Randomized Trial of Optimal Treatment Strategies for In-Stent Restenosis After Drug-Eluting Stent Implantation

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:59

Article

Han, Seungbong²  Seong, In-Whan³  Lee, Nae-Hee⁴  Lee, Bong-Ki⁵  Lee, Keun⁶  Lee, Seung-Wook⁷  Nah, Deuk-Young⁸  Park, Seung-Jung¹ 

[1] Univ Ulsan, Asan Med Ctr, Dept Cardiol, Coll Med,Cardiac Ctr, Seoul 138736, South Korea

[2] Univ Ulsan, Asan Med Ctr, Div Biostat, Coll Med, Seoul 138736, South Korea

[3] Chungnam Natl Univ Hosp, Taejon, South Korea

[4] Soonchunhyang Univ, Bucheon Hosp, Puchon, South Korea

[5] Kangwon Natl Univ Hosp, Chunchon, South Korea

[6] Seoul Vet Hosp, Seoul, South Korea

[7] Kwangju Christian Hosp, Kwangju, South Korea

[8] Donguk Univ Gyeongju Hosp, Gyongju, South Korea

关键词: angioplasty;    coronary disease;    stent;   

DOI  :  10.1016/j.jacc.2011.11.047

来源: Elsevier

【 摘 要 】

Objectives The purpose of this study is to compare the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of restenosis. Background Optimal treatment strategies for ISR within DES have not been adequately addressed yet. Methods Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (<= 10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall 162 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled. Results In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range [IQR]: -0.01 to 0.68 mm vs. 0.06 mm, IQR: -0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: -0.02 to 0.30 mm; vs. 0.00 mm, IQR: -0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between SES group (n = 32) and EES group (n = 34). Conclusions For lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty. For diffuse DES restenosis, implantation of SES or EES is comparably effective in terms of angiographic and clinical outcomes. (J Am Coll Cardiol 2012;59:1093-100) (C) 2012 by the American College of Cardiology Foundation

【 授权许可】

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