title: Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial.
abstract: BACKGROUND
  Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions.
  
  
  METHODS
  We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504.
  
  
  RESULTS
  Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed.
  
  
  CONCLUSIONS
  Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease.
  
  
  BACKGROUND
  Biotronik AG.
authors.affiliation: Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. Electronic address: mhaude@lukasneuss.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.affiliation: Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, Berlin, Germany.
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
authors.affiliation: Instituto de Cardiologia Dante Pazzanese, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany.
authors.forename: Ralph
authors.initials: R
authors.lastname: Toelg
authors.affiliation: Instituto do Coração-HCFMUSP, University of São Paulo, São Paulo.
authors.forename: Pedro Alves
authors.initials: PA
authors.lastname: Lemos
authors.affiliation: Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, Netherlands.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.affiliation: Department of Cardiology, University Hospital, Basel, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.affiliation: Department of Cardiology, Lausanne University Hospital, Switzerland.
authors.forename: Eric
authors.initials: E
authors.lastname: Eeckhout
authors.affiliation: Department of Cardiology, National Heart Center Singapore, Singapore.
authors.forename: Soo Teik
authors.initials: ST
authors.lastname: Lim
authors.affiliation: Division of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.affiliation: Cardialysis BV, Rotterdam, Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000497:Alloys; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D015331:Cohort Studies; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000473:pathology*; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents; D019160:Endosonography; D005260:Female; D006801:Humans; D008274:Magnesium; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use*; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D000497:Alloys; D000903:Antibiotics, Antineoplastic; D008274:Magnesium; D020123:Sirolimus