Erbel Raimund, Di Mario Carlo, Bartunek Jozef, Bonnier Johann, de Bruyne Bernard, Eberli Franz R, Erne Paul, Haude Michael, Heublein Bernd, Horrigan Mark, Ilsley Charles, Böse Dirk, Koolen Jacques, Lüscher Thomas F, Weissman Neil, Waksman Ron
West-German Heart Center Essen, Department of Cardiology, Essen, Germany.
Royal Brompton Hospital, Imperial College London, London, UK.
Lancet. 2007 Jun 2;369(9576):1869-1875. doi: 10.1016/S0140-6736(07)60853-8.
Coronary stents improve immediate and late results of balloon angioplasty by tacking up dissections and preventing wall recoil. These goals are achieved within weeks after angioplasty, but with current technology stents permanently remain in the artery, with many limitations including the need for long-term antiplatelet treatment to avoid thrombosis. We report a prospective multicentre clinical trial of coronary implantations of absorbable magnesium stents.
We enrolled 63 patients (44 men; mean age 61.3 [SD 9.5 years]) in eight centres with single de novo lesions in a native coronary artery in a multicentre, non-randomised prospective study. Follow-up included coronary angiography and intravascular ultrasound at 4 months and clinical assessment at 6 months and 12 months. The primary endpoint was cardiac death, non-fatal myocardial infarction, or clinically driven target lesion revascularisation at 4 months
71 stents, 10-15 mm in length and 3.0-3.5 mm in diameter, were successfully implanted after pre-dilatation in 63 patients. Diameter stenosis was reduced from 61.5 (SD 13.1%) to 12.6 (5.6%) with an acute gain of 1.41 mm (0.46 mm) and in-stent late loss of 1.08 mm (0.49 mm). The ischaemia-driven target lesion revascularisation rate was 23.8% after 4 months, and the overall target lesion revascularisation rate was 45% after 1 year. No myocardial infarction, subacute or late thrombosis, or death occurred. Angiography at 4 months showed an increased diameter stenosis of 48.4 (17.0%). After serial intravascular ultrasound examinations, only small remnants of the original struts were visible, well embedded into the intima. Neointimal growth and negative remodelling were the main operating mechanisms of restenosis.
This study shows that biodegradable magnesium stents can achieve an immediate angiographic result similar to the result of other metal stents and can be safely degraded after 4 months. Modifications of stent characteristics with prolonged degradation and drug elution are currently in development.
冠状动脉支架通过固定夹层和防止血管壁回缩来改善球囊血管成形术的近期和远期效果。这些目标在血管成形术后数周内即可实现，但就目前的技术而言，支架会永久性地留在动脉内，存在诸多局限性，包括需要长期进行抗血小板治疗以避免血栓形成。我们报告了一项关于可吸收镁合金支架冠状动脉植入术的前瞻性多中心临床试验。
在一项多中心、非随机前瞻性研究中，我们在8个中心纳入了63例患者（44例男性；平均年龄61.3岁[标准差为9.5岁]），这些患者均有单支冠状动脉的新发病变。随访包括在4个月时进行冠状动脉造影和血管内超声检查，以及在6个月和12个月时进行临床评估。主要终点是4个月时的心脏死亡、非致死性心肌梗死或因临床需要进行的靶病变血管重建。
在63例患者中，经预扩张后成功植入了71枚长度为10 - 15毫米、直径为3.0 - 3.5毫米的支架。直径狭窄率从61.5%（标准差为13.1%）降至12.6%（5.6%），急性增益为1.41毫米（0.46毫米），支架内晚期丢失为1.08毫米（0.49毫米）。4个月后，因缺血驱动的靶病变血管重建率为23.8%，1年后总体靶病变血管重建率为45%。未发生心肌梗死、亚急性或晚期血栓形成或死亡。4个月时的冠状动脉造影显示直径狭窄增加至48.4%（17.0%）。经过系列血管内超声检查，仅可见原始支架的少量残余物，且已很好地嵌入内膜。新生内膜生长和负性重构是再狭窄的主要作用机制。
本研究表明，可生物降解的镁合金支架可取得与其他金属支架相似的即时血管造影效果，且4个月后可安全降解。目前正在研发具有延长降解时间和药物洗脱功能的支架特性改良产品。
