Everolimus-eluting Xience v/Promus versus zotarolimus-eluting resolute stents in patients with diabetes mellitus.
OBJECTIVE
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.
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Kyung Woo
KW
Park
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Joo Myung
JM
Lee
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Si-Hyuck
SH
Kang
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Hyo-Suk
HS
Ahn
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Hyun-Jae
HJ
Kang
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Bon-Kwon
BK
Koo
Department of Internal Medicine and Cardiovascular Center, Presbyterian Medical Center, Jeonju, Republic of Korea.
Jay Young
JY
Rhew
Department of Internal Medicine and Cardiovascular Center, Gwangju Veterans Hospital, Gwangju, Republic of Korea.
Sun Ho
SH
Hwang
Department of Internal Medicine and Cardiovascular Center, Inje University Ilsan Paik Hospital, Ilsan, Republic of Korea.
Sung Yoon
SY
Lee
Department of Internal Medicine and Cardiovascular Center, Dankook University Hospital, Cheonan, Republic of Korea.
Tae Soo
TS
Kang
Department of Internal Medicine and Cardiovascular Center, Gyeongsang National University Hospital, Jinju, Republic of Korea.
Choong Hwan
CH
Kwak
Department of Internal Medicine and Cardiovascular Center, Gangnam Severance Hospital, Seoul, Republic of Korea.
Bum-Kee
BK
Hong
Department of Internal Medicine and Cardiovascular Center, Sejong General Hospital, Sejong Heart Institute, Bucheon, Republic of Korea.
Cheol Woong
CW
Yu
Department of Internal Medicine and Cardiovascular Center, Chungnam University Hospital, Daejeon, Republic of Korea.
In-Whan
IW
Seong
Department of Internal Medicine and Cardiovascular Center, Gachon University Gil Hospital, Incheon, Republic of Korea.
Taehoon
T
Ahn
Department of Internal Medicine and Cardiovascular Center, Busan National University Hospital, Busan, Republic of Korea.
Han Cheol
HC
Lee
Department of Internal Medicine and Cardiovascular Center, CHA Bundang Medical Center and CHA University, Seongnam, Republic of Korea.
Sang Wook
SW
Lim
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.
Hyo-Soo
HS
Kim
D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000175:diagnosis / Q000401:mortality; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000175:diagnosis / Q000401:mortality; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000209:etiology* / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000150:complications; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D057216:Propensity Score; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D056910:Republic of Korea; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus
diabetes mellitus; drug-eluting stent; everolimus; percutaneous coronary intervention; zotarolimus