Results of Zotarolimus-Eluting Stents vs Biolimus-Eluting Polymer-Free Stents After 2 Years. Are They Safe in Patients at High Risk for Bleeding?

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.

Resultados a 2 años de los stents liberadores de Zotarolimus vs stents libres de polímero liberadores de Biolimus. ¿Son seguros en pacientes con alto riesgo de sangrado?

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).

Read also: PCI on Native Arteries or Saphenous Vein Grafts: Which Has Better Prognosis?

There were no differences in the PEP and the SEP between groups at 2 years of follow-up.


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

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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