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非聚合物基的帕克利塔塞尔涂层冠状动脉支架用于治疗新冠状动脉病变患者:DELIVER临床试验的血管学随访.

Alexandra J Lansky1, Ricardo A Costa, Gary S Mintz

  • 1Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, 55 E 59th St, 6th Floor, New York, NY 10022-1112, USA. alansky@crf.org

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概括

与冠状动脉疾病中的ML PENTA支架相比,ACHIEVE帕克利塔塞尔涂层支架降低了新极限增殖,但并没有显著降低目标血管衰竭或二进制缩.

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科学领域:

  • 心血管医学 心血管医学
  • 干预心脏病学 干预心脏病学
  • 生物材料科学 生物材料科学

背景情况:

  • 帕克利塔塞尔是一种强大的抗瘤化合物,可以抑制平滑肌肉细胞的增殖.
  • 在DELIVER试验中,评估了ACHIEVE包利塔塞尔涂层支架与ML PENTA支架的对比.

研究的目的:

  • 评估ACHIEVE支架在减少目标血管衰竭和二进制静脉复缩方面的有效性.
  • 为了比较非聚合物基的帕克利塔塞尔涂层支架与裸金属支架的性能.

主要方法:

  • 一个前性的,随机的,盲目的,多中心试验,涉及1043名冠状动脉病变患者.
  • 随机选择使用ACHIEVE支架 (n=524) 或ML PENTA支架 (n=519).
  • 主要终点的评估:目标血管衰竭减少40%,双重复缩减50%.

主要成果:

  • 随着ACHIEVE (0.81毫米) 与ML PENTA (0.98毫米;P=0.003) 的使用,支架延迟损失显著降低.
  • 二进制缩率为ACHIEVE的14.9%,ML PENTA的20.6% (P=0.076). 这两种药物的使用率是相同的.
  • 目标船的故障率为ACHIEVE的11.9%,ML PENTA的14.5% (P=0.12). 目标船的故障率为ACHIEVE的11.9%,ML PENTA的14.5% (P=0.12). 目标船的故障率为ACHIEVE的11.9%,ML PENTA的14.5% (P=0.12).

结论:

  • 与赤裸金属PENTA支架相比,ACHIEVE包利塔塞尔涂层支架显示了降低的新极限增殖.
  • 这种减少不足以达到主要临床终点的目标血管衰竭或二次终点的二进制复原.