title: Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment.
abstract: BACKGROUND
  The drug-eluting absorbable metal scaffold has demonstrated feasibility, safety, and promising clinical and angiographic outcomes at 12 months in human coronary arteries. This study aimed to evaluate the degradation rate and long-term vascular responses to drug-eluting absorbable metal scaffold.
  
  
  RESULTS
  BIOSOLVE-I was a multicenter, single-arm, first-in-man trial assessing the safety and performance of drug-eluting absorbable metal scaffold in 46 patients with coronary artery disease. Patients who underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography, at 6 and 12 months were included in this study. From postimplantation to follow-up, arterial curvature and angulation were significantly increased by the degradation process. The greatest increase was seen from postimplantation to 6 months. The systolic-diastolic changes of the curvature and angulation gradually improved throughout the follow-up period. At the site of implantation, vasoconstriction (-10% mean reduction) was observed during the acetylcholine test at 6 months. The average percent hyperechogenicity of the scaffolded segments showed a continuous decrease over time, with the most pronounced changes within the first 6 months (from 22.1±7.0% to 15.8±3.7%; P<0.001). Struts discernible on optical coherence tomography at 6 and 12 months showed full neointimal coverage, with stabilization of the mean scaffold area from 6 to 12 months. Furthermore, the mean neointimal area (1.55±0.51 versus 1.58±0.34 mm(2); P=0.794) remained unchanged from 6 to 12 months.
  
  
  CONCLUSIONS
  This serial analysis of drug-eluting absorbable metal scaffold confirmed the safety and efficacy of this new device, with vasomotion restoration and continued degradation over time demonstrated by multi-invasive imaging modalities.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01168830.
authors.affiliation: From the Department of Cardiology, MedStar Washington Hospital Center, Washington, DC (R.W., H.K.); CLI Foundation, Ettore Sansavini Health Science Foundation, Rome, Italy (F.P., L.D.V.); Department of Cardiology, Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands (N.B.); Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Medical Clinic I, Neuss, Germany (M.H., H.D.); Department of Cardiology, West German Heart Center Essen, Essen, Germany (D.B., R.E.); Department of Cardiology, Luzerner Kantonsspital, Lucerne, Switzerland (P.E.); Department of Cardiology, ZNA Middelheim, Antwerp, Belgium (S.V., P.V.); and Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands (J.K.).
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.forename: Nico
authors.initials: N
authors.lastname: Bruining
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Dirk
authors.initials: D
authors.lastname: Böse
authors.forename: Hironori
authors.initials: H
authors.lastname: Kitabata
authors.forename: Paul
authors.initials: P
authors.lastname: Erne
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Hubertus
authors.initials: H
authors.lastname: Degen
authors.forename: Paul
authors.initials: P
authors.lastname: Vermeersch
authors.forename: Luca
authors.initials: L
authors.lastname: Di Vito
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
mesh_terms: D020341:Absorbable Implants; D017130:Angioplasty / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D000068338:Everolimus; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008274:Magnesium; D058426:Neointima / Q000000981:diagnostic imaging / Q000453:epidemiology; D020123:Sirolimus / Q000031:analogs & derivatives*; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D000068338:Everolimus; D008274:Magnesium; D020123:Sirolimus
keywords: bioabsorbable magnesium scaffold; coronary geometry; echogenicity; neointima; vasomotion