Randomized Comparison of Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents in All-Comer Patients

Young Jin Youn, Jun Won Lee, Sung Gyun Ahn, Seung Hwan Lee, Junghan Yoon, Keum Soo Park, Jin Bae Lee, Sang Yong Yoo, Do Sun Lim, Jang Hyun Cho, Cheol Ung Choi, Myung Ho Jeong, Kyoo Rok Han, Kwang Soo Cha, Sung Yun Lee, Hyun Hee Choi, Jae Woong Choi, Min Su Hyon, Moo Hyun Kim

Research output: Contribution to journalArticle

Abstract

BACKGROUND: There is limited data comparing the Xience everolimus-eluting stent (EES) and the Resolute zotarolimus-eluting stent (ZES) with the BioMatrix biolimus-eluting stent (BES). METHODS: This open-label, randomized, noninferiority trial enrolled all-comer patients to be randomly treated with either BES, EES, or ZES in a 1:1:1 ratio in 15 centers across South Korea. The primary end point was a device-oriented composite outcome consisting of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization at 24 months. The BES was compared with the EES and the ZES by intention-to-treat analyses with a noninferiority margin of 3.8%, respectively. RESULTS: Because of slow recruitment and low event rates, this trial was prematurely terminated after enrollment of 1935 (75%) of the intended 2580 patients. Of the 1911 patients randomized to either EES (n=638), BES (n=634), or ZES (n =639), the rate of device-oriented composite outcome was 3.6%, 2.2%, and 3.9%, respectively, at 24 months (BES versus EES: absolute risk difference -1.4% [upper limit of 1-sided 95% CI: -3.2%]; Pfor noninferiority <0.001; BES versus ZES: absolute risk difference -1.7% [upper limit of 1-sided 95% CI: -3.6%]; Pfor noninferiority <0.001). CONCLUSIONS: The BES was noninferior to either the EES or the ZES in all-comer patients for device-oriented composite outcome at the 24-month follow-up. However, caution is advised regarding interpretation of these results due to the premature termination of this study. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01397175.

Original languageEnglish
Pages (from-to)e008525
JournalCirculation. Cardiovascular interventions
Volume13
Issue number3
DOIs
Publication statusPublished - 2020 Mar 1

Keywords

  • coronary artery disease
  • drug-eluting stent
  • myocardial infarction
  • percutaneous coronary intervention
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Youn, Y. J., Lee, J. W., Ahn, S. G., Lee, S. H., Yoon, J., Park, K. S., Lee, J. B., Yoo, S. Y., Lim, D. S., Cho, J. H., Choi, C. U., Jeong, M. H., Han, K. R., Cha, K. S., Lee, S. Y., Choi, H. H., Choi, J. W., Hyon, M. S., & Kim, M. H. (2020). Randomized Comparison of Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents in All-Comer Patients. Circulation. Cardiovascular interventions, 13(3), e008525. https://doi.org/10.1161/CIRCINTERVENTIONS.119.008525