The proportion of patients treated with coronary angioplasty who are at a high risk for bleeding is increasing. In this population, extended dual antithrombotic therapy increases the risk of bleeding.
The 1-year randomized Onyx one study has demonstrated the non-inferiority of zotarolimus-eluting stents (ZES) vs. biolimus-coated polymer-free stent BioFreedom (DCS). Patients received dual-antiplatelet therapy (DAPT) until the first month after coronary angioplasty, and then continued with single-antiplatelet therapy (SAPT).
The aim of this study was to present the 2-year results.
The primary endpoint (PEP) was a composite of cardiovascular death, acute myocardial infarction, probable or definite stent thrombosis. The secondary endpoint (SEP) was treated lesion failure.
The study analyzed 1996 patients; 1003 were randomized to the ZES arm and 993, to the DCS arm. Mean patient age was 74 years old, and most subjects were male. Fifty-two percent of patients experienced acute coronary syndrome (most frequently non-ST-segment elevation myocardial infarction).
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There were no differences in the PEP and the SEP between groups at 2 years of follow-up.
Conclusion
Among patients at high risk for bleeding treated with one month of DAPT followed by SAPT, Resolute Onyx stents had similar safety and effectiveness outcomes compared with BioFreedom stents at the 2-year follow-up.
Dr. Andrés Rodríguez
Member of the Editorial Board of SOLACI.org.
Original Title: Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients Final 2-Year Results From Onyx ONE.
Reference: Stephan Windecker, MD et alJ Am Coll Cardiol Intv 2022;15:1153–1163.
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