title: Rationale and design of the randomized, multicenter EREMUS trial, a study that investigates how to achieve low restenosis and early reendothelialization after percutaneous coronary interventions.
abstract: BACKGROUND
  Drug eluting stent (DES) use has improved clinical outcome after percutaneous coronary interventions. However, DES-treated patients may have a higher risk of stent thrombosis, mainly due to uncorrect stent deployment or lack of reendothelialization. Thus, the availabilily of different approaches with comparable efficacy to DES, but higher safety, especially in bleeding-prone patients, have to be investigated.
  
  
  METHODS
  The EREMUS is a multicenter open-label prospective randomized three-arm clinical trial that will investigate the efficacy of a paclitaxel coated balloon + an endothelial progenitor capture stent for the treatment of native coronary lesions, and compare it to a DES strategy, or the sole endothelial progenitor capture stent. An angiographic follow-up with optical coherence tomography analysis will be scheduled 9 months after index procedure. Noninferiority regarding the primary endpoint (late luminal loss) between study group and DES is hypothesized. All patients will undergo clinical follow-up until 24 months from index hospitalization.
  
  
  CONCLUSIONS
  The EREMUS trial will determine whether a composite approach with a paclitaxel coated balloon + an endothelial progenitor capture stent in coronary lesions at medium-to-high risk of restenosis will achieve similar results compared to DES regarding inhibition of intrastent proliferation; complete stent strut reendothelialization, a safety issue, will also be investigated.
authors.affiliation: Interventional Cardiology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy. bcortese@gmail.com
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.forename: Gian Battista
authors.initials: GB
authors.lastname: Danzi
authors.forename: Antonino
authors.initials: A
authors.lastname: Pitì
authors.forename: Silva
authors.initials: S
authors.lastname: Severi
authors.forename: Ugo
authors.initials: U
authors.lastname: Limbruno
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage; D049109:Cell Proliferation; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D042783:Endothelial Cells / Q000473:pathology*; D006801:Humans; D007558:Italy; D017239:Paclitaxel / Q000008:administration & dosage; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D018570:Risk Assessment; D013234:Stem Cells / Q000473:pathology*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel