title: The REMEDEE trial: a randomized comparison of a combination sirolimus-eluting endothelial progenitor cell capture stent with a paclitaxel-eluting stent.
abstract: OBJECTIVE
  This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.
  
  
  BACKGROUND
  Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations.
  
  
  METHODS
  One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events.
  
  
  RESULTS
  The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group.
  
  
  CONCLUSIONS
  In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.
authors.affiliation: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. mhaude@lukasneuss.de
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Stephen W L
authors.initials: SW
authors.lastname: Lee
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Worthley
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Sandra
authors.initials: S
authors.lastname: Erbs
authors.forename: Mohd Ali
authors.initials: MA
authors.lastname: Rosli
authors.forename: Roberto
authors.initials: R
authors.lastname: Botelho
authors.forename: Ian
authors.initials: I
authors.lastname: Meredith
authors.forename: Kui Hian
authors.initials: KH
authors.lastname: Sim
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
authors.forename: Huay-Cheem
authors.initials: HC
authors.lastname: Tan
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.forename: Sukumaran
authors.initials: S
authors.lastname: Thambar
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Tian Hai
authors.initials: TH
authors.lastname: Koh
authors.forename: Peter
authors.initials: P
authors.lastname: Den Heijer
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Ecaterina
authors.initials: E
authors.lastname: Cristea
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D000368:Aged; D000906:Antibodies / Q000008:administration & dosage*; D018952:Antigens, CD34 / Q000276:immunology; D001208:Asia; D001315:Australia; D001938:Brazil; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000276:immunology / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D042783:Endothelial Cells / Q000276:immunology / Q000473:pathology*; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013234:Stem Cells / Q000276:immunology / Q000473:pathology*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000906:Antibodies; D018952:Antigens, CD34; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel; D020123:Sirolimus