前瞻性随机多中心切割球囊血管成形术与金属裸支架试验（REDUCE III）和雷帕霉素洗脱支架评估在鹿特丹心脏病学医院（RESEARCH）研究的定量冠状动脉造影匹配比较。

A quantitative coronary angiography-matched comparison between a prospective randomised multicentre cutting balloon angioplasty and bare metal stent trial (REDUCE III) and the Rapamycin-Eluting Stent Evaluation At Rotterdam Cardiology Hospital (RESEARCH) study.

机构信息

Fujita Health University Hospital, Toyoake, Japan.

出版信息

EuroIntervention. 2010 Aug;6(3):400-6. doi: 10.4244/EIJV6I3A66.

DOI:10.4244/EIJV6I3A66

PMID:20884421

Abstract

AIMS

There remains significant concern about the long-term safety of drug-eluting stents (DES). However, bare metal stents (BMS) have been used safely for over two decades. There is therefore a pressing need to explore alternative strategies for reducing restenosis with BMS. This study was designed to examine whether IVUS-guided cutting balloon angioplasty (CBA) with BMS could convey similar restenosis rates to DES.

METHODS AND RESULTS

In the randomised REstenosis reDUction by Cutting balloon angioplasty Evaluation (REDUCE III) study, 521 patients were divided into four groups based on device and IVUS use before BMS (IVUS-CBA-BMS: 137 patients; Angio-CBA-BMS: 123; IVUS-BA-BMS: 142; and Angio-BA-BMS: 119). At follow-up, the IVUS-CBA-BMS group had a significantly lower restenosis rate (6.6%) than the other groups (p=0.016). We performed a quantitative coronary angiography (QCA) based matched comparison between an IVUS-guided CBA-BMS strategy (REDUCE III) and a DES strategy (Rapamycin-Eluting-Stent Evaluation At Rotterdam Cardiology Hospital, the RESEARCH study). We matched the presence of diabetes, vessel size, and lesion severity by QCA. Restenosis (>50% diameter stenosis at follow-up) and target vessel revascularisation (TVR) were examined. QCA-matched comparison resulted in 120-paired lesions. While acute gain was significantly greater in IVUS-CBA-BMS than DES (1.65±0.41 mm vs. 1.28±0.57 mm, p=0.001), late loss was significantly less with DES than with IVUS-CBA-BMS (0.03±0.42 mm vs. 0.80±0.47 mm, p=0.001). However, no difference was found in restenosis rates (IVUS-CBA-BMS: 6.6% vs. DES: 5.0%, p=0.582) and TVR (6.6% and 6.6%, respectively).

CONCLUSIONS

An IVUS-guided CBA-BMS strategy yielded restenosis rates similar to those achieved by DES and provided an effective alternative to the use of DES.

摘要

目的

药物洗脱支架（DES）的长期安全性仍存在较大顾虑。然而，裸金属支架（BMS）已经安全使用了二十多年。因此，迫切需要探索用 BMS 减少再狭窄的替代策略。本研究旨在探讨血管内超声（IVUS）指导下切割球囊血管成形术（CBA）联合 BMS 是否能达到与 DES 相似的再狭窄率。

方法和结果

在随机的血管内超声指导下切割球囊血管成形术再狭窄减少评估 III 期研究（REstenosis reDUction by Cutting balloon angioplasty Evaluation III，REDUCE III）中，根据 BMS 前的器械和 IVUS 使用情况将 521 例患者分为 4 组（IVUS-CBA-BMS：137 例；Angio-CBA-BMS：123 例；IVUS-BA-BMS：142 例；Angio-BA-BMS：119 例）。随访时，IVUS-CBA-BMS 组的再狭窄率（6.6%）明显低于其他组（p=0.016）。我们对 IVUS 指导下 CBA-BMS 策略（REDUCE III）和 DES 策略（Rapamycin-Eluting-Stent Evaluation At Rotterdam Cardiology Hospital，the RESEARCH 研究）进行了基于定量冠状动脉造影（QCA）的匹配比较。我们通过 QCA 匹配了糖尿病、血管大小和病变严重程度。观察了再狭窄（随访时＞50%的管腔狭窄）和靶血管血运重建（target vessel revascularisation，TVR）。QCA 匹配比较后得到 120 对病变。IVUS-CBA-BMS 的急性获益明显大于 DES（1.65±0.41mm vs. 1.28±0.57mm，p=0.001），而 DES 的晚期丢失明显小于 IVUS-CBA-BMS（0.03±0.42mm vs. 0.80±0.47mm，p=0.001）。然而，两组的再狭窄率（IVUS-CBA-BMS：6.6% vs. DES：5.0%，p=0.582）和 TVR（6.6%和 6.6%）无差异。