Results from a randomised study, presented at TCT 2013 this week, suggest Biosensors’ BioFreedom™ polymer free, drug coated stent, demonstrates similar four year outcomes as Boston Scientifics’ drug eluter, Taxus™ Liberté™. The conclusion is that BioFreedom seemingly represents a good option for patients not able to tolerate long term DAPT.
BioFreedom represents the latest development in Biosensors’ stent technology, featuring a micro-structured abluminal surface which permits the controlled release of Biolimus A9™ (BA9™) without the use of a polymer. BA9 is a highly lipophilic antirestenotic drug developed by Biosensors specifically for use with stents.
The sales pitch is that in certain patients prolonged dual anti-platelet therapy (DAPT) is not well tolerated. In these patients Bare Metal Stents (BMS) may be preferred. BioFreedom bridges the gap between the BMS and the Drug Eluting Stents with their sustained and prolonged release of anti-platelet drugs. As such the theory goes that as a Drug-Coated Stent (DCS), BioFreedom combines the advantages of both DES and BMS. It delivers an effective anti-restenotic therapy with Biolimus A9™, and may shorten the required DAPT regime.
This First in Man (‘FIM’) 182 patient study, is aiming to demonstrate equivalence in performance to a benchmark drug eluting stent, in this case Boston Scientific’s Taxus Liberté.
The results at four years, yielded no significant difference in MACE rates(a composite of all death, MI, emergent cardiac artery bypass graft (CABG) and target lesion revascularization (TLR)) (13.6% vs. 13.3%: p= non-significant (>0.05)).
While not statistically significant, Target Lesion Revascularisation was performed nearly half as often on patients treated with BioFreedom as on those treated with Taxus Liberté (5.2% vs. 10.2% p= non-significant (>0.05)).
BioFreedom demonstrated sustained safety up to four years, including absence of definite and/or probable stent thrombosis.
Results were presented by Dr. Ricardo Costa, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) meeting, sponsored by the Cardiovascular Research Foundation.
BioFreedom is in the process of being launched in selected international markets, with a full commercial launch anticipated during 2014. The device remains unapproved for sale in the United States.
Source: Biosensors International Group