糖尿病患者接受依维莫司洗脱支架和西罗莫司洗脱支架植入后的内膜增生与血管重塑：随机糖尿病与药物洗脱支架（DiabeDES）IV血管内超声试验

Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial.

作者信息

Antonsen Lisbeth, Maeng Michael, Thayssen Per, Christiansen Evald Høj, Hansen Knud Nørregaard, Kaltoft Anne, Hansen Henrik Steen, Thuesen Leif, Lassen Jens Flensted, Jensen Lisette Okkels

机构信息

Department of Cardiology, Odense University Hospital, Odense, Denmark.

出版信息

Catheter Cardiovasc Interv. 2014 May 1;83(6):864-72. doi: 10.1002/ccd.25180. Epub 2013 Sep 30.

DOI:10.1002/ccd.25180

PMID:23996918

Abstract

OBJECTIVE

To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients.

BACKGROUND

Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH).

METHODS

In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume.

RESULTS

Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling.

CONCLUSION

In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling.

摘要

目的

评估依维莫司洗脱Xience™/Promus™支架（EES）和西罗莫司洗脱Cypher™支架（SES）对糖尿病患者内膜增生（IH）的影响。

背景

糖尿病患者因内膜增生（IH），冠状动脉支架植入术后支架内再狭窄风险增加。

方法

在一项经皮冠状动脉介入治疗患者中依维莫司洗脱支架与西罗莫司洗脱支架随机对照研究（SORT OUT IV试验）的子研究中，88例患者有10个月的连续血管内超声（IVUS）随访数据，其中48例接受EES治疗，40例接受SES治疗。IVUS终点包括IH体积、支架内体积阻塞百分比和外弹力膜（EEM）体积变化。

结果

与SES组相比，EES组的IH体积增加[中位数（四分位间距）：2.8 mm³（0.0 - 12.6） vs. 0.0 mm³（0.0 - 1.1），P = 0.001]。与SES相比，EES的支架内体积阻塞百分比增加[中位数（四分位间距）：1.6%（0.0 - 8.2） vs. 0.0%（0.0 - 1.0），P = 0.001]。两组的支架周围外弹力膜（EEM）体积（术后与随访：EES [300 mm³（(219 - 491)） vs. 307 mm³（(223 - 482)），P = 0.73]和SES [316 mm³（(235 - 399)） vs. 323 mm³（(246 - 404)），P = 0.05]）以及支架周围斑块体积（EES [163 mm³（(103 - 273)） vs. 184 mm³（(115 - 291)），P = 0.18]和SES [186 mm³（(139 - 248)） vs. 175 mm³（(153 - 243)），P = 0.26]）均无变化。仅在EES组的近端参考节段可见斑块面积显著增加，且无血管重塑。