在急性和慢性冠状动脉综合征中最高可生物降解聚合物DES:一项先驱III子研究
Yasin Hussain1, Shigeru Saito2, Michael Curtis3
1Division of Cardiology, Yale School of Medicine, New Haven, Connecticut.
概括
与耐用聚合物常脱支架 (DP-EES) 相比,Supreme DES支架在患有急性冠状动脉综合征 (ACS) 和慢性冠状动脉综合征 (CCS) 的患者中显示出类似的安全性和有效性. 这两种支架类型在12个月后实现了可比的目标损伤失败率.
科学领域:
- 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:
- 先前的PIONEER III试验证实了Supreme DES (可生物降解聚合物,西罗释放支架) 与DP-EES (耐用聚合物,常释放支架) 在12个月后的非劣质性.
- 然而,Supreme DES在不同患者群体的比较安全性和有效性,特别是急性冠状动脉综合征 (ACS) 与慢性冠状动脉综合征 (CCS) 患者的比较安全性和有效性仍未确定.
研究的目的:
- 评估Supreme DES与DP-EES相比在患有ACS和CCS的患者中的相对安全性和有效性.
- 为了分析12个月的目标病变衰竭 (TLF) 率,按临床表现分层.
主要方法:
- 一个前性的,多中心的国际, 2:1随机试验 (PIONEER III) 涉及1628名患者.
- 患者按临床表现分层:ACS (不稳定的心痛,非ST升高的心肌梗塞) 或CCS.
- 主要终点是12个月后的TLF,定义为心脏死亡,目标血管心肌梗塞或缺血驱动的目标病变再血管化的复合.
主要成果:
- 该研究招募了41%的ACS患者和59%的CCS患者. 患有ACS的患者通常年轻,并有较少的并发症,但目前吸烟率较高.
- 在ACS和CCS组之间,12个月的总体TLF率相似 (6.4%对4.4%,P=.1).
- 关键的是,在ACS (6.6%对6.0%,P=.89) 和CCS (4.5%对4.3%,P=.83) 两种人群中,TLF率在Supreme DES和DP-EES之间是可比的,没有显著的相互作用效应 (P=.51).
结论:
- 在患有ACS和CCS的患者中,最高DES的安全性和有效性与DP-EES相提并论.
- 这些发现支持在冠状动脉疾病表现的广泛范围内使用最高DES.
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