Boeder Niklas F, Dörr Oliver, Koepp Tim, Blachutzik Florian, Achenbach Stephan, Elsässer Albrecht, Hamm Christian W, Nef Holger M
Medical Clinic I, University Hospital of Giessen, Giessen, Germany.
Medical Clinic 2, University Hospital of Erlangen, Erlangen, Germany.
Front Cardiovasc Med. 2021 Jun 14;8:696287. doi: 10.3389/fcvm.2021.696287. eCollection 2021.
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. 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). 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 ( = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS ( < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm; < 0.001). 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.
在基于聚左旋乳酸（PLLA）的生物可吸收血管支架（Absorb BVS）因其高不良事件发生率而退市后，一种镁基支架（Magmaris）被引入。为了使用光学相干断层扫描（OCT）在合适的支架展开方面比较西罗莫司洗脱镁合金Magmaris支架与诺伐他汀洗脱PLLA基DESolve支架的急性性能。纳入了98例患者最终OCT回撤的数据（19例Magmaris，79例DESolve）并以1毫米间隔进行分析。计算了以下指标：平均面积和最小面积、残余面积狭窄、支柱贴壁不全、组织脱垂、偏心指数、对称指数、支柱断裂和边缘夹层。OCT显示Magmaris与DESolve的最小管腔面积分别为6.6±1.6和6.0±1.9（P = 0.06）。残余面积狭窄>20%的支架主要见于DESolve组（15.8%对46.8%；P = 0.01）。平均偏心指数确实有显著差异（0.74±0.06对0.63±0.09；P < 0.001）。未观察到Magmaris支架有断裂，但DESolve生物可吸收支架（BRS）有15.2%记录有断裂（P < 0.001）。DESolve组的支架贴壁不全面积显著更高（0.01±0.02对1.05±2.32平方毫米；P < 0.001）。这是第一项在真实世界环境中比较Magmaris和DESolve急性机械性能的研究。Magmaris生物可吸收支架的急性机械性能似乎优于DESolve生物可吸收支架，而根据普遍接受的成像标准，OCT显示两种生物可吸收支架的急性机械性能都良好。
