title: First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study.
abstract: This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.
  
  
  
  Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.
  
  
  
  The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data.
  
  
  
  Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority<0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.
  
  
  
  At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).
authors.affiliation: Cardiovascular Research Centre, Royal Adelaide Hospital and Cardiac Unit, St Andrews Hospital, Adelaide, Australia. Electronic address: stephen.worthley@genesiscare.com.au.
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Worthley
authors.affiliation: Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, Cardiovascular Research Center, and Hospital Israelita Albert Einstein, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Department of Medicine-Cardiovascular Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Simon
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Clinical Research Department, Medtronic, Santa Rosa, California.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Brar
authors.affiliation: Monash Health and Monash University, Melbourne, Australia.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.affiliation: Department of Cardiology, Fiona Stanley Hospital, Murdoch, Australia, and University of Western Australia, Perth, Australia.
authors.forename: Sharad
authors.initials: S
authors.lastname: Shetty
authors.affiliation: Heart and Vascular Institute, Flinders Medical Centre, Bedford Park, Australia.
authors.forename: Ajay
authors.initials: A
authors.lastname: Sinhal
authors.affiliation: Cardiovascular Imaging Core Lab, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Alexandra Popma
authors.initials: AP
authors.lastname: Almonacid
authors.affiliation: Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, Cardiovascular Research Center, and Hospital Israelita Albert Einstein, São Paulo, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chamié
authors.affiliation: Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.affiliation: Department of Medicine, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D001315:Australia; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D012846:Singapore; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D013635:Tantalum; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002858:Chromium Alloys; D010975:Platelet Aggregation Inhibitors; D013635:Tantalum; C489443:zotarolimus; D020123:Sirolimus
keywords: drug-eluting stent(s); drug-filled stent(s); percutaneous coronary intervention; polymer-free stent