Key result
At two years, the BioFreedom stent showed no significant difference in target lesion failure compared to the Orsiro stent (7.8% vs 6.3%; RR 1.23), but resulted in a higher rate of target lesion revascularisation.
Why the study?
At one-year follow-up in SORT OUT IX, the BioFreedom stent did not meet non-inferiority criteria for target lesion failure versus the Orsiro stent and had higher TLR, prompting evaluation of two-year outcomes in all-comer patients.
Does a polymer-free biolimus-coated stent reduce target lesion failure compared to an ultrathin-strut biodegradable polymer sirolimus-eluting stent in all-comer patients undergoing coronary stenting?
RCT (n=3,151)
Single-blind
Randomized
Yes
Does a polymer-free biolimus-coated stent reduce target lesion failure compared to an ultrathin-strut biodegradable polymer sirolimus-eluting stent in all-comer patients undergoing coronary stenting?
At two years, the polymer-free biolimus-coated stent showed no significant difference in target lesion failure compared to the ultrathin-strut biodegradable polymer sirolimus-eluting stent, though it had a higher rate of target lesion revascularization driven by first-year events.
Answers are grounded in this paper and cite their sources.
No TLF benefit with polymer-free biolimus stent at 2 years; extends evidence of comparable performance versus ultrathin biodegradable-polymer sirolimus stents in all-comers.
BACKGROUND: For patients with high bleeding risk, the BioFreedom stent is safer and more effective than a bare metal stent. However, at the one-year follow-up of the SORT OUT IX trial, the BioFreedom stent did not meet the criteria for non-inferiority for target lesion failure (TLF) when compared with the Orsiro stent and had a higher incidence of target lesion revascularisation (TLR). AIMS: The aim of the study was to compare the two-year outcomes following coronary implantation of the BioFreedom or the Orsiro stents in all-comer patients. METHODS: The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX trial is a prospective, multicentre, randomised clinical trial comparing the BioFreedom and the Orsiro stents. The primary endpoint, TLF, was a composite of cardiac death, myocardial infarction (MI; not related to other lesions) and TLR. RESULTS: A total of 1,572 patients were randomised to treatment with the BioFreedom stent and 1,579 patients with the Orsiro stent. At two-year follow-up, TLF was 7.8% in the BioFreedom and 6.3% in the Orsiro stent groups (rate ratio [RR] 1.23, 95% confidence interval [CI]: 0.94-1.61). Risks of cardiac death, MI and definite stent thrombosis did not differ significantly between the groups, whereas more patients in the BioFreedom group had TLR (5.1% vs 2.6%; RR 1.98, 95% CI: 1.26-2.89) attributable to a higher risk of TLR within the first year (3.5% vs 1.3%; RR 2.77, 95% CI: 1.66-4.62). CONCLUSIONS: At two years, there were no significant differences between the BioFreedom and Orsiro stents for TLF. TLR was significantly higher with the BioFreedom stent due to higher risk of TLR within the first year.
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A 2022 study conducted an RCT in Coronary artery disease (n=3,151). BioFreedom stent vs. Orsiro stent was evaluated on Target lesion failure (composite of cardiac death, myocardial infarction not related to other lesions, and target lesion revascularisation) (RR 1.23, 95% CI 0.94-1.61, p=0.12). At two years, the BioFreedom stent showed no significant difference in target lesion failure compared to the Orsiro stent (7.8% vs 6.3%; RR 1.23), but resulted in a higher rate of target lesion revascularisation.
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