Key result
Thin-strut cobalt-chromium BioFreedom stent proves non-inferior to stainless steel for 9-month late lumen loss.
Why the study?
The study aimed to evaluate the efficacy of the new thin-strut cobalt-chromium BioFreedom Ultra drug-coated stent compared with the stainless steel BioFreedom stent in an all-comers PCI population.
Does a thin-strut cobalt-chromium biolimus-eluting stent prevent in-stent late lumen loss compared to a thick-strut stainless steel biolimus-eluting stent in patients undergoing PCI?
RCT (n=200)
Open-label
1:1
Yes
Does a thin-strut cobalt-chromium biolimus-eluting stent prevent in-stent late lumen loss compared to a thick-strut stainless steel biolimus-eluting stent in patients undergoing PCI?
Absolute Event Rate: 0.34% vs 0.29%
p-value: p=0.005 for non-inferiority
The thin-strut cobalt-chromium biolimus-eluting stent is non-inferior to the thick-strut stainless steel biolimus-eluting stent regarding in-stent late lumen loss at 9 months.
Thin-strut cobalt-chromium BioFreedom may be preferred for deliverability in PCI; extends the BioFreedom platform with modern metallic backbone.
BACKGROUND: The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiv-ing only one-month dual antiplatelet therapy. AIMS: The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI). METHODS: This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year. RESULTS: A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the groups (7.3% in BF-CoCr vs 9.3% in the BF-SS group; p=0.60). CONCLUSIONS: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.
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Sabaté et al. (2021) conducted an RCT in Symptomatic coronary artery disease (n=200). BioFreedom cobalt-chromium stent (BF-CoCr) vs. BioFreedom stainless steel stent (BF-SS) was evaluated on In-stent late lumen loss (LLL) at 9 months (95% CI -0.069 to 0.167, p=0.005 for non-inferiority). The thin-strut cobalt-chromium BioFreedom stent was non-inferior to the stainless steel BioFreedom stent for in-stent late lumen loss at 9 months (0.34 mm vs 0.29 mm, p=0.005 for non-inferiority).
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