Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial

Kyung Woo Park; In Ho Chae; Do Sun Lim; Kyoo Rok Han; Han Mo Yang; Hae Young Lee; Hyun Jae Kang; Bon Kwon Koo; Taehoon Ahn; Jung Han Yoon; Myung Ho Jeong; Taek Jong Hong; Woo Young Chung; Sang Ho Jo; Young Jin Choi; Seung Ho Hur; Hyuck Moon Kwon; Dong Woon Jeon; Byung Ok Kim; Si Hoon Park; Nam Ho Lee; Hui Kyung Jeon; Hyeon Cheol Gwon; Yang Soo Jang; Hyo Soo Kim

doi:10.1016/j.jacc.2011.07.031

Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial

Kyung Woo Park, In Ho Chae, Do Sun Lim, Kyoo Rok Han, Han Mo Yang, Hae Young Lee, Hyun Jae Kang, Bon Kwon Koo, Taehoon Ahn, Jung Han Yoon, Myung Ho Jeong, Taek Jong Hong, Woo Young Chung, Sang Ho Jo, Young Jin Choi, Seung Ho Hur, Hyuck Moon Kwon, Dong Woon Jeon, Byung Ok Kim, Si Hoon ParkNam Ho Lee, Hui Kyung Jeon, Hyeon Cheol Gwon, Yang Soo Jang, Hyo Soo Kim

Research output: Contribution to journal › Article › peer-review

124 Citations (Scopus)

Abstract

Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)

Original language	English
Pages (from-to)	1844-1854
Number of pages	11
Journal	Journal of the American College of Cardiology
Volume	58
Issue number	18
DOIs	https://doi.org/10.1016/j.jacc.2011.07.031
Publication status	Published - 2011 Oct 25

Bibliographical note

Funding Information:
This study was supported by a grant from the Clinical Research Center for Ischemic Heart Disease , Seoul, Republic of Korea ( 0412-CR02-0704-0001 ), and a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( A062260 ), sponsored by the Ministry of Health, Welfare & Family, Republic of Korea. The authors also received unrestricted grants from Abbott Vascular Korea and Boston Scientific Korea . The funding source of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the manuscript. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

All Science Journal Classification (ASJC) codes

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2011.07.031

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Park, K. W., Chae, I. H., Lim, D. S., Han, K. R., Yang, H. M., Lee, H. Y., Kang, H. J., Koo, B. K., Ahn, T., Yoon, J. H., Jeong, M. H., Hong, T. J., Chung, W. Y., Jo, S. H., Choi, Y. J., Hur, S. H., Kwon, H. M., Jeon, D. W., Kim, B. O., ... Kim, H. S. (2011). Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial. Journal of the American College of Cardiology, 58(18), 1844-1854. https://doi.org/10.1016/j.jacc.2011.07.031

@article{c09f25f1d62a4bac870b52f1c76c2aef,

title = "Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial",

abstract = "Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)",

author = "Park, {Kyung Woo} and Chae, {In Ho} and Lim, {Do Sun} and Han, {Kyoo Rok} and Yang, {Han Mo} and Lee, {Hae Young} and Kang, {Hyun Jae} and Koo, {Bon Kwon} and Taehoon Ahn and Yoon, {Jung Han} and Jeong, {Myung Ho} and Hong, {Taek Jong} and Chung, {Woo Young} and Jo, {Sang Ho} and Choi, {Young Jin} and Hur, {Seung Ho} and Kwon, {Hyuck Moon} and Jeon, {Dong Woon} and Kim, {Byung Ok} and Park, {Si Hoon} and Lee, {Nam Ho} and Jeon, {Hui Kyung} and Gwon, {Hyeon Cheol} and Jang, {Yang Soo} and Kim, {Hyo Soo}",

note = "Funding Information: This study was supported by a grant from the Clinical Research Center for Ischemic Heart Disease , Seoul, Republic of Korea ( 0412-CR02-0704-0001 ), and a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( A062260 ), sponsored by the Ministry of Health, Welfare & Family, Republic of Korea. The authors also received unrestricted grants from Abbott Vascular Korea and Boston Scientific Korea . The funding source of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the manuscript. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. ",

