Twelve-months vessel healing profile following the novel resorbable magnesium scaffold implantation: an intravascular OCT analysis of the BIOMAG-I trial

Abstract

Background

The first-in-human trial of the latest resorbable magnesium scaffold (RMS), DREAMS 3G, showed favorable clinical and angiographic outcomes up to 6-months. An intravascular optical coherence tomography (OCT) assessment of the vascular healing profile at 6 months and 12 months follow-up may serve as additional supportive evidence for device safety and efficacy.

Purpose

The aim of this study was to evaluate the vessel healing process by quantifying the presence of strut protrusion (SP) and strut degradation following DREAMS 3G implantation as per intravascular OCT imaging.

Methods

Patients from the BIOMAG-I trial who underwent OCT imaging at both 6- and 12-months were deemed eligible. This resulted in the inclusion of a total of 51 patients and 52 lesions in the current analysis. The acquired intravascular imaging data were evaluated every 1 mm to visualize and quantify the SP and the number of visible struts at 6- and 12-months. In addition, we investigated the potential impact of SP on mean and minimum lumen area (mm2) at both time point.

Results

At 12 months, the mean SP area was significantly smaller in comparison to 6 months follow-up (1.87±2.22 mm2 at 6 months vs. 0.99±1.27 mm2 at 12 months, p<0.001). There was a positive correlation between SP area and mean lumen area at both 6 months (p<0.001) and 12 months (p=0.014) follow-up. Similarly, a positive correlation was observed between SP area and minimum lumen area up to 6 months (p=0.006 at 6 months, p=0.323 at 12 months). The number of visible struts was 6.44±7.59 at 6 months and 1.79±0.85 at 12 months (p<0.001).

Conclusion

The SP area was larger in lesions with greater lumen area following the implantation of the novel RMS. The observed SP area was significantly smaller at 12 months in comparison to 6 months follow-up. These results suggest that the presence of SP is part of a favorable vascular healing process following the treatment with the latest resorbable magnesium scaffold.