Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial)

Am J Cardiol. 2019 Apr 1;123(7):1044-1051. doi: 10.1016/j.amjcard.2018.12.029. Epub 2019 Jan 4.

Abstract

Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is used for treating coronary lesions. However, the natural history of the jailed side-branch (SB) after DREAMS 2G implantation remains to be elucidated. The aim of this study is to investigate the effect of scaffold struts on jailed SBs as assessed by 3-dimensional (3D) optical coherence tomography (OCT) after implantation of DREAMS 2G. We enrolled the patients who received a DREAMS 2G implantation and where OCT was performed at postprocedure and 12-month follow-up in the BIOSOLVE-II trial. The area of the ostium of jailed SBs and number of compartments divided by scaffold struts were assessed by cut-plane analysis using 3D OCT. A total of 24 patients with 61 jailed SBs were analyzed in this study. The number of compartments was significantly decreased (postprocedure; 1.98 ± 0.84 vs 12 months; 1.10 ± 0.30, p <0.001) during the 12 months. Since most of the struts disappeared, the ostium area was increased in 62% of jailed SBs at 12 months, however, not significantly different from postprocedure (postprocedure; 0.74 [0.34 to 1.46] mm2 vs 12 months; 0.78 [0.41 to 1.68] mm2, p = 0.055). The number of compartments created by scaffold struts and branching angle at postprocedure had no effect on the changes of SB ostium area. DREAMS 2G has a favorable absorption process in the jailed SBs up to 12 months and may be considered as an optional therapy for treating lesions that involve SBs.

Trial registration: ClinicalTrials.gov NCT01960504.

Publication types

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

MeSH terms

  • Absorbable Implants*
  • Aged
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / surgery*
  • Coronary Vessels / diagnostic imaging*
  • Coronary Vessels / surgery
  • Drug-Eluting Stents*
  • Female
  • Follow-Up Studies
  • Humans
  • Imaging, Three-Dimensional / methods*
  • Male
  • Percutaneous Coronary Intervention / methods*
  • Prospective Studies
  • Prosthesis Design
  • Reproducibility of Results
  • Tissue Scaffolds
  • Tomography, Optical Coherence / methods*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01960504