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Lancet:依维莫司洗脱生物可吸收血管支架优势并不明显

2015-11-17 崔倩 译 MedSci原创

生物可吸收冠脉支架可能会改善经皮冠状动脉介入治疗的患者预后。

生物可吸收冠脉支架可能会改善经皮冠状动脉介入治疗的患者预后。这些支架中依维莫司洗脱生物可吸收血管支架被研究得最多;然而,它的性能与依维莫司洗脱金属支架仍然不好界定。该研究的目的是评估依维莫司洗脱生物可吸收的血管支架 vs 依维莫司洗脱金属支架对于经皮血管形成术治疗缺血性心脏疾病患者的疗效性和安全性。

研究人员检索了Medline、Embase、ochrane对照试验注册中心(CENTRAL)、科学会议摘要和相关网站的随机试验调查依维莫司洗脱生物可吸收血管支架 vs 依维莫司洗脱金属支架的效果,这些研究都是在2006年11月30日和2015年10月12日之间发表的,主要疗效终点为靶病变血运重建,主要安全性结果为确诊或可能的支架(支架)血栓形成。次要终点为靶病变失败(心源性死亡,靶血管心肌梗死或缺血导致的靶病变血运重建复合结果)、心肌梗死、死亡、以及设备晚期管腔丢失。研究人员得出的比值比(OR)和加权平均差异的95%可信区间,并按照随机效应模型计算的风险估计的主要成果。

该研究共包括6项试验,共包括3738例随机接受经皮冠状动脉介入治疗患者的数据,使用依维莫司洗脱生物可吸收血管支架(n =2337)或依维莫司洗脱金属支架(n=1401)。中位随访期为12个月(IQR 9-12)。与金属支架治疗患者相比,用生物可吸收血管支架治疗的患者有类似的靶病变血运重建(OR 0.97 [95%Cl 0.66-1.43];P=0.87),靶病变失败(1.20[0.90-1.60];p=0.21),心肌梗死(1.36[0.98-1.89];p=0.06)和死亡(0.95[0.45-2.00];P=0.89)的风险。生物可吸收血管支架治疗的患者支架血栓的风险比那些用金属支架治疗明确或可能高(OR 1.99 [95%Cl 1.00-3.98];P=0.05),植入后1到30天之间的风险最高(3.11 [1.24-7.82];p=0.02)。用生物可吸收血管支架治疗的病变比那些用金属支架治疗患者有较大的设备晚期管腔损失(加权平均差异0.08 [95%Cl 0.05-0.12];P<0.000)。

与依维莫司洗脱金属支架相比,依维莫司洗脱生物可吸收血管支架在1年的随访中的重复血运重建率相似,尽管中期血管造影表现稍差。然而,使用生物可吸收血管支架治疗的患者亚急性支架内血栓形成的风险增加。未来还需要在大量患者中延长随访时间充分评估依维莫司洗脱生物可吸收血管支架的长期优势。

原始出处:

Salvatore Cassese,Robert A Byrne,Gjin Ndrepepa,et al.Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents,Lancet,2015.11.16

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    2016-10-17 howi
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