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

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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
Article numberjey210
Pages (from-to)916-924
Number of pages9
JournalEuropean Heart Journal Cardiovascular Imaging
Volume20
Issue number8
DOIs
Publication statusPublished - 1 Aug 2019

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Optical Coherence Tomography
Coronary Vessels
Metals
Pharmaceutical Preparations
Dissection
Equipment and Supplies

Keywords

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

Cite this

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. / 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. In: European Heart Journal Cardiovascular Imaging. 2019 ; Vol. 20, No. 8. pp. 916-924.
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title = "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",
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.",
keywords = "Drug-eluting absorbable metal scaffold, Luminal volume loss, Optical Coherence Tomography (OCT)",
author = "Yuichi Ozaki and Garcia-Garcia, {Hector M.} and Alexandre Hideo-Kajita and Kuku, {Kayode O.} and Michael Haude and H{\"u}seyin Ince and Alexandre Abizaid and Ralph T{\"o}lg and Lemos, {Pedro Alves} and {von Birgelen}, Clemens and Christiansen, {Evald H{\o}j} and William Wijns and Javier Escaned and Jouke Dijkstra and Ron Waksman",
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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 journalArticleAcademicpeer-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)

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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

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M1 - jey210

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