Why the study?
Does the polymer-free biolimus A9-coated BioFreedom stent reduce major adverse cardiovascular events at 12 months in an all-comers population treated with percutaneous coronary intervention?
Does the polymer-free biolimus A9-coated BioFreedom stent reduce major adverse cardiovascular events at 12 months in an all-comers population treated with percutaneous coronary intervention?
The polymer-free biolimus A9-coated BioFreedom stent failed to demonstrate noninferiority to the biodegradable polymer sirolimus-eluting Orsiro stent for 12-month major adverse cardiovascular events in an all-comers PCI population.
BioFreedom not noninferior to Orsiro for 12-month MACE post-PCI; challenges polymer-free stent use in all-comers populations.
The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
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Jensen et al. (2020) studied this question.
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