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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

DOI:10.1093/ehjci/jey210 期刊:European Heart Journal - Cardiovascular Imaging 出版年份:2018 更新时间:2025-09-23 15:22:29
摘要: Aims 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) mm3 vs. non-over-expansion: 21.0 (11.6–37.9) mm3, 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.
作者: Yuichi Ozaki,Hector M. Garcia-Garcia,Alexandre Hideo-Kajita,Kayode O. Kuku,Michael Haude,Hüseyin Ince,Alexandre Abizaid,Ralph T?lg,Pedro Alves Lemos,Clemens von Birgelen,Evald H?j Christiansen,William Wijns,Javier Escaned,Jouke Dijkstra,Ron Waksman
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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.

Excellent healing was observed with DREAMS 2G, but higher expansion indices were associated with greater luminal volume loss, suggesting that excessive expansion should be avoided to reduce in-scaffold LVL.

Small sample size, short 6-month follow-up period, exclusion of complex lesions and STEMI patients, lack of pre-implantation OCT, and non-randomized design.

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