- Question
- In patients at high bleeding risk undergoing PCI and treated with 1 month of dual antiplatelet therapy, is a polymer-based zotarolimus-eluting stent noninferior to a polymer-free drug-coated stent?
- Design
- International, randomized 1:1, single-blind trial enrolling 1996 patients; both groups received 1 month of dual antiplatelet therapy followed by single antiplatelet therapy. Both outcomes were powered for noninferiority.
- Population
- Patients at high bleeding risk undergoing percutaneous coronary intervention.
- Intervention
- Polymer-based zotarolimus-eluting stent (1003 patients), followed by 1 month of dual antiplatelet therapy and then a single antiplatelet agent.
- Control
- Polymer-free umirolimus-coated stent (993 patients), with the same antiplatelet regimen.
- Primary outcome
- Safety composite at 1 year: cardiac death, myocardial infarction, or stent thrombosis. The principal secondary outcome was target-lesion failure (cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization).
- Results
- The primary outcome occurred in 169 of 988 patients (17.1%) with the zotarolimus-eluting stent and in 164 of 969 (16.9%) with the polymer-free stent (risk difference 0.2 percentage points; upper boundary of one-sided 97.5% CI 3.5; noninferiority margin 4.1; P = 0.01 for noninferiority). Target-lesion failure occurred in 174 (17.6%) vs 169 (17.4%) (upper boundary 3.5; margin 4.4; P = 0.007 for noninferiority).
- Conclusion
- The polymer-based zotarolimus-eluting stent was noninferior to the polymer-free drug-coated stent for safety and effectiveness in patients at high bleeding risk given 1 month of dual antiplatelet therapy.
- Why it matters
- It showed that contemporary polymer-based drug-eluting stents are a valid option alongside polymer-free stents in patients at high bleeding risk who can receive short dual antiplatelet therapy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026