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

Kyung Woo Park, Joo Myung Lee, Si Hyuk Kang, Hyo Suk Ahn, Hyun Jae Kang, Bonkwon 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

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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 languageEnglish
Pages (from-to)471-481
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume7
Issue number5
DOIs
StatePublished - 1 Jan 2014

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Stents
Diabetes Mellitus
Drug-Eluting Stents
Percutaneous Coronary Intervention
Registries
Everolimus
zotarolimus
Safety
Propensity Score
Incidence
Korea
Chronic Kidney Failure
Multivariate Analysis

Keywords

  • diabetes mellitus
  • drug-eluting stent
  • everolimus
  • percutaneous coronary intervention
  • zotarolimus

Cite this

Park, Kyung Woo ; Lee, Joo Myung ; Kang, Si Hyuk ; Ahn, Hyo Suk ; Kang, Hyun Jae ; Koo, Bonkwon ; Rhew, Jay Young ; Hwang, Sun Ho ; Lee, Sung Yoon ; Kang, Tae Soo ; Kwak, Choong Hwan ; Hong, Bum Kee ; Yu, Cheol Woong ; Seong, In Whan ; Ahn, Taehoon ; Lee, Han Cheol ; Lim, Sang Wook ; Kim, Hyo-Soo. / Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus. In: JACC: Cardiovascular Interventions. 2014 ; Vol. 7, No. 5. pp. 471-481.
@article{8c29110f54a74573946189c8f3b46d81,
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 Hyuk} and Ahn, {Hyo Suk} and Kang, {Hyun Jae} and Bonkwon Koo 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 Hyo-Soo Kim",
year = "2014",
month = "1",
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doi = "10.1016/j.jcin.2013.12.201",
language = "English",
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journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
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Park, KW, Lee, JM, Kang, SH, Ahn, HS, Kang, HJ, Koo, B, Rhew, JY, Hwang, SH, Lee, SY, Kang, TS, Kwak, CH, Hong, BK, Yu, CW, Seong, IW, Ahn, T, Lee, HC, Lim, SW & Kim, H-S 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

Everolimus-eluting xience V/promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus. / Park, Kyung Woo; Lee, Joo Myung; Kang, Si Hyuk; Ahn, Hyo Suk; Kang, Hyun Jae; Koo, Bonkwon; Rhew, Jay Young; Hwang, Sun Ho; Lee, Sung Yoon; Kang, Tae Soo; Kwak, Choong Hwan; Hong, Bum Kee; Yu, Cheol Woong; Seong, In Whan; Ahn, Taehoon; Lee, Han Cheol; Lim, Sang Wook; Kim, Hyo-Soo.

In: JACC: Cardiovascular Interventions, Vol. 7, No. 5, 01.01.2014, p. 471-481.

Research output: Contribution to journalArticle

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 Hyuk

AU - Ahn, Hyo Suk

AU - Kang, Hyun Jae

AU - Koo, Bonkwon

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

PY - 2014/1/1

Y1 - 2014/1/1

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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U2 - 10.1016/j.jcin.2013.12.201

DO - 10.1016/j.jcin.2013.12.201

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JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

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