Optical coherence tomography study of healing characteristics of paclitaxel-eluting balloons vs. everolimus-eluting stents for in-stent restenosis: the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) randomised clinical trial

被引：66

作者：

Adriaenssens, Tom ^{[1
,2
]}

Dens, Jo ^{[3
]}

Ughi, Giovanni ^{[1
,2
]}

Bennett, Johan ^{[1
,2
]}

Dubois, Christophe ^{[1
,2
]}

Sinnaeve, Peter ^{[1
,2
]}

Wiyono, Stefanus ^{[1
,2
]}

Coosemans, Mark ^{[1
,2
]}

Belmans, Ann ^{[1
,2
]}

D'hooge, Jan ^{[1
,2
]}

Vrolix, Mathias ^{[3
]}

Desmet, Walter ^{[1
,2
]}

机构：

[1] Katholieke Univ Leuven, Dept Cardiovasc Dis, Univ Hosp Leuven, Leuven, Belgium

[2] Katholieke Univ Leuven, Dept Cardiovasc Sci, Leuven, Belgium

[3] ZOL Hosp Genk, Genk, Belgium

来源：

EUROINTERVENTION | 2014年 / 10卷 / 04期

关键词：

drug-eluting balloon; drug-eluting stent; in-stent restenosis; optical coherence tomography; percutaneous coronary intervention; stent coverage; BARE-METAL STENTS; COATED BALLOON; FOLLOW-UP; VASCULAR BRACHYTHERAPY; MYOCARDIAL-INFARCTION; NEOINTIMAL COVERAGE; ANGIOPLASTY; NEOATHEROSCLEROSIS; ANGIOGRAPHY; PREVENTION;

D O I：

10.4244/EIJV10I4A77

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aims: Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons (DEB) and the second generation of drug-eluting stents (DES) when used to treat in-stent restenosis (ISR). In this study, we set out to compare prospectively the healing characteristics, as assessed by optical coherence tomography (OCT), of DEB versus DES after treatment of ISR in bare metal stents (BMS). Methods and results: Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent (EES). The primary endpoint was the percentage of uncovered struts, assessed with OCT at nine months, as a marker of vessel wall healing. A mean of 366 +/- 135 and 636 +/- 184 struts were analysed per patient in the DEB and EES groups, respectively. The percentage of uncovered struts per patient was significantly lower with DEB vs. EES (1.4% vs. 3.1%, p=0.025). Mean neointimal hyperplasia area was 2.4 +/- 1.08 mm(2) in DEB vs. 1.92 +/- 0.67 mm(2) in EES (p=0.1806), while the percentage of malapposed struts per patient was very low in both groups (0.2% vs. 0.3%, p=0.699). At nine months, angiographic in-stent MLD (minimum lumen diameter) was lower (2.13 vs. 2.54 mm, p=0.006), while diameter stenosis (26.4 vs. 11.4%, p=0.002), and LLL (0.28 vs. 0.07 mm, p=0.1) were higher after DEB compared to EES. During one-year follow-up, we did not observe differences in the rates of death, TLR (target lesion revascularisation) or stent thrombosis. Conclusions: DEB appears to be associated with better healing characteristics, as assessed by stent strut coverage with OCT, but tended to be slightly less effective compared to EES. These findings give support to the use of either DEB or EES as valuable treatment options for ISR.

引用

页码：439 / 448

页数：10

共 34 条

[21] Hotlines and clinical trial updates presented at the German Cardiac Society Meeting 2010: FAIR-HF, CIPAMI, LIPSIA-NSTEMI, Handheld-BNP, PEPCAD III, remote ischaemic conditioning, CERTIFY, PreSCD-II, German Myocardial Infarction Registry, DiaRegis [J].