title: Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial.
abstract: BACKGROUND
  Coronary stents improve immediate and late results of balloon angioplasty by tacking up dissections and preventing wall recoil. These goals are achieved within weeks after angioplasty, but with current technology stents permanently remain in the artery, with many limitations including the need for long-term antiplatelet treatment to avoid thrombosis. We report a prospective multicentre clinical trial of coronary implantations of absorbable magnesium stents.
  
  
  METHODS
  We enrolled 63 patients (44 men; mean age 61.3 [SD 9.5 years]) in eight centres with single de novo lesions in a native coronary artery in a multicentre, non-randomised prospective study. Follow-up included coronary angiography and intravascular ultrasound at 4 months and clinical assessment at 6 months and 12 months. The primary endpoint was cardiac death, non-fatal myocardial infarction, or clinically driven target lesion revascularisation at 4 months
  
  
  RESULTS
  71 stents, 10-15 mm in length and 3.0-3.5 mm in diameter, were successfully implanted after pre-dilatation in 63 patients. Diameter stenosis was reduced from 61.5 (SD 13.1%) to 12.6 (5.6%) with an acute gain of 1.41 mm (0.46 mm) and in-stent late loss of 1.08 mm (0.49 mm). The ischaemia-driven target lesion revascularisation rate was 23.8% after 4 months, and the overall target lesion revascularisation rate was 45% after 1 year. No myocardial infarction, subacute or late thrombosis, or death occurred. Angiography at 4 months showed an increased diameter stenosis of 48.4 (17.0%). After serial intravascular ultrasound examinations, only small remnants of the original struts were visible, well embedded into the intima. Neointimal growth and negative remodelling were the main operating mechanisms of restenosis.
  
  
  CONCLUSIONS
  This study shows that biodegradable magnesium stents can achieve an immediate angiographic result similar to the result of other metal stents and can be safely degraded after 4 months. Modifications of stent characteristics with prolonged degradation and drug elution are currently in development.
authors.affiliation: West-German Heart Center Essen, Department of Cardiology, Essen, Germany. Electronic address: erbel@uk-essen.de.
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
authors.affiliation: Royal Brompton Hospital, Imperial College London, London, UK.
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
authors.affiliation: Cardiovascular Centre, OLV Ziekenhuis, Aalst, Belgium.
authors.forename: Jozef
authors.initials: J
authors.lastname: Bartunek
authors.affiliation: Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Johann
authors.initials: J
authors.lastname: Bonnier
authors.affiliation: Cardiovascular Centre, OLV Ziekenhuis, Aalst, Belgium.
authors.forename: Bernard
authors.initials: B
authors.lastname: de Bruyne
authors.affiliation: Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Franz R
authors.initials: FR
authors.lastname: Eberli
authors.affiliation: Cardiology Department, Kantonal Hospital, Lucerne, Switzerland.
authors.forename: Paul
authors.initials: P
authors.lastname: Erne
authors.affiliation: West-German Heart Center Essen, Department of Cardiology, Essen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.affiliation: Hannover Medical School, Leibniz Laboratory for Biotechnology and Artificial Organs, Hannover, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Heublein
authors.affiliation: Cardiology Department, Austin and Repatriation Medical Centre, Victoria, Melbourne, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Horrigan
authors.affiliation: Harefield Hospital, Imperial College London, London, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Ilsley
authors.affiliation: West-German Heart Center Essen, Department of Cardiology, Essen, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Böse
authors.affiliation: Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.affiliation: Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.affiliation: Washington Hospital Center, Washington DC, USA.
authors.forename: Neil
authors.initials: N
authors.lastname: Weissman
authors.affiliation: Washington Hospital Center, Washington DC, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D020341:Absorbable Implants; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003328:Coronary Thrombosis / Q000517:prevention & control; D023381:Endpoint Determination / Q000379:methods; D004867:Equipment Design; D005260:Female; D006801:Humans; D007902:Length of Stay; D008274:Magnesium; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D014463:Ultrasonography
chemical_list: D008274:Magnesium