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未经选择使用超薄壁西罗莫司洗脱支架的临床结果:来自瑞典冠状动脉造影和血管成形术登记处(SCAAR)的报告。

Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

机构信息

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

出版信息

EuroIntervention. 2021 Apr 20;16(17):1413-1421. doi: 10.4244/EIJ-D-20-00429.

Abstract

AIMS

The aim of this study was to assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) (Orsiro) in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI).

METHODS AND RESULTS

From the Swedish Coronary Angiography and Angioplasty Registry, the two-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer-generation DES (n-DES group) were analysed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI]: 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% vs 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI: 0.63-1.03, p-value=0.09). The risk of target lesion revascularisation by PCI was lower in the Orsiro group (1.6% vs 2.3%, adjusted HR 0.75, 95% CI: 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI: 0.72-1.35, p-value=0.94; 6.0% vs 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI: 1.00-1.43, p-value=0.06).

CONCLUSIONS

In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favourable clinical outcomes.

摘要

目的

本研究旨在评估在接受经皮冠状动脉介入治疗(PCI)的大型全国性患者队列中,使用西罗莫司洗脱超薄支架药物洗脱支架(DES)(Orsiro)的真实临床效果。

方法和结果

从瑞典冠状动脉血管造影和血管成形术登记处,分析了 4561 名植入 Orsiro(Orsiro 组)和 69570 名接受其他新一代 DES(n-DES 组)的患者的两年结局。两组的明确支架血栓形成率均较低(Orsiro 和 n-DES 分别为 0.67%和 0.83%;调整后的危险比[HR]为 0.90,95%置信区间[CI]:0.55-1.46,p 值为 0.66)。再狭窄也很少见(Orsiro 组为 1.5%,n-DES 组为 2.0%,调整后的 HR 为 0.81,95%CI:0.63-1.03,p 值=0.09)。PCI 靶病变血运重建的风险在 Orsiro 组较低(1.6%比 2.3%,调整后的 HR 为 0.75,95%CI:0.60-0.94,p 值=0.013)。两组之间的全因死亡率和心肌梗死均无统计学差异(两组死亡率均为 7.5%,调整后的 HR 为 0.99,95%CI:0.72-1.35,p 值=0.94;心肌梗死分别为 6.0%和 5.2%,调整后的 HR 为 1.19,95%CI:1.00-1.43,p 值=0.06)。

结论

在全国范围内,使用西罗莫司洗脱超薄支架 DES 预示着良好的临床结局。

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