Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice

Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries

Kyung Woo Park, Joo Myung Lee, Si Hyuck Kang, Hyo Suk Ahn, Han Mo Yang, Hae Young Lee, Hyun Jae Kang, Bon Kwon Koo, Janghyun Cho, Hyeon Cheol Gwon, Sung Yoon Lee, In Ho Chae, Tae Jin Youn, Jei Keon Chae, Kyoo Rok Han, Cheol Woong Yu, Hyo Soo Kim

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Objectives: This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) (Medtronic Cardiovascular, Santa Rosa, California) in "all-comer" cohorts. Background: Only 2 randomized controlled trials have compared these stents. Methods: The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with the EES and 1,998 patients treated with the ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure [TLF]) and patient-related composite outcomes were compared in crude and propensity score-matched analyses. Results: Of 5,054 patients, 3,830 (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (82 [2.7%] vs. 58 [2.9%], p = 0.662) and the patient-related outcome (225 [7.4%] vs. 153 [7.7%], p = 0.702) did not differ between EES and ZES-R, respectively, at 1 year, which was corroborated by similar results from the propensity score-matched cohort. The rate of definite or probable stent thrombosis (18 [0.6%] vs. 7 [0.4%], p = 0.306) also was similar. In multivariate analysis, off-label indication was the strongest predictor of TLF (adjusted hazard ratio: 2.882; 95% confidence interval: 1.226 to 6.779; p = 0.015). Conclusions: In this robust real-world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 1-year follow-up. Overall incidences of TLF and definite stent thrombosis were low, even in the patients with off-label indication, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents.

Original languageEnglish
Pages (from-to)537-544
Number of pages8
JournalJournal of the American College of Cardiology
Volume61
Issue number5
DOIs
Publication statusPublished - 2013 Feb 5
Externally publishedYes

Fingerprint

Korea
Stents
Registries
Safety
Propensity Score
Everolimus
zotarolimus
Thrombosis
Drug-Eluting Stents
Blood Vessels
Multivariate Analysis
Randomized Controlled Trials
Confidence Intervals

Keywords

  • clinical outcome
  • everolimus-eluting stent
  • patient-oriented composite outcome
  • Resolute zotarolimus-eluting stent
  • stent thrombosis
  • target lesion failure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice : Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries. / Park, Kyung Woo; Lee, Joo Myung; Kang, Si Hyuck; Ahn, Hyo Suk; Yang, Han Mo; Lee, Hae Young; Kang, Hyun Jae; Koo, Bon Kwon; Cho, Janghyun; Gwon, Hyeon Cheol; Lee, Sung Yoon; Chae, In Ho; Youn, Tae Jin; Chae, Jei Keon; Han, Kyoo Rok; Yu, Cheol Woong; Kim, Hyo Soo.

In: Journal of the American College of Cardiology, Vol. 61, No. 5, 05.02.2013, p. 537-544.

Research output: Contribution to journalArticle

Park, Kyung Woo ; Lee, Joo Myung ; Kang, Si Hyuck ; Ahn, Hyo Suk ; Yang, Han Mo ; Lee, Hae Young ; Kang, Hyun Jae ; Koo, Bon Kwon ; Cho, Janghyun ; Gwon, Hyeon Cheol ; Lee, Sung Yoon ; Chae, In Ho ; Youn, Tae Jin ; Chae, Jei Keon ; Han, Kyoo Rok ; Yu, Cheol Woong ; Kim, Hyo Soo. / Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice : Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries. In: Journal of the American College of Cardiology. 2013 ; Vol. 61, No. 5. pp. 537-544.
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title = "Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice: Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries",
abstract = "Objectives: This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) (Medtronic Cardiovascular, Santa Rosa, California) in {"}all-comer{"} cohorts. Background: Only 2 randomized controlled trials have compared these stents. Methods: The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with the EES and 1,998 patients treated with the ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure [TLF]) and patient-related composite outcomes were compared in crude and propensity score-matched analyses. Results: Of 5,054 patients, 3,830 (75.8{\%}) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (82 [2.7{\%}] vs. 58 [2.9{\%}], p = 0.662) and the patient-related outcome (225 [7.4{\%}] vs. 153 [7.7{\%}], p = 0.702) did not differ between EES and ZES-R, respectively, at 1 year, which was corroborated by similar results from the propensity score-matched cohort. The rate of definite or probable stent thrombosis (18 [0.6{\%}] vs. 7 [0.4{\%}], p = 0.306) also was similar. In multivariate analysis, off-label indication was the strongest predictor of TLF (adjusted hazard ratio: 2.882; 95{\%} confidence interval: 1.226 to 6.779; p = 0.015). Conclusions: In this robust real-world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 1-year follow-up. Overall incidences of TLF and definite stent thrombosis were low, even in the patients with off-label indication, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents.",
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T1 - Safety and efficacy of second-generation everolimus-eluting Xience v Stents versus zotarolimus-eluting resolute stents in real-world practice

