In:
Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 13, No. 3 ( 2020-03)
Abstract:
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%]; P for noninferiority 〈 0.001; BES versus ZES: absolute risk difference −1.7% [upper limit of 1-sided 95% CI: −3.6%]; P for 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.
Type of Medium:
Online Resource
ISSN:
1941-7640
,
1941-7632
DOI:
10.1161/CIRCINTERVENTIONS.119.008525
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2020
detail.hit.zdb_id:
2450801-9
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