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