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定量血流比评估 BuMA Supreme 可降解聚合物西罗莫司洗脱支架与持久性聚合物佐他莫司洗脱冠状动脉支架的功能比较:PIONEER QFR 亚研究。

Functional comparison between the BuMA Supreme biodegradable polymer sirolimus-eluting stent and a durable polymer zotarolimus-eluting coronary stent using quantitative flow ratio: PIONEER QFR substudy.

机构信息

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

出版信息

EuroIntervention. 2018 Aug 3;14(5):e570-e579. doi: 10.4244/EIJ-D-17-00461.

DOI:10.4244/EIJ-D-17-00461
PMID:28994655
Abstract

AIMS

Quantitative flow ratio (QFR) based on three-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality nine months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES).

METHODS AND RESULTS

The current post hoc analysis was performed in the PIONEER randomised trial (1:1 randomisation to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at preprocedural, post-procedural and nine-month angiography without pharmacologically induced hyperaemia (contrast QFR). At nine months, both the values of QFR distal to the stent (B-SES: 0.89±0.10 vs. R-ZES: 0.89±0.11, p=0.97) and the number of vessels with QFR ≤0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% vs. 3.5%, p=1.00). QFR gradient across the device (∆QFR) at nine months was also similar between the groups (B-SES: 0.03±0.04 vs. R-ZES: 0.03±0.07, p=0.95).

CONCLUSIONS

Quantitative flow assessment nine months after stenting did not differ between B-SES and R-ZES, despite a significant difference in in-stent late lumen loss.

摘要

目的

基于三维定量冠状动脉造影(3D-QCA)的定量血流比(QFR)是评估支架治疗后生理功能的一种新方法。本研究旨在评估植入具有电接枝底层的生物可吸收聚合物西罗莫司洗脱支架(BuMA Supreme:B-SES)与耐用聚合物佐他莫司洗脱支架(Resolute:R-ZES)后九个月的生理功能差异。

方法和结果

本研究为 PIONEER 随机试验的事后分析(1:1 随机分为 B-SES [83 例/95 处病变]和 R-ZES [87 例/101 处病变])。在术前、术后和 9 个月的血管造影时(无药物引起的充血),在支架血管内测量 QFR(对比 QFR)。9 个月时,支架远端 QFR 值(B-SES:0.89±0.10 vs. R-ZES:0.89±0.11,p=0.97)和 QFR≤0.8 的血管数量在两组间无显著差异(11.0% vs. 12.8%,p=0.72),而支架内再狭窄率也相当(3.7% vs. 3.5%,p=1.00)。两组间 9 个月时的支架内 QFR 梯度(∆QFR)也相似(B-SES:0.03±0.04 vs. R-ZES:0.03±0.07,p=0.95)。

结论

尽管支架内晚期管腔丢失存在显著差异,但支架置入 9 个月后,B-SES 和 R-ZES 的定量血流评估无差异。

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