生物降解的聚合物生物排泄支架与耐用的聚合物常排泄支架 (COMPARE II):一个随机的,受控的,非劣等性试验
Pieter Cornelis Smits1, Sjoerd Hofma, Mario Togni
1Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, Netherlands. smitsp@maasstadziekenhuis.nl
Lancet (London, England)
|February 5, 2013
概括
可生物降解的聚合物生物排泄支架在接受皮肤冠状动脉干预的患者中显示出与耐用聚合物恒排泄支架相比的安全性和有效性. 需要进行更长的随访,以评估长期的支架血栓形成风险.
科学领域:
- 心脏病学 心脏病学
- 生物医学工程 生物医学工程
- 干预心脏病学 干预心脏病学
背景情况:
- 药物排泄支架 (DES) 减轻了早期代人所见的血栓形成风险.
- 生物降解和耐用的聚合物被用于现代的DES.
- 比较可生物降解聚合物生物排泄支架 (BP-BES) 与耐用聚合物常排泄支架 (DP-EES) 是至关重要的.
研究的目的:
- 为了比较BP-BES与DP-EES的安全性和有效性.
- 为了评估心脏死亡,心肌梗塞或12个月后目标血管再血管化的初级终点.
主要方法:
- 在12个欧洲地区进行的开放标签,前性,随机化,受控的非劣势试验.
- 2707名冠状动脉疾病患者被随机分配 (2:1) 给BP-BES (Nobori) 或DP-EES (Xience/Promus).
- 通过治疗意图分析的主要终点;患者接受了12个月的双重抗血小板治疗.
主要成果:
- 主要终点发生在5.2%的BP-BES患者和4.8%的DP-EES患者中 (RR 1.07,95%CI 0.75-1.52).
- 实现了非劣质性 (p<0.0001).
- 在BP-BES组中,更多患者接受了未分配的支架 (5.9%对2.1%,p<0.0001).
结论:
- 可生物降解的聚合物生物排泄支架在安全性和有效性方面与耐用聚合物生物排泄支架在12个月后没有劣势.
- 需要进行更长期的随访,以确定BP-BES是否可以降低1年后的支架血栓形成风险.
- 这项研究支持BP-BES作为当前DP-EES标准的可行替代方案.
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