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COMBO 支架与 Resolute Integrity 和 PROMUS Element 支架经皮冠状动脉介入治疗后的临床结局:倾向评分匹配分析。

Clinical outcomes after percutaneous coronary intervention with the COMBO stent versus Resolute Integrity and PROMUS Element stents: a propensity-matched analysis.

机构信息

Academic Medical Center - University of Amsterdam, Amsterdam, the Netherlands.

出版信息

EuroIntervention. 2017 Nov 20;13(10):1202-1209. doi: 10.4244/EIJ-D-17-00301.

Abstract

AIMS

The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.

METHODS AND RESULTS

Patients from the REMEDEE registry (COMBO, n=1,000) were matched with patients from the DUTCH PEERS trial (PROMUS Element/Resolute Integrity, n=1,811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79).

CONCLUSIONS

In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

摘要

目的

COMBO 支架将西罗莫司洗脱与内皮祖细胞捕获层相结合,以促进早期内皮化。尚未将这种新型设备与任何其他目前使用的药物洗脱支架(DES)进行头对头比较。我们旨在比较 COMBO 支架置入后两年时 COMBO 支架与 Resolute Integrity 或 PROMUS Element 支架在所有患者中的临床结果。

方法和结果

REMEDEE 登记处(COMBO,n=1000)的患者与 DUTCH PEERS 试验(PROMUS Element/Resolute Integrity,n=1811)的患者进行了匹配。应用 13 项基线特征的倾向评分匹配来创建接受 COMBO 与 PROMUS Element/Resolute Integrity 治疗的两组平衡患者队列。倾向评分匹配产生了 771 对患者,代表了所有患者,中位年龄为 65 岁,27%为女性,超过 50%的患者患有急性冠状动脉综合征。两年随访时,COMBO 组的靶病变失败(TLF),即心脏死亡、靶血管心肌梗死和任何靶病变血运重建的复合终点为 7.9%,PROMUS Element/Resolute Integrity 组为 6.4%,HR 为 1.24(95%CI:0.85-1.81),p=0.26。两组之间明确的支架血栓形成(ST)无显著差异(0.8%比 0.9%,p=0.79)。

结论

在倾向评分匹配分析中,COMBO 支架与 Resolute Integrity 和 PROMUS Element 相比,在两年随访时 TLF 和 ST 的发生率相似。

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