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)

Joo Myung Lee, Kyung Woo Park, Jung Kyu Han, Han Mo Yang, Hyun Jae Kang, Bon Kwon Koo, Jang Whan Bae, Sung Il Woo, Jin Sik Park, Dong Kyu Jin, Dong Woon Jeon, Seok Kyu Oh, Jong Seon Park, Doo Il Kim, Min Su Hyon, Hui Kyung Jeon, Do-Sun Lim, Myeong Gon Kim, Seung-Woon Rha, Sung Ho Her & 7 others Jin Yong Hwang, Sanghyun Kim, Young Jin Choi, Jin Ho Kang, Keon Woong Moon, Yangsoo Jang, Hyo Soo Kim

Research output: Contribution to journalArticle

18 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1329-1338
Number of pages10
JournalAmerican Journal of Cardiology
Volume114
Issue number9
DOIs
Publication statusPublished - 2014 Jan 1

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Korea
Stents
Registries
Thrombosis
Confidence Intervals
Everolimus
zotarolimus
Propensity Score
Drug-Eluting Stents
Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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). / Lee, Joo Myung; Park, Kyung Woo; Han, Jung Kyu; Yang, Han Mo; Kang, Hyun Jae; Koo, Bon Kwon; Bae, Jang Whan; Woo, Sung Il; Park, Jin Sik; Jin, Dong Kyu; Jeon, Dong Woon; Oh, Seok Kyu; Park, Jong Seon; Kim, Doo Il; Hyon, Min Su; Jeon, Hui Kyung; Lim, Do-Sun; Kim, Myeong Gon; Rha, Seung-Woon; Her, Sung Ho; Hwang, Jin Yong; Kim, Sanghyun; Choi, Young Jin; Kang, Jin Ho; Moon, Keon Woong; Jang, Yangsoo; Kim, Hyo Soo.

In: American Journal of Cardiology, Vol. 114, No. 9, 01.01.2014, p. 1329-1338.

Research output: Contribution to journalArticle

Lee, JM, Park, KW, Han, JK, Yang, HM, Kang, HJ, Koo, BK, Bae, JW, Woo, SI, Park, JS, Jin, DK, Jeon, DW, Oh, SK, Park, JS, Kim, DI, Hyon, MS, Jeon, HK, Lim, D-S, Kim, MG, Rha, S-W, Her, SH, Hwang, JY, Kim, S, Choi, YJ, Kang, JH, Moon, KW, Jang, Y & Kim, HS 2014, '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)', American Journal of Cardiology, vol. 114, no. 9, pp. 1329-1338. https://doi.org/10.1016/j.amjcard.2014.07.065
Lee, Joo Myung ; Park, Kyung Woo ; Han, Jung Kyu ; Yang, Han Mo ; Kang, Hyun Jae ; Koo, Bon Kwon ; Bae, Jang Whan ; Woo, Sung Il ; Park, Jin Sik ; Jin, Dong Kyu ; Jeon, Dong Woon ; Oh, Seok Kyu ; Park, Jong Seon ; Kim, Doo Il ; Hyon, Min Su ; Jeon, Hui Kyung ; Lim, Do-Sun ; Kim, Myeong Gon ; Rha, Seung-Woon ; Her, Sung Ho ; Hwang, Jin Yong ; Kim, Sanghyun ; Choi, Young Jin ; Kang, Jin Ho ; Moon, Keon Woong ; Jang, Yangsoo ; Kim, Hyo Soo. / 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). In: American Journal of Cardiology. 2014 ; Vol. 114, No. 9. pp. 1329-1338.
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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.",
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T1 - 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)

AU - Lee, Joo Myung

AU - Park, Kyung Woo

AU - Han, Jung Kyu

AU - Yang, Han Mo

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Bae, Jang Whan

AU - Woo, Sung Il

AU - Park, Jin Sik

AU - Jin, Dong Kyu

AU - Jeon, Dong Woon

AU - Oh, Seok Kyu

AU - Park, Jong Seon

AU - Kim, Doo Il

AU - Hyon, Min Su

AU - Jeon, Hui Kyung

AU - Lim, Do-Sun

AU - Kim, Myeong Gon

AU - Rha, Seung-Woon

AU - Her, Sung Ho

AU - Hwang, Jin Yong

AU - Kim, Sanghyun

AU - Choi, Young Jin

AU - Kang, Jin Ho

AU - Moon, Keon Woong

AU - Jang, Yangsoo

AU - Kim, Hyo Soo

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

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