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Lancet:新型二代药物洗脱可吸收金属支架(DREAM 2G)性能及安全性研究

2015-10-14 fsy 译 MedSci原创

为克服传统非吸收性金属材料制成的药物洗脱支架在某些方面的局限性,可吸收性支架的设计应运而生。目前为止,仅有可吸收性聚合物支架具有商业利用价值。该研究意在对冠状动脉患者使用的新型二代药物洗脱可吸收金属支架(DREAM 2G)的性能以及安全因素进行评估。研究人员在比利时,巴西,丹麦,德国,新加坡,西班牙,瑞士以及荷兰的13所经皮冠状动脉介入治疗中心进行这项具有前瞻性,以及涉及多个(医学或研究)中心特点

为克服传统非吸收性金属材料制成的药物洗脱支架在某些方面的局限性,可吸收性支架的设计应运而生。目前为止,仅有可吸收性聚合物支架具有商业利用价值。该研究意在对冠状动脉患者使用的新型二代药物洗脱可吸收金属支架(DREAM 2G)的性能以及安全因素进行评估。

研究人员在比利时、巴西、丹麦、德国、新加坡、西班牙、瑞士以及荷兰的13所经皮冠状动脉介入治疗中心进行这项具有前瞻性,以及涉及多个(医学或研究)中心特点的试验,且该试验首次以患者作为研究对象。符合条件的患者具有稳定或不稳定的心绞痛,或者有过无症状心肌缺血以及最多两种心源性病变的病历记录。临床随访时间被定在第1、6、12、24以及36个月。患者们在第6个月时进行血管造影随访,同时将患者分成亚组,进行血管内超声,光学相干断层扫描以及血管状况评估等测试。建议所有患者均接受为期至少6个月的双重抗血小板治疗。在6个月后发生晚期管腔丢失时停止治疗。对此研究人员做了意向性分析。

在2013年10月8日至2015年5月22日之间,研究人员共召集123名冠心病患者。6个月时,平均晚期管腔丢失率为0.21mm(SD 0.37),同时对患者采用血管造影术进行观察,发现其中80%的患者存在血管舒缩性发生变化的情况,之后,研究人员对相关结果进行记录。血管超声评估结果显示在支架区域发现少量血管内膜的生成(在6个月时,由6.21mm2[1.22]转变为术后的6.24mm2[SD1.15]),并且光学相关断层扫描结果并未检测出任何腔内肿块。在4例患者中(3%)发现靶向损伤现象:一位患者(1%)死于心源性猝死,一位患者(1%)死于围手术期心肌梗死,另外两位病人需要临床手术对靶向病变血管进行修复。但除此之外,使用新型支架的受试者中并没有发现有血栓形成。

该研究结果显示,6个月时,在原发性冠状动脉病变处置入DREAMS 2G装置具有可行性,改装置具备一定的安全性并能发挥相应的性能。对于阻塞性冠状动脉疾病,可以使用药物吸收式金属支架来代替药物吸收式聚合物支架,进而对该病进行更好的治疗。

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    2016-02-20 gous
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    2016-02-06 howi
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    2015-10-14 zhouxue1990

    支架发展迅速

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