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Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk

Authors:
Stephan Windecker, Azeem Latib, Elvin Kedhi, Ajay J. Kirtane, David E. Kandzari, Roxana Mehran, Matthew J. Price, Alexandre Abizaid, Daniel I. Simon, Stephen G. Worthley et al for the ONYX ONE Investigators

Abstract

This multicenter, randomized, single-blind trial compared the safety and effectiveness of polymer-based zotarolimus-eluting stents versus polymer-free umirolimus-coated stents in 1,996 patients at high bleeding risk undergoing percutaneous coronary intervention (PCI). All participants received 1 month of dual antiplatelet therapy. The primary outcome a composite of cardiac death, myocardial infarction, or stent thrombosis occurred in 17.1% (zotarolimus group) and 16.9% (polymer-free group), meeting the criterion for noninferiority (P=0.01). The key secondary outcome of target-lesion failure was also noninferior between groups (17.6% vs. 17.4%, P=0.007). Bleeding events and stent thrombosis rates were comparable, supporting the use of either stent type in this population.

Keywords: high bleeding risk PCI drug-eluting stents zotarolimus umirolimus dual antiplatelet therapy randomized trial stent thrombosis target-lesion failure ONYX ONE
DOI: https://doi.ms/10.00420/ms/8622/I2BCH/YCU | Volume: 382 | Issue: 13 | Views: 0
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