随机比较新型低剂量西罗利斯-化生物降解聚合物支架与第二代DES:TARGET-IV NA试验
Robert W Yeh1, Olivier F Bertrand2, Ehtisham Mahmud3
1Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA; Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Journal of the American College of Cardiology
|October 31, 2024
概括
在12个月的时间里,Firehawk生物降解聚合物西罗脱支架 (BP-SES) 在预防目标病变失败方面表现出与第二代药物脱支架 (DESs) 相比的非劣势. 这项研究证实BP-SES是冠状动脉干预的安全有效选择.
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:
- 药物排泄支架 (DESs) 降低了复缩,但耐用聚合物可以阻碍愈合.
- 防火生物降解聚合物西罗脱支架 (BP-SES) 具有局部化,生物降解的聚合物涂层,具有较低的药物剂量.
研究的目的:
- 在北美和欧洲试验中,比较BP-SES与第二代DES的临床结果.
- 评估BP-SES在预防目标病变衰竭 (TLF) 中的非劣势性.
主要方法:
- 一个前性的,多中心的,单盲的, 1:1随机的非劣势性试验 (TARGET-IV NA).
- 1720名冠状动脉综合征患者被随机分配到BP-SES或对照DES.
- 主要终点:12个月的TLF;二次终点包括静脉内晚期光量损失和新极端增生.
主要成果:
- 在12个月后,BP-SES对TLF的DES控制器 (3.4%对3.3%) 没有劣势.
- 与对照组相比,BP-SES的平均静脉晚期光量损失显著低于BP-SES (P<0.0001).
- 两组之间没有观察到新极度增生症厚度的显著差异.
结论:
- 可生物降解的聚合物西洛利木斯排泄支架 (BP-SES) 与第二代DES相比,符合TLF的非劣质标准.
- 对于穿皮冠状动脉干预,BP-SES提供了有利的安全性和有效性概况.
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