Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment

Circ Cardiovasc Interv. 2013 Dec;6(6):644-53. doi: 10.1161/CIRCINTERVENTIONS.113.000693. Epub 2013 Nov 19.


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.

Methods and 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.

Clinical trial registration: URL: Unique identifier: NCT01168830.

Keywords: bioabsorbable magnesium scaffold; coronary geometry; echogenicity; neointima; vasomotion.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants*
  • Angioplasty / instrumentation*
  • Angioplasty / methods
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / therapy*
  • Everolimus
  • Follow-Up Studies
  • Humans
  • Incidence
  • Magnesium*
  • Neointima / diagnostic imaging
  • Neointima / epidemiology
  • Sirolimus / analogs & derivatives*
  • Tissue Scaffolds*
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Ultrasonography, Interventional


  • Everolimus
  • Magnesium
  • Sirolimus

Associated data