Early Healing Profile Established for BioFreedom
Paris, France, The first
study to demonstrate rapid early healing for BioFreedom™, a novel polymer and
carrier-free drug-coated stent (DCS), was presented at EuroPCR 2015 by
Professor Stephen Lee, Division of Cardiology, Queen Mary Hospital, University
of Hong Kong. Results in the first twelve months demonstrate rapid strut
coverage, suggesting an early healing profile for patients using BioFreedom.
Lee’s Optical Coherence
Tomography (OCT) analysis demonstrated that 86% of struts were covered at one
month, and 97% at five months. The BioFreedom stent also showed effective
neointimal suppression at nine months and favourable clinical outcomes at
twelve months.
The EGO BioFreedom study used OCT to assess the degree of strut coverage in 100
patients treated with BioFreedom stents. All patients received a baseline OCT
assessment during PCI, and were then randomly divided into five groups of 20
for a second OCT assessment at one, two, three, four or five months. Every
patient received a third OCT assessment at nine months, to determine total
tissue coverage and neointimal growth. Clinical follow-up and MACE to 12 months
were also documented.
An average 85.77% of struts were covered at one month, 97.14% at five months,
and 99.55% at nine months. Neointimal thickness remained low over the study
follow-up, reaching 0.10mm at nine months, thereby confirming the
antiproliferative effect of the drug. At twelve months, there was a TLR
rate of 4%. No other incidents of MACE were recorded, and no definite or
probable late stent thrombosis was observed.
“This study provides proof of concept for a polymer-free biolimus-coated
stent”, commented Prof. Lee. “BioFreedom demonstrated an early healing profile,
in the form of rapid early strut coverage, while retaining its efficacy in
terms of neointimal suppression at nine months and clinical outcomes at twelve
months. If supported by long-term clinical results, this concept could have a
major impact on the future development of new stent platforms.”
BioFreedom represents the latest development in Biosensors’ stent technology,
featuring an abluminal coating of Biolimus A9™ (BA9™) without the use of a
polymer or other carrier. BA9 is a highly lipophilic anti-restenotic drug
developed by Biosensors specifically for use with stents. In its First-in-Man
(“FIM”) study, treatment with BioFreedom demonstrated excellent twelve-month
late lumen loss and sustained safety up to five years, including absence of
definite and/or probable stent thrombosis.
Another important clinical trial where BioFreedom is being studied is LEADERS
FREE, the world’s first prospective, randomised double-blind clinical trial
employing only a one-month course of dual anti-platelet therapy (DAPT) after
implantation of an active stent. The trial is focused on patients at high risk
of bleeding, and has been designed to confirm that BioFreedom is as safe as a
bare-metal stent (BMS) in this patient group, while delivering the
anti-restenotic benefit of a drug-eluting stent (DES).
LEADERS FREE has enrolled 2466 patients identified as having a high risk of
bleeding from 68 sites across Europe, Asia, Australia and Canada. Primary
endpoint data is expected later this year, and follow up is planned out to two
years.
BioFreedom has received CE Mark approval and is currently available in select
markets. Biosensors has also received conditional IDE approval to conduct a
US-based clinical trial of BioFreedom, designed to collect additional safety
and effectiveness data.
Source: Biosensors
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