Critique of the OPTIMIS study on magnesium-based bioresorbable scaffolds
To the Editor,
We read with interest the article by Hansen et al. titled “Effect of optimal lesion preparation prior to implantation of a magnesium-based bioresorbable scaffold: 12-month results of the OPTIMIS study” (Cardiovasc Revasc Med. 2025;77:45–53) [
1]. The study investigates the impact of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implantation of a magnesium-based bioresorbable scaffold (MgBRS). While the study provides valuable insights into lesion preparation techniques, we identified several concerns regarding internal inconsistencies, discrepancies with existing literature, and methodological limitations that warrant discussion.
The study reports no significant difference in minimal lumen area (MLA) at 12 months between the scoring balloon (4.6 ± 0.5 mm
2) and standard non-compliant balloon (3.6 ± 0.5 mm
2) groups (
p = 0.16). However, Table 3 presents MLA values at 12 months as 4.56 ± 0.48 mm
2 (scoring) and 3.61 ± 0.47 mm
2 (standard), with a
p-value of 0.16, conflicting with values in the abstract and conclusion (4.6 ± 1.6 mm
2 vs. 4.2 ± 2.0 mm
2,
p = 0.60) [
1]. This discrepancy raises concerns about data accuracy. Could the authors clarify which values are correct and whether this affects the primary endpoint interpretation? Additionally, the study highlights no target lesion revascularization (TLR) in the scoring balloon group compared to seven in the standard balloon group, but the discussion notes six TLR events (p. 50), contradicting the results and supplementary data. We request clarification on the exact number of TLR events and the basis for this inconsistency.