Abstract
Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced.Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT).Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001).Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria.
Highlights
As the latest innovation in coronary stent therapy, the bioresorbable scaffold (BRS) was rapidly embraced by the interventional cardiologist community due to its potential for long-term benefits and for overcoming limitations inherent to existing drug eluting metallic stents (DES) [1]
The following parameters were assessed during post-hoc analysis: reference vessel diameter (RVD) through automatic interpolation, minimum lumen diameter (MLD), percentage area stenosis (AS), and lesion length
Chi-square and Fisher’s exact test were used for comparison of categorical variables, and Student’s t-test or the Wilcoxon rank-sum test was applied for continuous variables. p < 0.05 were considered statistically significant
Summary
As the latest innovation in coronary stent therapy, the bioresorbable scaffold (BRS) was rapidly embraced by the interventional cardiologist community due to its potential for long-term benefits and for overcoming limitations inherent to existing drug eluting metallic stents (DES) [1]. BRS were conceived with the concept of offering transient vessel support in that they dissolve after several years. Hereby, they allow and support the restoration of vasomotor function and at the same time facilitate future surgical revascularization [1,2,3]. The most widely investigated poly-L-lactic acid (PLLA) BRS, the Absorb BVS (Abbott Vascular, Santa Clara, CA, USA), was taken from the market. We sought to investigate the acute mechanical performance of Magmaris in comparison with the PLLA-based DESolve BRS (Elixir Medical Corporation, Sunnyvale, CA, USA) in patients who were treated in a real-world scenario. After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced
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