title: Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries).
abstract: Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p <0.001) and off-label indication (adjusted HR 1.782, 95% CI 1.169 to 2.718, p = 0.007) were the strongest predictors of target lesion failure at 3 years. In conclusion, both stents showed comparable safety and efficacy at 3-year follow-up in this robust real-world registry with unrestricted use of EES and ZES-R. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off-label indications, suggesting excellent long-term safety and sustained efficacy of both types of second-generation drug-eluting stents.
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Joo Myung
authors.initials: JM
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Kyung Woo
authors.initials: KW
authors.lastname: Park
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Jung-Kyu
authors.initials: JK
authors.lastname: Han
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Han-Mo
authors.initials: HM
authors.lastname: Yang
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Bon-Kwon
authors.initials: BK
authors.lastname: Koo
authors.affiliation: Chungbuk National University, Cheongju, Republic of Korea.
authors.forename: Jang-Whan
authors.initials: JW
authors.lastname: Bae
authors.affiliation: Inha University Hospital, Incheon, Republic of Korea.
authors.forename: Sung-Il
authors.initials: SI
authors.lastname: Woo
authors.affiliation: Sejong General Hospital, Sejong Heart Institute, Bucheon, Republic of Korea.
authors.forename: Jin Sik
authors.initials: JS
authors.lastname: Park
authors.affiliation: Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.
authors.forename: Dong-Kyu
authors.initials: DK
authors.lastname: Jin
authors.affiliation: National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.
authors.forename: Dong Woon
authors.initials: DW
authors.lastname: Jeon
authors.affiliation: Wonkwang University School of Medicine, Iksan, Republic of Korea.
authors.forename: Seok Kyu
authors.initials: SK
authors.lastname: Oh
authors.affiliation: Yeungnam University Medical Center, Daegu, Republic of Korea.
authors.forename: Jong-Seon
authors.initials: JS
authors.lastname: Park
authors.affiliation: Inje University, Haeundae Paik Hospital, Busan, Republic of Korea.
authors.forename: Doo-Il
authors.initials: DI
authors.lastname: Kim
authors.affiliation: Soonchunhyang University Hospital, Seoul, Republic of Korea.
authors.forename: Min Su
authors.initials: MS
authors.lastname: Hyon
authors.affiliation: Uijeongbu St Mary's Hospital, Uijeongbu, Republic of Korea.
authors.forename: Hui-Kyung
authors.initials: HK
authors.lastname: Jeon
authors.affiliation: Korea University Anam Hospital, Seoul, Republic of Korea.
authors.forename: Do-Sun
authors.initials: DS
authors.lastname: Lim
authors.affiliation: Kyunghee University College of Medicine, Seoul, Republic of Korea.
authors.forename: Myeong-Gon
authors.initials: MG
authors.lastname: Kim
authors.affiliation: Korea University Guro, Hospital, Seoul, Republic of Korea.
authors.forename: Seung-Woon
authors.initials: SW
authors.lastname: Rha
authors.affiliation: Daejeon St. Mary's Hospital, Daejeon, Republic of Korea.
authors.forename: Sung-Ho
authors.initials: SH
authors.lastname: Her
authors.affiliation: Gyeongsang National University Hospital, Jinju, Republic of Korea.
authors.forename: Jin-Yong
authors.initials: JY
authors.lastname: Hwang
authors.affiliation: Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Sanghyun
authors.initials: S
authors.lastname: Kim
authors.affiliation: Sejong General Hospital, Sejong Heart Institute, Bucheon, Republic of Korea.
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Choi
authors.affiliation: Kangbuk Samsung Hospital, Seoul, Republic of Korea.
authors.forename: Jin Ho
authors.initials: JH
authors.lastname: Kang
authors.affiliation: St. Vincent's Hospital, Suwon, Republic of Korea.
authors.forename: Keon-Woong
authors.initials: KW
authors.lastname: Moon
authors.affiliation: Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: hyosoo@snu.ac.kr.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000970:Antineoplastic Agents; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D056910:Republic of Korea / Q000453:epidemiology; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus