Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry
Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry
复制标题
DOI：
10.4244/eijy14m07_11
复制
发表时间：
2015-02-01
期刊：
影响因子：
6.2
通讯作者：
Tamburino, Corrado
中科院分区：
文献类型：
--
作者：
Capodanno, Davide;Gori, Tommaso;Tamburino, Corrado
目的：关于生物可吸收血管支架(BVS)在常规临床实践中的早期和中期结果的临床数据有限。为了填补这一空白，我们报告了来自大型多中心GHOST-EU登记的维罗莫司洗脱BVS的经皮冠状动脉介入治疗的早期和中期临床结果。方法和结果：2011年11月至2014年1月，1,189名患者在10个欧洲中心接受了一种或多种BVS的经皮冠状动脉介入治疗(吸收BVS；雅培血管，圣克拉拉，美国，美国)。令人感兴趣的主要结果是靶病变失败(TLF)，定义为心脏死亡、靶血管心肌梗死或临床驱动的靶病变血运重建(TLR)的组合。在平均12.3+/-3.4atm处植入了1,731个吸收BV。99.7%的病例获得了技术成功。在1189名患者中，67名患者在植入后中位数109天(四分位数范围8-227天)记录到了TLF。TLF累积发生率30天为2.2%，6个月为4.4%。TLF的年化增长率为10.1%。6个月时，心源性死亡的发生率为1.0%，靶血管心肌梗死的发生率为2.0%，TLR为2.5%，靶血管再血管化的发生率为4.0%。糖尿病是唯一的独立预测因素(危险比2.41，95%可信区间：1.28-4.53；p=0.006)。明确/可能支架血栓的累积发生率在30天时为1.5%，在6个月时为2.1%，23例中有16例发生在30天内。结论：BVS在6个月时的TLF发生率是可以接受的，尽管早期和中期支架血栓的发生率不可忽视，大多数聚集在30天内。
Aims: Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry.Methods and results: Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3 +/- 3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days.Conclusions: "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.