Impact of procedural characteristics on coronary vessel wall healing following implantation of second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary artery lesions: An optical coherence tomography analysis

Yuichi Ozaki, Hector M. Garcia-Garcia*, Alexandre Hideo-Kajita, Kayode O. Kuku, Michael Haude, Hüseyin Ince, Alexandre Abizaid, Ralph Tölg, Pedro Alves Lemos, Clemens von Birgelen, Evald Høj Christiansen, William Wijns, Javier Escaned, Jouke Dijkstra, Ron Waksman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Scopus)

Abstract

Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold dimensions after implantation of DREAMS 2G and vessel healing and luminal results at follow-up is unknown. The aim of this study is, therefore, to investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall. Methods and results: This study comprises of a total 65 out of 123 patients who were enrolled in the BIOSOLVE-II trial. We assessed both qualitative and quantitative OCT findings and the expansion index of DREAMS 2G after implantation frame by frame using OCT. Expansion index was defined as minimum scaffold area/mean reference lumen area. The over-expansion group was also defined with expansion index >1.0. The total number of analysed frames at post-procedure and 6-month follow-up was 8243 and 8263 frames, respectively. At 6-month follow-up, in-scaffold healing was documented by the reduction of 82% in dissections, 93% in attached intra-luminal mass (ILM), 65% in non-attached ILM, and 76% in jailed side branch. The over-expansion group had significantly greater in-scaffold luminal volume loss (LVL) compared with the non-over-expansion group [over-expansion: 35.0 (18.5-52.1) mm vs. non-over-expansion: 21.0 (11.6-37.9) mm, P = 0.039]. Conclusion: Excellent in vivo healing process after implantation of DREAMS 2G was observed at 6 months. We found that higher expansion indices were associated with higher in-scaffold LVL at 6 months assessed by OCT.

Original languageEnglish
Pages (from-to)916-924
Number of pages9
JournalEuropean Heart Journal Cardiovascular Imaging
Volume20
Issue number8
DOIs
Publication statusPublished - 1 Aug 2019

Keywords

  • Drug-eluting absorbable metal scaffold
  • Luminal volume loss
  • Optical Coherence Tomography (OCT)

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