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 language | English |
|---|---|
| Article number | jey210 |
| Pages (from-to) | 916-924 |
| Number of pages | 9 |
| Journal | European Heart Journal Cardiovascular Imaging |
| Volume | 20 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 1 Aug 2019 |
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Keywords
- Drug-eluting absorbable metal scaffold
- Luminal volume loss
- Optical Coherence Tomography (OCT)
Cite this
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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. / Ozaki, Yuichi; Garcia-Garcia, Hector M.; Hideo-Kajita, Alexandre; Kuku, Kayode O.; Haude, Michael; Ince, Hüseyin; Abizaid, Alexandre; Tölg, Ralph; Lemos, Pedro Alves; von Birgelen, Clemens; Christiansen, Evald Høj; Wijns, William; Escaned, Javier; Dijkstra, Jouke; Waksman, Ron.
In: European Heart Journal Cardiovascular Imaging, Vol. 20, No. 8, jey210, 01.08.2019, p. 916-924.Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - 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
T2 - An optical coherence tomography analysis
AU - Ozaki, Yuichi
AU - Garcia-Garcia, Hector M.
AU - Hideo-Kajita, Alexandre
AU - Kuku, Kayode O.
AU - Haude, Michael
AU - Ince, Hüseyin
AU - Abizaid, Alexandre
AU - Tölg, Ralph
AU - Lemos, Pedro Alves
AU - von Birgelen, Clemens
AU - Christiansen, Evald Høj
AU - Wijns, William
AU - Escaned, Javier
AU - Dijkstra, Jouke
AU - Waksman, Ron
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
KW - Drug-eluting absorbable metal scaffold
KW - Luminal volume loss
KW - Optical Coherence Tomography (OCT)
UR - http://www.scopus.com/inward/record.url?scp=85062575224&partnerID=8YFLogxK
U2 - 10.1093/ehjci/jey210
DO - 10.1093/ehjci/jey210
M3 - Article
VL - 20
SP - 916
EP - 924
JO - European Heart Journal Cardiovascular Imaging
JF - European Heart Journal Cardiovascular Imaging
SN - 2047-2404
IS - 8
M1 - jey210
ER -