Waksman Ron, Pakala Rajbabu, Kuchulakanti Pramod K, Baffour Richard, Hellinga David, Seabron Rufus, Tio Fermin O, Wittchow Eric, Hartwig Sonja, Harder Claus, Rohde Roland, Heublein Bernd, Andreae Arnim, Waldmann Karl-Heinz, Haverich Axel
Cardiovascular Research Institute, Washington Hospital Center, Washington, DC 20010, USA.
Catheter Cardiovasc Interv. 2006 Oct;68(4):607-17; discussion 618-9. doi: 10.1002/ccd.20727.
We aimed to determine the safety and efficacy of biobasorbable magnesium alloy stents in porcine coronary arteries. Bioabsorbable magnesium stents carry the potential to overcome the limitations posed by permanent metallic stents such as chronic inflammation, late stent thrombosis, prolonged antiplatelet therapy, and artifacts when imaged by multislice-computed tomography or magnetic resonance imaging.
Magnesium alloy stents or stainless steel stents were randomly deployed in coronary arteries of domestic or minipigs. Domestic pigs were sacrificed at 3 days (n = 2) or 28 days, and minipigs at 3 months.
At 3 days, magnesium alloy stents were intact, but started to show signs of degradation by 28 days. There was no evidence of stent particle embolization, thrombosis, excess inflammation, or fibrin deposition. At 28 days and 3 months, neointimal area was significantly less in magnesium alloy stent segments (2.44 +/- 0.88 mm(2) and 1.16 +/- 0.19 mm(2)) as compared with the stainless steel stent segments (5.03 +/- 1.5 mm(2) and 1.72 +/- 0.68 mm(2), P < 0.001 and 0.02). Quantitative coronary analysis indicates that percentage area stenosis and percentage diameter stenosis in magnesium alloy stent segments improved significantly at 3 months as compared to 28 days. Despite decreased neointimal hyperplasia, lumen area of the magnesium alloy stented vessels did not improve significantly.
Magnesium alloy stents are safe and are associated with less neointima formation; however, reduced neointima did not result in larger lumen.
我们旨在确定生物可吸收镁合金支架在猪冠状动脉中的安全性和有效性。生物可吸收镁支架有可能克服永久性金属支架带来的局限性，如慢性炎症、晚期支架血栓形成、长期抗血小板治疗以及多层计算机断层扫描或磁共振成像时出现的伪影。
将镁合金支架或不锈钢支架随机植入家猪或小型猪的冠状动脉中。家猪在3天（n = 2）或28天时处死，小型猪在3个月时处死。
在3天时，镁合金支架完好无损，但到28天时开始出现降解迹象。没有证据表明存在支架颗粒栓塞、血栓形成、过度炎症或纤维蛋白沉积。在28天和3个月时，与不锈钢支架段（5.03 +/- 1.5 mm(2) 和1.72 +/- 0.68 mm(2)，P < 0.001和0.02）相比，镁合金支架段的新生内膜面积显著更小（2.44 +/- 0.88 mm(2) 和1.16 +/- 0.19 mm(2)）。定量冠状动脉分析表明，与28天时相比，镁合金支架段在3个月时的面积狭窄百分比和直径狭窄百分比有显著改善。尽管新生内膜增生减少，但镁合金支架植入血管的管腔面积并未显著改善。
镁合金支架是安全的，且与较少的新生内膜形成相关；然而，新生内膜减少并未导致更大的管腔。
