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
UR - http://www.scopus.com/inward/record.url?scp=84901248019&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2013.12.201
DO - 10.1016/j.jcin.2013.12.201
M3 - Article
C2 - 24852802
AN - SCOPUS:84901248019
SN - 1936-8798
VL - 7
SP - 471
EP - 481
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 5
ER -