Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation

Hae Geun Song; Duk Woo Park; Young Hak Kim; Jung Min Ahn; Won Jang Kim; Jong Young Lee; Soo Jin Kang; Seung Whan Lee; Cheol Whan Lee; Seong Wook Park; Seungbong Han; In Whan Seong; Nae Hee Lee; Bong Ki Lee; Keun Lee; Seung Wook Lee; Deuk Young Nah; Seung Jung Park

doi:10.1016/j.jacc.2011.11.047

Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation

Hae Geun Song, Duk Woo Park, Young Hak Kim, Jung Min Ahn, Won Jang Kim, Jong Young Lee, Soo Jin Kang, Seung Whan Lee, Cheol Whan Lee, Seong Wook Park, Seungbong Han, In Whan Seong, Nae Hee Lee, Bong Ki Lee, Keun Lee, Seung Wook Lee, Deuk Young Nah, Seung Jung Park

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Abstract

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.

Original language	English
Pages (from-to)	1093-1100
Number of pages	8
Journal	Journal of the American College of Cardiology
Volume	59
Issue number	12
DOIs	https://doi.org/10.1016/j.jacc.2011.11.047
State	Published - 20 Mar 2012
Externally published	Yes

Keywords

angioplasty
coronary disease
stent

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10.1016/j.jacc.2011.11.047

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Song, H. G., Park, D. W., Kim, Y. H., Ahn, J. M., Kim, W. J., Lee, J. Y., Kang, S. J., Lee, S. W., Lee, C. W., Park, S. W., Han, S., Seong, I. W., Lee, N. H., Lee, B. K., Lee, K., Lee, S. W., Nah, D. Y., & Park, S. J. (2012). Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation. Journal of the American College of Cardiology, 59(12), 1093-1100. https://doi.org/10.1016/j.jacc.2011.11.047

@article{698e44df09554b31a3985e573eaf5844,

title = "Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation",

abstract = "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.",

keywords = "angioplasty, coronary disease, stent",

author = "Song, \{Hae Geun\} and Park, \{Duk Woo\} and Kim, \{Young Hak\} and Ahn, \{Jung Min\} and Kim, \{Won Jang\} and Lee, \{Jong Young\} and Kang, \{Soo Jin\} and Lee, \{Seung Whan\} and Lee, \{Cheol Whan\} and Park, \{Seong Wook\} and Seungbong Han and Seong, \{In Whan\} and Lee, \{Nae Hee\} and Lee, \{Bong Ki\} and Keun Lee and Lee, \{Seung Wook\} and Nah, \{Deuk Young\} and Park, \{Seung Jung\}",

year = "2012",

month = mar,

day = "20",

doi = "10.1016/j.jacc.2011.11.047",

language = "English",

volume = "59",

pages = "1093--1100",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "12",

}

Song, HG, Park, DW, Kim, YH, Ahn, JM, Kim, WJ, Lee, JY, Kang, SJ, Lee, SW, Lee, CW, Park, SW, Han, S, Seong, IW, Lee, NH, Lee, BK, Lee, K, Lee, SW, Nah, DY & Park, SJ 2012, 'Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation', Journal of the American College of Cardiology, vol. 59, no. 12, pp. 1093-1100. https://doi.org/10.1016/j.jacc.2011.11.047

TY - JOUR

T1 - Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation

AU - Song, Hae Geun

AU - Park, Duk Woo

AU - Kim, Young Hak

AU - Ahn, Jung Min

AU - Kim, Won Jang

AU - Lee, Jong Young

AU - Kang, Soo Jin

AU - Lee, Seung Whan

AU - Lee, Cheol Whan

AU - Park, Seong Wook

AU - Han, Seungbong

AU - Seong, In Whan

AU - Lee, Nae Hee

AU - Lee, Bong Ki

AU - Lee, Keun

AU - Lee, Seung Wook

AU - Nah, Deuk Young

AU - Park, Seung Jung

PY - 2012/3/20

Y1 - 2012/3/20

N2 - 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.

AB - 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.

KW - angioplasty

KW - coronary disease

KW - stent

UR - https://www.scopus.com/pages/publications/84863234747

U2 - 10.1016/j.jacc.2011.11.047

DO - 10.1016/j.jacc.2011.11.047

M3 - Article

C2 - 22421303

AN - SCOPUS:84863234747

SN - 0735-1097

VL - 59

SP - 1093

EP - 1100

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 12

ER -

Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation

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