Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis: a serial follow-up at three and six months with optical coherence tomography imaging

Pannipa Suwannasom, Yoshinobu Onuma, Edouard Benit, Olivier Gach, Clemens von Birgelen, Sjoerd H. Hofma, Yohei Sotomi, Xu Bo, Yao-Jun Zhang, Runlin Gao, Hector M. Garcia-Garcia, Joanna J. Wykrzykowska, Robbert J. de Winter, Patrick W. Serruys

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Abstract

Aims: Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing.

Methods and results: In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months.

Conclusions: In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months. (ClinicalTrials.gov Identifier: NCT01925027)

Original languageEnglish
Pages (from-to)e574-e583
JournalEuroIntervention
Volume12
Issue number5
DOIs
Publication statusPublished - 2016

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Coronary Stenosis
Optical Coherence Tomography
Sirolimus
Stents
Blood Vessels
Polymers

Keywords

  • METIS-318968
  • IR-102156
  • Drug-eluting stent(s)
  • Healing score
  • Optical Coherence Tomography (OCT)
  • Polymer-free

Cite this

Suwannasom, Pannipa ; Onuma, Yoshinobu ; Benit, Edouard ; Gach, Olivier ; von Birgelen, Clemens ; Hofma, Sjoerd H. ; Sotomi, Yohei ; Bo, Xu ; Zhang, Yao-Jun ; Gao, Runlin ; Garcia-Garcia, Hector M. ; Wykrzykowska, Joanna J. ; de Winter, Robbert J. ; Serruys, Patrick W. / Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis : a serial follow-up at three and six months with optical coherence tomography imaging. In: EuroIntervention. 2016 ; Vol. 12, No. 5. pp. e574-e583.
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abstract = "Aims: Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing.Methods and results: In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1{\%} at three months to 98.6{\%} at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2{\%} and 0.0{\%} at the two respective time points. Neointimal volume obstruction increased from 6.3{\%} to 12.8{\%}, and the HS decreased from a median of 28.1 at three months to 2.4 at six months.Conclusions: In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months. (ClinicalTrials.gov Identifier: NCT01925027)",
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author = "Pannipa Suwannasom and Yoshinobu Onuma and Edouard Benit and Olivier Gach and {von Birgelen}, Clemens and Hofma, {Sjoerd H.} and Yohei Sotomi and Xu Bo and Yao-Jun Zhang and Runlin Gao and Garcia-Garcia, {Hector M.} and Wykrzykowska, {Joanna J.} and {de Winter}, {Robbert J.} and Serruys, {Patrick W.}",
year = "2016",
doi = "10.4244/EIJV12I5A97",
language = "English",
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Suwannasom, P, Onuma, Y, Benit, E, Gach, O, von Birgelen, C, Hofma, SH, Sotomi, Y, Bo, X, Zhang, Y-J, Gao, R, Garcia-Garcia, HM, Wykrzykowska, JJ, de Winter, RJ & Serruys, PW 2016, 'Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis: a serial follow-up at three and six months with optical coherence tomography imaging', EuroIntervention, vol. 12, no. 5, pp. e574-e583. https://doi.org/10.4244/EIJV12I5A97

Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis : a serial follow-up at three and six months with optical coherence tomography imaging. / Suwannasom, Pannipa; Onuma, Yoshinobu; Benit, Edouard; Gach, Olivier; von Birgelen, Clemens; Hofma, Sjoerd H.; Sotomi, Yohei; Bo, Xu; Zhang, Yao-Jun; Gao, Runlin; Garcia-Garcia, Hector M.; Wykrzykowska, Joanna J.; de Winter, Robbert J.; Serruys, Patrick W.

In: EuroIntervention, Vol. 12, No. 5, 2016, p. e574-e583.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis

T2 - a serial follow-up at three and six months with optical coherence tomography imaging

AU - Suwannasom, Pannipa

AU - Onuma, Yoshinobu

AU - Benit, Edouard

AU - Gach, Olivier

AU - von Birgelen, Clemens

AU - Hofma, Sjoerd H.

AU - Sotomi, Yohei

AU - Bo, Xu

AU - Zhang, Yao-Jun

AU - Gao, Runlin

AU - Garcia-Garcia, Hector M.

AU - Wykrzykowska, Joanna J.

AU - de Winter, Robbert J.

AU - Serruys, Patrick W.

PY - 2016

Y1 - 2016

N2 - Aims: Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing.Methods and results: In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months.Conclusions: In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months. (ClinicalTrials.gov Identifier: NCT01925027)

AB - Aims: Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing.Methods and results: In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months.Conclusions: In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months. (ClinicalTrials.gov Identifier: NCT01925027)

KW - METIS-318968

KW - IR-102156

KW - Drug-eluting stent(s)

KW - Healing score

KW - Optical Coherence Tomography (OCT)

KW - Polymer-free

U2 - 10.4244/EIJV12I5A97

DO - 10.4244/EIJV12I5A97

M3 - Article

VL - 12

SP - e574-e583

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 5

ER -