Randomized Comparison of Everolimus- and Zotarolimus-Eluting Coronary Stents With Biolimus-Eluting Stents in All-Comer Patients
| Autor: | Jae Woong Choi, Myung Ho Jeong, Sung Gyun Ahn, Kyoo Rok Han, Hyun-Hee Choi, Do Sun Lim, Min Su Hyon, Junghan Yoon, Sung Yun Lee, Kwang Soo Cha, Young Jin Youn, Sang Yong Yoo, Junwon Lee, Seung Hwan Lee, Keum Soo Park, Jang Hyun Cho, Jin Bae Lee, Moo Hyun Kim, Cheol Ung Choi |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Myocardial Ischemia Prosthesis Design Coronary artery disease Percutaneous Coronary Intervention Recurrence Risk Factors Internal medicine Republic of Korea medicine Humans Zotarolimus Myocardial infarction Everolimus Aged Sirolimus business.industry Percutaneous coronary intervention Stent Cardiovascular Agents Drug-Eluting Stents Middle Aged medicine.disease Thrombosis Treatment Outcome Drug-eluting stent Early Termination of Clinical Trials Cardiology Female Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Circulation. Cardiovascular interventions. 13(3) |
| ISSN: | 1941-7632 |
| Popis: | 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%]; P for noninferiority P for noninferiority 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. |
| Databáze: | OpenAIRE |
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