BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis - BIONICS
Contribution To Literature:
The BIONICS trial showed that a ridaforolimus-eluting stent was noninferior to a zotarolimus-eluting stent.
The goal of the trial was to evaluate a ridaforolimus-eluting stent compared with a zotarolimus-eluting stent among patients undergoing percutaneous coronary intervention (PCI).
Patients undergoing PCI were randomized to a ridaforolimus-eluting stent (n = 958) versus a zotarolimus-eluting stent (n = 961). Dual antiplatelet therapy was mandated for 6 months.
- Total number of enrollees: 1,919
- Duration of follow-up: 12 months
- Mean patient age: 64 years
- Percentage female: 22%
- Percentage with diabetes: 33%
- Percentage with acute coronary syndrome: 40%
- Patients ≥18 years of age undergoing PCI
- Reference vessel diameter 2.5-4.25 mm
- Recent myocardial infarction (MI)
- Chronic total occlusion
- Bifurcation lesions
- Calcified lesions
- Bypass graft stenosis
- Bare-metal in-stent restenosis
- ST-segment elevation MI within 24 hours
- Left ventricular ejection fraction <30%
- Acute stent thrombosis
- Renal dysfunction (creatinine clearance <30 ml/min)
- Prior PCI within 12 months
The primary outcome, incidence of target lesion failure at 12 months, occurred in 5.4% of the ridaforolimus-eluting stent group versus 5.4% of the zotarolimus-eluting stent group (p for noninferiority = 0.001).
- Death: 1.2% vs. 1.0% (p = 0.82); respectively, for ridaforolimus vs. zotarolimus
- Definite/probable stent thrombosis: 0.4% vs. 0.6% (p = 0.53); respectively, for ridaforolimus vs. zotarolimus
Among patients undergoing PCI, the novel ridaforolimus-eluting stent was noninferior to the zotarolimus-eluting stent. The ridaforolimus-eluting stent was associated with a similar incidence of target vessel failure compared with the zotarolimus-eluting stent. Mortality and stent thrombosis were also similar between treatment arms. Further study of the ridaforolimus-eluting stent is warranted.
Kandzari DE, Smits PC, Love MP, et al. Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial. Circulation 2017;Aug 9:[Epub ahead of print].
Keywords: Acute Coronary Syndrome, Constriction, Pathologic, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Sirolimus, Stents, Thrombosis
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