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

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.

Early vascular healing of ultra-thin strut polymer-free sirolimus-eluting stents in acute coronary syndrome: USUI-ACS study

“…Our data demonstrated that the strut coverage of UPF-SES in ACS patients was comparable to that of FRIENDLY OCT trial (98.4% vs. 96.89%, respectively) even though our study population had higher risk of delayed healing than the population of FRIENDLY OCT trial. Moreover, the comparison of the 3 month follow-up OCT findings in patients with ACS among the present study and several previously reported studies was shown in the Supplementary Table 1 [ 15 – 17 ]. The percentage of covered struts and malapposed struts in UPF-SES were comparable as compared to those of other recent DESs [ 15 – 17 ].…”

“…Moreover, the comparison of the 3 month follow-up OCT findings in patients with ACS among the present study and several previously reported studies was shown in the Supplementary Table 1 [ 15 – 17 ]. The percentage of covered struts and malapposed struts in UPF-SES were comparable as compared to those of other recent DESs [ 15 – 17 ]. Of course, our sample size were very small and the patient population in the current study was completely different compared to the other studies mentioned above.…”

“…Concerning the pathology, it has been reported that vessel healing of DESs in patients with ACS is substantially delayed as compared to that in those with stable angina [ 14 ]. Actually, MECHANISM-ULTIMASTER study, the study evaluated the serial vascular healing of BP-SES, showed that the percentage of covered struts were significantly lower in STEMI patients than in non-ACS patients [ 15 ]. The recent OCT analysis of UPF-SES, FRIENDLY OCT trial, showed that the percentage of covered struts at 3 months was significantly higher in UPF-SES than BP-SES (96.89% vs. 94.65%; p < 0.001, respectively) in patients with non-ACS, NSTEMI and UA [ 5 ].…”

Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents

“…The long-term safety of Ultimaster was confirmed by the low rate of late in-stent thrombosis. These favorable antithrombotic properties of the scaffold have been demonstrated in the in vitro models [ 19 ] and are associated with an accelerated tissue coverage and scaffold apposition [ 3 , 20 ] leading to improved vessel healing. Noteworthy, the presence of the “class effect” for all bioresorbable polymer stents is very likely [ 21 ].…”

Incidence and natural history of coronary evagination after implanted biodegradable polymer sirolimus-eluting stent

“…The protocol and main results of the MECHANISM-elective study have been reported in detail. 3 All culprit lesions were treated with either one or two Ultimaster BP-SES in standard fashion. The endpoint was the presence of CE at either 1 or 3, and 12 months of the follow-up period.…”