Comparison of 6‐month vascular healing response after bioresorbable polymer versus durable polymer drug‐eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study

Abstract

Objectives This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus‐eluting stents (EES) in patients with acute coronary syndromes (ACS). Background Whether BP‐EES induce better vascular healing compared to contemporary DP‐EES remains controversial, especially for ACS. Methods In this prospective, randomized, non‐inferiority trial, we used OCT to compare 6‐month vascular healing in patients with ACS randomized to BP versus DP‐EES: percent strut coverage (primary endpoint, non‐inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated. Results A total of 104 patients with ACS were randomly assigned to BP‐EES (n = 52) versus DP‐EES (n = 52). Of these, 86 patients (40 BP‐EES and 46 DP‐EES) were included in the final OCT analyses. Six‐month percent strut coverage of BP‐EES (83.6 ± 11.4%) was not non‐inferior compared to those of DP‐EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval‐2.6%), pnon‐inferiority = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 μm versus 67.2 ± 33.9 μm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non‐lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005). Conclusions Six‐month strut coverage of BP‐EES was not non‐inferior compared to those of DP‐EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

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

“…We believe that relatively low late of acute stent malapposition after the initial procedure due to OCT-guided PCI have contributed to the results. In fact, a recent OCT analysis demonstrated that acute stent apposition was associated with chronic stent coverage [ 25 ]. It is speculated that ACS are associated with high rate of acute incomplete stent apposition [ 26 ].…”