authors.affiliation: Cardiovascular Imaging Core Laboratory, Harrington Heart & Vascular Institute, Cleveland, Ohio.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Cardiovascular Imaging Department, Case Western Reserve University, Cleveland, Ohio.
authors.forename: Hiram G
authors.initials: HG
authors.lastname: Bezerra
authors.affiliation: Cardiovascular Division, King's College London, London, United Kingdom.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Hill
authors.affiliation: Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: De Winter
authors.affiliation: Heart Center, Satakunta Central Hospital, Pori, Finland.
authors.forename: Pasi P
authors.initials: PP
authors.lastname: Karjalainen
authors.affiliation: Antwerp Cardiovascular Institute, Middelheim Hospital, Antwerp, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.affiliation: Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Department of Cardiology, University Heart Center, University Hospital Zürich, Zürich, Switzerland.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.affiliation: CVPath Institute Inc., Gaithersburg, Maryland.
authors.forename: Michael
authors.initials: M
authors.lastname: Joner
authors.affiliation: Cardiovascular Imaging Department, Case Western Reserve University, Cleveland, Ohio.
authors.forename: Marco
authors.initials: M
authors.lastname: Costa
authors.affiliation: Department of Cardiology, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany; Deutsches Zentrum für Herz- und Kreislaufforschung (DZHK), Berlin, Germany. Electronic address: ulf.landmesser@charite.de.
authors.forename: Ulf
authors.initials: U
authors.lastname: Landmesser
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000276:immunology / Q000628:therapy*; D000368:Aged; D000906:Antibodies / Q000276:immunology*; D018952:Antigens, CD34 / Q000276:immunology*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002858:Chromium Alloys; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000276:immunology; D054855:Drug-Eluting Stents; D042783:Endothelial Cells / Q000276:immunology; D005060:Europe; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014481:United States; D014945:Wound Healing
chemical_list: D000906:Antibodies; D018952:Antigens, CD34; D002317:Cardiovascular Agents; D002858:Chromium Alloys; D000068338:Everolimus; D020123:Sirolimus
keywords: COMBO stent; OCT; early vascular healing response; neointimal hyperplasia