Key result
Scoring balloon pre-dilatation before bioresorbable scaffold implantation fails to improve lumen area but eliminates TLRs.
Why the study?
Lumen reduction after bioresorbable scaffold implantation has been reported, prompting investigation into whether pre-dilatation with a scoring balloon versus a standard non-compliant balloon before magnesium-based bioresorbable scaffold implantation influences lumen measurements and clinical outcomes.
Does pre-dilatation with a scoring balloon compared to a standard non-compliant balloon improve minimal lumen area and clinical outcomes in patients receiving a magnesium-based bioresorbable scaffold?
RCT (n=82)
Randomly assigned
Does pre-dilatation with a scoring balloon compared to a standard non-compliant balloon improve minimal lumen area and clinical outcomes in patients receiving a magnesium-based bioresorbable scaffold?
Pre-dilatation with a scoring balloon before magnesium-based bioresorbable scaffold implantation did not significantly improve 12-month minimal lumen area but was associated with freedom from target lesion revascularization compared to standard non-compliant balloon pre-dilatation.
Scoring balloon predilation yielded larger 6-month MLA but no 12-month difference; leaves open optimal MgBRS preparation strategy.
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 2 vs. standard 3.6 ± 0.5 mm 2 , 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 2 –5.1 ± 1.7 mm 2 –5.0 ± 1.9 mm 2 , p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm 2 –5.2 ± 1.5 mm 2 –5.3 ± 2.0 mm 2 , 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. • After 12 months, minimal lumen area in lesions treated with a magnesium-based bioresorbable scaffold showed no significant difference between lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. • In both groups, lumen reduction occurred within the first 6 months and remained stable up to 12 month follow-up. • However, only lesions pre-dilated with a scoring balloon were free from TLR.
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Hansen et al. (2025) conducted an RCT in Coronary artery stenosis (n=82). Pre-dilatation with a scoring balloon vs. Standard non-compliant balloon was evaluated on Minimal lumen area (MLA) at 12 months (p=0.16). Pre-dilatation with a scoring balloon before bioresorbable scaffold implantation did not improve 12-month minimal lumen area (P=0.16), but eliminated target lesion revascularizations (0 vs 7).
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