Polymer-based stents noninferior for patients with high bleeding risk

(HealthDay)—Polymer-based zotarolimus-eluting stents are noninferior to polymer-free drug-coated stents among patients at high bleeding risk undergoing percutaneous coronary intervention (PCI), according to a study published online Feb. 12 in the New England Journal of Medicine.

Stephan Windecker, M.D., from Bern University Hospital in Switzerland, and colleagues conducted a randomized, single-blind trial to compare polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. Patients were treated with one month of dual antiplatelet therapy after PCI followed by single antiplatelet therapy. A total of 1,996 patients were randomly assigned to receive either zotarolimus-eluting stents (1,003 patients) or polymer-free drug-coated stents (993 patients).

The researchers found that the primary outcome (safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis) at one year was observed in 17.1 and 16.9 percent of patients in the zotarolimus-eluting and polymer-free drug-coated stent groups, respectively. The principal secondary outcome of target-lesion failure (an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization) was observed in 17.6 and 17.4 percent of the zotarolimus-eluting and polymer-free drug-coated stent groups, respectively.

"Among patients at high bleeding risk, a strategy of PCI with a polymer-based zotarolimus-eluting stent followed by one month of dual antiplatelet therapy was noninferior to a polymer-free drug-coated stent," the authors write.

The study was funded by Medtronic.