year = "2011",

month = oct,

day = "25",

doi = "10.1016/j.jacc.2011.07.031",

language = "English",

volume = "58",

pages = "1844--1854",

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

issn = "0735-1097",

publisher = "Elsevier USA",

number = "18",

}

Park, KW, Chae, IH, Lim, DS, Han, KR, Yang, HM, Lee, HY, Kang, HJ, Koo, BK, Ahn, T, Yoon, JH, Jeong, MH, Hong, TJ, Chung, WY, Jo, SH, Choi, YJ, Hur, SH, Kwon, HM, Jeon, DW, Kim, BO, Park, SH, Lee, NH, Jeon, HK, Gwon, HC, Jang, YS & Kim, HS 2011, 'Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial', Journal of the American College of Cardiology, vol. 58, no. 18, pp. 1844-1854. https://doi.org/10.1016/j.jacc.2011.07.031

Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial. / Park, Kyung Woo; Chae, In Ho; Lim, Do Sun et al.
In: Journal of the American College of Cardiology, Vol. 58, No. 18, 25.10.2011, p. 1844-1854.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention

T2 - The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial

AU - Park, Kyung Woo

AU - Chae, In Ho

AU - Lim, Do Sun

AU - Han, Kyoo Rok

AU - Yang, Han Mo

AU - Lee, Hae Young

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Ahn, Taehoon

AU - Yoon, Jung Han

AU - Jeong, Myung Ho

AU - Hong, Taek Jong

AU - Chung, Woo Young

AU - Jo, Sang Ho

AU - Choi, Young Jin

AU - Hur, Seung Ho

AU - Kwon, Hyuck Moon

AU - Jeon, Dong Woon

AU - Kim, Byung Ok

AU - Park, Si Hoon

AU - Lee, Nam Ho

AU - Jeon, Hui Kyung

AU - Gwon, Hyeon Cheol

AU - Jang, Yang Soo

AU - Kim, Hyo Soo

N1 - Funding Information: This study was supported by a grant from the Clinical Research Center for Ischemic Heart Disease , Seoul, Republic of Korea ( 0412-CR02-0704-0001 ), and a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( A062260 ), sponsored by the Ministry of Health, Welfare & Family, Republic of Korea. The authors also received unrestricted grants from Abbott Vascular Korea and Boston Scientific Korea . The funding source of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the manuscript. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

PY - 2011/10/25

Y1 - 2011/10/25

N2 - Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)

AB - Objectives: The goal of this study was to compare the angiographic outcomes of everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in a head-to-head manner. Background: EES have been shown to be superior to paclitaxel-eluting stents in inhibiting late loss (LL) and clinical outcome. Whether EES may provide similar angiographic and clinical outcomes compared with SES is undetermined. Methods: This was a prospective, randomized, open-label, multicenter trial to demonstrate the noninferiority of EES compared with SES in preventing LL at 9 months. A total of 1,443 patients undergoing percutaneous coronary intervention were randomized 3:1 to receive EES or SES. Routine follow-up angiography was recommended at 9 months. The primary endpoint was in-segment LL at 9 months, and major secondary endpoints included in-stent LL at 9 months, target lesion failure, cardiac death, nonfatal myocardial infarction, target lesion revascularization, and stent thrombosis at 12 months. Data were managed by an independent management center, and clinical events were adjudicated by an independent adjudication committee. Results: Clinical follow-up was available in 1,428 patients and angiographic follow-up in 924 patients (1,215 lesions). The primary endpoint of the study (in-segment LL at 9 months) was 0.11 ± 0.38 mm and 0.06 ± 0.36 mm for EES and SES, respectively (p for noninferiority = 0.0382). The in-stent LL was also noninferior (EES 0.19 ± 0.35 mm; SES 0.15 ± 0.34 mm; p for noninferiority = 0.0121). The incidence of clinical endpoints was not statistically different between the 2 groups, including target lesion failure (3.75% vs. 3.05%; p = 0.53) and stent thrombosis (0.37% vs. 0.83%; p = 0.38). Conclusions: EES were noninferior to SES in inhibition of LL after stenting, which was corroborated by similar rates of clinical outcomes. (Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting [EXCELLENT]; NCT00698607)

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Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY et al. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial. Journal of the American College of Cardiology. 2011 Oct 25;58(18):1844-1854. doi: 10.1016/j.jacc.2011.07.031

Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The excellent (efficacy of Xience/Promus versus cypher to reduce late loss after stenting) randomized trial

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

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