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. 2022 Apr;37(2):281-292.
doi: 10.1007/s12928-021-00777-4. Epub 2021 Apr 25.

A serial optical frequency-domain imaging study of early and late vascular responses to bioresorbable-polymer sirolimus-eluting stents for the treatment of acute myocardial infarction and stable coronary artery disease patients: results of the MECHANISM-ULTIMASTER study

Tomonori Itoh #  1 , Hiromasa Otake #  2 , Takumi Kimura  3 , Yoshiro Tsukiyama  2 , Tatsuo Kikuchi  4 , Munenori Okubo  5 , Takatoshi Hayashi  6 , Takayuki Okamura  7 , Shoichi Kuramitsu  8 , Takashi Morita  9 , Shinjo Sonoda  10 , Shozo Ishihara  11 , Nehiro Kuriyama  12 , Takaaki Isshiki  13 , Tsunenari Soeda  14 , Kiyoshi Hibi  15 , Toshiro Shinke  16 , Yoshihiro Morino  3 ; MECHANISM-ULTIMASTER study group
Collaborators, Affiliations

A serial optical frequency-domain imaging study of early and late vascular responses to bioresorbable-polymer sirolimus-eluting stents for the treatment of acute myocardial infarction and stable coronary artery disease patients: results of the MECHANISM-ULTIMASTER study

Tomonori Itoh et al. Cardiovasc Interv Ther. 2022 Apr.

Abstract

The purpose of this study was to assess early and late vascular healing in response to bioresorbable-polymer sirolimus-eluting stents (BP-SESs) for the treatment of patients with ST-elevation myocardial infarction (STEMI) and stable coronary artery disease (CAD). A total of 106 patients with STEMI and 101 patients with stable-CAD were enrolled. Optical frequency-domain images were acquired at baseline, at 1- or 3-month follow-up, and at 12-month follow-up. In the STEMI and CAD cohorts, the percentage of uncovered struts (%US) was significantly and remarkably decreased during early two points and at 12-month (the STEMI cohort: 1-month: 18.75 ± 0.78%, 3-month: 10.19 ± 0.77%, 12-month: 1.80 ± 0.72%; p < 0.001, the CAD cohort: 1-month: 9.44 ± 0.78%, 3-month: 7.78 ± 0.78%, 12-month: 1.07 ± 0.73%; p < 0.001 respectively). The average peri-strut low-intensity area (PLIA) score in the STEMI cohort was significantly decreased during follow-up period (1.90 ± 1.14, 1.18 ± 1.25, and 1.01 ± 0.72; p ≤ 0.001), whereas the one in the CAD cohort was not significantly changed (0.89 ± 1.24, 0.67 ± 1.07, and 0.64 ± 0.72; p = 0.59). In comparison with both groups, differences of %US and PLIA score at early two points were almost disappeared or close at 12 months. The strut-coverage and healing processes in the early phase after BP-SES implantation were significantly improved in both cohorts, especially markedly in STEMI patients. At 1 year, qualitatively and quantitatively consistent neointimal coverage was achieved in both pathogenetic groups.

Keywords: Bioresorbable-polymer sirolimus-eluting stents; Optical frequency-domain images; ST-elevation myocardial infarction; Stable coronary artery disease.

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Conflict of interest statement

Itoh T, MD received lecture fees from Abbott Medical Japan and Daiichi-Sankyo, Otake H, MD received lecture fees from TERUMO, Sanofi, and Daiichi-Sankyo, grants and lecture fees from Abbott vascular, Shinke T, MD received grants from Terumo during the conduct of the study; lecture fees from Abbott Vascular, Sanofi, and Daiichi-Sankyo, grants and lecture fees from Bayer, Ishihara S, MD received lecture fees from Terumo, Abbott Medical Japan and Daiichi-Sankyo, Isshiki T, MD received lecture fees from Abott Medical Japan and Daiichi-Sankyo, Morino Y, MD received grants from Terumo during the conduct of the study; lecture fees from Abbott Vascular, Sanofi, and Daiichi-Sankyo, grants and lecture fees from Boston Scientific, Kimura T MD, Tsukiyama Y, MD, Kikuchi T MD, Okubo M MD, Hayashi T MD, Ph.D. and MBS, Okamura T MD, Kuramitsu S MD, Morita T MD, Soeda T MD, Sonoda S MD, Kuriyama N MD, and Hibi K MD have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Study protocol and patient flowchart for this study
Fig. 2
Fig. 2
OFDI analysis: a uncovered struts; b malapposed struts; c stent and lumen area; d thrombus (a mass attached of the luminal surface stent strut or floating within the lumen); e PLIA score: Grade 0; f Grade 1; g Grade 2; h Grade 3
Fig. 3
Fig. 3
The percentage of uncovered struts (a) and averaged neointimal thickness (b) at each follow-up visit in the both groups
Fig. 4
Fig. 4
Incidence of PLIA score in the two pathogenetic groups: a the STEMI cohort: prevalence of high PLIA score (2 and 3) was significantly decreased during the follow-up period. p < 0.001* at 3 months, p < 0.001** at 12 months (reference 1 month). b The CAD cohort: p = 0.82 at 3 months, p = 0.12 at 12 months (reference 1 month)
See this image and copyright information in PMC

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