The impact of underlying plaque characteristics following the novel resorbable magnesium scaffold implantation: an intravascular OCT assessment up to 12-months

Abstract

Abstract Background Second-generation resorbable magnesium scaffold (RMS) Magmaris showed favorable outcomes in clinical trials, especially regarding the incidence of scaffold thrombosis. The earlier studies reported a higher occurrence of scaffold recoil with this RMS owing to vessel constriction. This finding was shown to be more prominent in presence of underlying fibrous plaques rather than calcific and/or lipidic lesions. This suggest that sufficient radial force along with longer scaffolding time may improve the device performance. Against this background, DREAMS 3G was developed with stronger mechanical properties despite thinner struts by modifying the magnesium alloy of its predecessor. The first-in-man trial BIOMAG-I demonstrated promising results for the novel RMS with respect to clinical and angiographic outcomes at 6 months follow-up. Still, the data concerning the performance of DREAMS 3G scaffold up to 12-months are lacking. Purpose This study aims to assess the influence of the intravascular optical coherence tomography (OCT) -derived underlying plaque characteristics on mean lumen area (mm 2) in patients treated with DREAMS 3G at 6- and 12-months. Methods Patients enrolled in the BIOMAG-I trial and who underwent OCT imaging (i) at index-procedure, (ii) at 6-months and (iii) at 12-months follow-up were included in the current analysis. The acquired intravascular imaging data were evaluated every 1 mm on a quadrant basis to assess the presence of fibrous, calcific, or lipidic lesions. We calculated the proportions of each plaque feature per pullback, then assessed their correlation with the mean lumen area obtained at 6- and 12-months follow-up. In addition, we investigated the potential impact of scaffold edge dissection on the mean lumen area. Results Fifty-one patients and 52 lesions were evaluated in the current analysis. There was no significant correlation between the underlying plaque characteristic and mean lumen area at 6-months (p=0.767 for fibrous, p=0.761 for calcific, p=0.767 for lipid lesions). This trend was similar at 12 months follow-up (p=0.499 for fibrous, p=0.714 for calcific, p=0.569 for lipid lesions). Finally, the presence of edge dissection did not correlate with mean lumen area (p=0.559 and p=0.670 at 6- and 12-months follow-up, respectively). Conclusion The underlying plaque characteristics and the presence of edge dissection had no significant impact on the mean lumen area following DREAMS 3G implantation up to 12 months. These results suggest better device performance with the novel RMS irrespective of the underlying plaque characteristics.