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支架血栓形成:来自 SPIRIT II、SPIRIT III、SPIRIT IV 和 COMPARE 试验的关于双抗血小板治疗中断的结局、预测因素和影响的见解。

Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials.

机构信息

Maasstad Ziekenhuis, Rotterdam, The Netherlands.

出版信息

EuroIntervention. 2012 Sep;8(5):599-606. doi: 10.4244/EIJV8I5A92.

Abstract

AIMS

Recent studies have suggested that EES may reduce ST compared to PES, but no individual trial has been adequately powered for this endpoint. The incidence of stent thrombosis, as well as the impact of dual antiplatelet therapy (DAPT) discontinuation during the first two years following everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) deployment were therefore analysed from a pooled, patient-level database derived from four randomised clinical trials.

METHODS AND RESULTS

Data from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials (n=6,789 patients) were analysed. Two-year ST rates were determined using time-to-event methods and compared with the log-rank test. ST rates were also determined after DAPT discontinuation. EES compared to PES significantly reduced the two-year rates of ST (0.7% versus 2.3%, p=0.0001), including the interval rates of ST up to 30 days (0.2% versus 1.0%, p<0.0001), between 31 days and one year (0.2% versus 0.6%, p=0.02), and after one year (0.3% versus 0.8%, p=0.001). EES also reduced the two-year composite rate of cardiac death or MI (4.0% versus 6.6%, p=0.0001). Increased rates of ST after DAPT discontinuation beyond six months were observed in the PES cohort, but not in the EES cohort.

CONCLUSION

In this large pooled analysis from four randomised trials, treatment with EES compared to PES significantly reduced the rates of ST through two years of follow-up, with a concomitant reduction in cardiac death or MI. DAPT discontinuation beyond six months may be safe with EES.

摘要

目的

最近的研究表明,与 PES 相比,EES 可能会降低 ST,但没有一项单独的试验对此终点有足够的效力。因此,从四项随机临床试验的汇总患者水平数据库中分析了依维莫司洗脱支架(EES)和紫杉醇洗脱支架(PES)植入后两年内支架血栓形成的发生率,以及双联抗血小板治疗(DAPT)停药的影响。

方法和结果

分析了 SPIRIT II、SPIRIT III、SPIRIT IV 和 COMPARE 试验的数据(n=6789 例患者)。使用时间事件方法确定两年 ST 率,并与对数秩检验进行比较。还在 DAPT 停药后确定 ST 率。与 PES 相比,EES 显著降低了两年 ST 率(0.7%比 2.3%,p=0.0001),包括 ST 发生率的 30 天间隔期(0.2%比 1.0%,p<0.0001)、31 天至一年(0.2%比 0.6%,p=0.02)和一年后(0.3%比 0.8%,p=0.001)。EES 还降低了两年复合终点的心脏死亡或心肌梗死率(4.0%比 6.6%,p=0.0001)。在 PES 队列中观察到 DAPT 停药超过六个月后 ST 发生率增加,但在 EES 队列中未观察到。

结论

在四项随机试验的这项大型汇总分析中,与 PES 相比,EES 治疗在两年随访期间显著降低了 ST 发生率,同时降低了心脏死亡或心肌梗死的发生率。EES 停药超过六个月可能是安全的。

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