Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus

Kyung Woo Park; Joo Myung Lee; Si Hyuck Kang; Hyo Suk Ahn; Hyun Jae Kang; Bon Kwon Koo; Jay Young Rhew; Sun Ho Hwang; Sung Yoon Lee; Tae Soo Kang; Choong Hwan Kwak; Bum Kee Hong; Cheol Woong Yu; In Whan Seong; Taehoon Ahn; Han Cheol Lee; Sang Wook Lim; Hyo Soo Kim

doi:10.1016/j.jcin.2013.12.201

Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus

Kyung Woo Park, Joo Myung Lee, Si Hyuck Kang, Hyo Suk Ahn, Hyun Jae Kang, Bon Kwon Koo, Jay Young Rhew, Sun Ho Hwang, Sung Yoon Lee, Tae Soo Kang, Choong Hwan Kwak, Bum Kee Hong, Cheol Woong Yu, In Whan Seong, Taehoon Ahn, Han Cheol Lee, Sang Wook Lim, Hyo Soo Kim

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

57 Citations (Scopus)

Abstract

Objectives This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. Background DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. Methods Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. Results Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). Conclusions After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

Original language	English
Pages (from-to)	471-481
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	7
Issue number	5
DOIs	https://doi.org/10.1016/j.jcin.2013.12.201
Publication status	Published - 2014 May
Externally published	Yes

Bibliographical note

Funding Information:
This study was supported by a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( #A062260 ), sponsored by the Ministry of Health and Welfare, Republic of Korea . The 2 registries were also funded from unrestricted grants from Abbott Vascular Republic of Korea and Medtronic Republic of Korea . The funding sources of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the paper. Dr. H.-S. Kim has received unrestricted grants and lecture honoraria from Abbott Vascular Korea and Medtronic Republic of Korea. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Park and J. M. Lee contributed equally to this study.

Keywords

diabetes mellitus
drug-eluting stent
everolimus
percutaneous coronary intervention
zotarolimus

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jcin.2013.12.201

Cite this

Park, K. W., Lee, J. M., Kang, S. H., Ahn, H. S., Kang, H. J., Koo, B. K., Rhew, J. Y., Hwang, S. H., Lee, S. Y., Kang, T. S., Kwak, C. H., Hong, B. K., Yu, C. W., Seong, I. W., Ahn, T., Lee, H. C., Lim, S. W., & Kim, H. S. (2014). Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus. JACC: Cardiovascular Interventions, 7(5), 471-481. https://doi.org/10.1016/j.jcin.2013.12.201

Park, KW, Lee, JM, Kang, SH, Ahn, HS, Kang, HJ, Koo, BK, Rhew, JY, Hwang, SH, Lee, SY, Kang, TS, Kwak, CH, Hong, BK, Yu, CW, Seong, IW, Ahn, T, Lee, HC, Lim, SW & Kim, HS 2014, 'Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus', JACC: Cardiovascular Interventions, vol. 7, no. 5, pp. 471-481. https://doi.org/10.1016/j.jcin.2013.12.201

@article{453e7839e0d340c0941ccecaf56292e3,

title = "Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus",

abstract = "Objectives This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an {"}all-comer{"} group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. Background DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. Methods Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. Results Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). Conclusions After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.",

keywords = "diabetes mellitus, drug-eluting stent, everolimus, percutaneous coronary intervention, zotarolimus",

author = "Park, {Kyung Woo} and Lee, {Joo Myung} and Kang, {Si Hyuck} and Ahn, {Hyo Suk} and Kang, {Hyun Jae} and Koo, {Bon Kwon} and Rhew, {Jay Young} and Hwang, {Sun Ho} and Lee, {Sung Yoon} and Kang, {Tae Soo} and Kwak, {Choong Hwan} and Hong, {Bum Kee} and Yu, {Cheol Woong} and Seong, {In Whan} and Taehoon Ahn and Lee, {Han Cheol} and Lim, {Sang Wook} and Kim, {Hyo Soo}",

note = "Funding Information: This study was supported by a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( #A062260 ), sponsored by the Ministry of Health and Welfare, Republic of Korea . The 2 registries were also funded from unrestricted grants from Abbott Vascular Republic of Korea and Medtronic Republic of Korea . The funding sources of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the paper. Dr. H.-S. Kim has received unrestricted grants and lecture honoraria from Abbott Vascular Korea and Medtronic Republic of Korea. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Park and J. M. Lee contributed equally to this study. ",

year = "2014",

month = may,

doi = "10.1016/j.jcin.2013.12.201",

language = "English",

volume = "7",

pages = "471--481",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "5",

}

TY - JOUR

T1 - Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus

AU - Park, Kyung Woo

AU - Lee, Joo Myung

AU - Kang, Si Hyuck

AU - Ahn, Hyo Suk

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Rhew, Jay Young

AU - Hwang, Sun Ho

AU - Lee, Sung Yoon

AU - Kang, Tae Soo

AU - Kwak, Choong Hwan

AU - Hong, Bum Kee

AU - Yu, Cheol Woong

AU - Seong, In Whan

AU - Ahn, Taehoon

AU - Lee, Han Cheol

AU - Lim, Sang Wook

AU - Kim, Hyo Soo

N1 - Funding Information: This study was supported by a grant from the Innovative Research Institute for Cell Therapy , Seoul National University Hospital ( #A062260 ), sponsored by the Ministry of Health and Welfare, Republic of Korea . The 2 registries were also funded from unrestricted grants from Abbott Vascular Republic of Korea and Medtronic Republic of Korea . The funding sources of the study had no role in study design, data collection, monitoring, analysis, interpretation, or writing of the paper. Dr. H.-S. Kim has received unrestricted grants and lecture honoraria from Abbott Vascular Korea and Medtronic Republic of Korea. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Park and J. M. Lee contributed equally to this study.

PY - 2014/5

Y1 - 2014/5

N2 - Objectives This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. Background DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. Methods Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. Results Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). Conclusions After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

AB - Objectives This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention. Background DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated. Methods Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization. Results Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001). Conclusions After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

KW - diabetes mellitus

KW - drug-eluting stent

KW - everolimus

KW - percutaneous coronary intervention

KW - zotarolimus

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ER -

Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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