Ann Intern Med:生物可吸收支架安全性堪忧!增加支架血栓和心梗风险

2017-10-20 朱柳媛 中国循环杂志

10月17日,南京大学医学院附属鼓楼医院心内科徐标教授团队在《内科学年鉴》杂志发表的一项系统综述和Meta分析表明,依维莫司生物可吸收支架(BVS)有增加支架内血栓形成和其他血栓栓塞事件的风险,且风险随着时间延长而增加。研究者指出,“BVS需要优化支架相关技术以及支架设计,以改善其临床结局。”

今年9月8日,雅培公司宣布,在全球各国停止销售该公司生产的第一代生物可吸收支架,原因为“销售量低”,在全球范围内Absorb的销售额不足雅培所有支架销售额的1%。

实际上,生物可吸收支架的问题可能不仅仅是销售量低,其安全性备受业界关注。

今年3月,美国食品药品监督管理局(FDA)就以信件的形式告知医疗工作者生物可吸收支架潜在的安全性问题。

10月17日,南京大学医学院附属鼓楼医院心内科徐标教授团队在《内科学年鉴》杂志发表的一项系统综述和Meta分析表明,依维莫司生物可吸收支架(BVS)有增加支架内血栓形成和其他血栓栓塞事件的风险,且风险随着时间延长而增加。

研究者指出,“BVS需要优化支架相关技术以及支架设计,以改善其临床结局。

数据显示,中位随访1年时,置入BVS的患者中确定或极可能的支架内血栓形成发生率为1.8%,中位随访1年以上时发生率为0.8%。

中位随访25个月时,与置入依维莫司金属支架(EES)的患者相比,置入BVS的患者出现确定或极可能的支架内血栓形成的风险会增加2.4倍。

置入BVS的患者无论早期还是晚期或极晚期,支架内血栓形成的风险都显着增加,而且,1年后的风险几乎是1年内的2倍。

此外,BVS还显着增加心肌梗死(OR=1.63)、靶病变血运重建(OR=1.31)、靶病变失败(OR=1.37)的发生风险。这3个终点事件的发生风险也随时间延长而升高。

在死亡(包括全因死亡、心原性和非心原性死亡)、靶血管血运重建和任何重建事件上,EES组和BVS组发生率相似。

研究人员对7项随机对照试验和38项相关观察性研究的数据进行了分析。

原始出处:


2 Sanket S. Curtis. Requiem for a Scaffold. Ann Intern Med. 17October 2017.

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    2017-10-22 仁心济世
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    2017-10-20 戒馋,懒,贪

    谢谢分享

    0

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    2017-10-20 天涯183

    非常好的文章.学习了

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