T2 - Patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries

AU - Park, Kyung Woo

AU - Lee, Joo Myung

AU - Kang, Si Hyuck

AU - Ahn, Hyo Suk

AU - Yang, Han Mo

AU - Lee, Hae Young

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Cho, Janghyun

AU - Gwon, Hyeon Cheol

AU - Lee, Sung Yoon

AU - Chae, In Ho

AU - Youn, Tae Jin

AU - Chae, Jei Keon

AU - Han, Kyoo Rok

AU - Yu, Cheol Woong

AU - Kim, Hyo Soo

PY - 2013/2/5

Y1 - 2013/2/5

N2 - Objectives: This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) (Medtronic Cardiovascular, Santa Rosa, California) in "all-comer" cohorts. Background: Only 2 randomized controlled trials have compared these stents. Methods: The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with the EES and 1,998 patients treated with the ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure [TLF]) and patient-related composite outcomes were compared in crude and propensity score-matched analyses. Results: Of 5,054 patients, 3,830 (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (82 [2.7%] vs. 58 [2.9%], p = 0.662) and the patient-related outcome (225 [7.4%] vs. 153 [7.7%], p = 0.702) did not differ between EES and ZES-R, respectively, at 1 year, which was corroborated by similar results from the propensity score-matched cohort. The rate of definite or probable stent thrombosis (18 [0.6%] vs. 7 [0.4%], p = 0.306) also was similar. In multivariate analysis, off-label indication was the strongest predictor of TLF (adjusted hazard ratio: 2.882; 95% confidence interval: 1.226 to 6.779; p = 0.015). Conclusions: In this robust real-world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 1-year follow-up. Overall incidences of TLF and definite stent thrombosis were low, even in the patients with off-label indication, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents.

AB - Objectives: This study sought to compare the safety and efficacy of the Xience V/Promus everolimus-eluting stent (EES) (Abbott Vascular, Temecula, California) with the Endeavor Resolute zotarolimus-eluting stent (ZES-R) (Medtronic Cardiovascular, Santa Rosa, California) in "all-comer" cohorts. Background: Only 2 randomized controlled trials have compared these stents. Methods: The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with the EES and 1,998 patients treated with the ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure [TLF]) and patient-related composite outcomes were compared in crude and propensity score-matched analyses. Results: Of 5,054 patients, 3,830 (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (82 [2.7%] vs. 58 [2.9%], p = 0.662) and the patient-related outcome (225 [7.4%] vs. 153 [7.7%], p = 0.702) did not differ between EES and ZES-R, respectively, at 1 year, which was corroborated by similar results from the propensity score-matched cohort. The rate of definite or probable stent thrombosis (18 [0.6%] vs. 7 [0.4%], p = 0.306) also was similar. In multivariate analysis, off-label indication was the strongest predictor of TLF (adjusted hazard ratio: 2.882; 95% confidence interval: 1.226 to 6.779; p = 0.015). Conclusions: In this robust real-world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 1-year follow-up. Overall incidences of TLF and definite stent thrombosis were low, even in the patients with off-label indication, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents.

KW - clinical outcome

KW - everolimus-eluting stent

KW - patient-oriented composite outcome

KW - Resolute zotarolimus-eluting stent

KW - stent thrombosis

KW - target lesion failure

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