Hansen Kirstine Nørregaard, Maehara Akiko, Trøan Jens, Noori Manijeh, Hougaard Mikkel, Ellert Julia, Veien Karsten Tange, Junker Anders, Hansen Henrik Steen, Lassen Jens Flensted, Jensen Lisette Okkels
Department of Cardiology, Odense University Hospital, Odense, Denmark; University of Southern Denmark, Odense, Denmark.
Cardiovasc.lar Research Foundation, New York Presbyterian Hospital, New York, USA.
Cardiovasc Revasc Med. 2025 Aug;77:45-53. doi: 10.1016/j.carrev.2025.03.003. Epub 2025 Mar 5.
Lumen reduction after bioresorbable scaffold implantation has been reported. This study aimed to assess the influence of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implanting a magnesium-based Magmaris bioresorbable scaffold (MgBRS) on lumen measurements using optical coherence tomography (OCT) and on clinical outcomes after 12 months.
In the OPTIMIS-study (Optimal lesion preparation before implantation of a MgBRS in patients with coronary artery stenosis), patients were randomly assigned to pre-dilatation with a scoring balloon or a standard non-compliant balloon before MgBRS implantation. OCT was performed before and after scaffold implantation, and at 6- and 12-month follow-up. Clinical 12-month follow-up was performed for all 82 enrolled patients.
Serial pre- and post-procedural, 6- and 12-month OCT were available in 33 lesions (scoring: n = 16 vs. standard: n = 17). Minimal lumen area (MLA) (scoring 4.6 ± 0.5 mm vs. standard 3.6 ± 0.5 mm, p = 0.16) did not differ significantly at 12 months. In both the scoring and standard non-compliant balloon group, MLA changed significantly over time (post-procedure - 6-month - 12-month) (scoring balloon: 7.2 ± 1.8 mm-5.1 ± 1.7 mm-5.0 ± 1.9 mm, p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm-5.2 ± 1.5 mm-5.3 ± 2.0 mm, p < 0.01). No target lesion revascularizations (TLR) occurred in the scoring balloon group, compared to 7 TLR in the standard non-compliant balloon group within 12 months.
In lesions treated with MgBRS, MLA did not differ significantly after 12 months among lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. However, only lesions pre-dilated with a scoring balloon were free from TLR.
