Key result
BioFreedom stents show no benefit over Orsiro stents for 5-year TLF in ACS.
Why the study?
Does the polymer-free biolimus-coated stent reduce target lesion failure compared to the biodegradable-polymer sirolimus-eluting stent in patients with acute coronary syndromes?
RCT (n=1,672)
Does the polymer-free biolimus-coated stent reduce target lesion failure compared to the biodegradable-polymer sirolimus-eluting stent in patients with acute coronary syndromes?
Relative Risk: 1.12 (95% CI 0.84–1.49)
Absolute Event Rate: 12.5% vs 10.8%
At 5-year follow-up, the polymer-free biolimus-coated stent and biodegradable-polymer sirolimus-eluting stent showed similar rates of target lesion failure in ACS patients, despite an early increased risk of TLR with the biolimus stent in STEMI patients.
Supports either stent for ACS PCI; extends prior data by resolving early TLR signal in STEMI.
BACKGROUND: The polymer-free biolimus A9-coated BioFreedom stent (BF-BCS) releases a lipophilic drug that may provide a potent anti-inflammatory effect in patients with acute coronary syndromes (ACS). Five-year efficacy and safety of BF-BCS were compared to the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent (O-SES) in ACS patients. METHODS: From SORT OUT IX, 1672 ACS patients were analyzed (821 treated with BF-BCS and 851 with O-SES); 764 (46%) presented with ST-segment-elevation myocardial infarction (STEMI) and 907 (54%) with non-STEMI. Endpoints were target lesion failure (TLF) (a composite of cardiac death, target lesion myocardial infarction [MI], target lesion revascularization [TLR]) and definite stent thrombosis (ST) at 5-years. RESULTS: At 5-years, TLF in ACS patients did not differ significantly between BF-BCS and O-SES (12.5% vs. 10.8%; rate ratio (RR) 1.12; 95% confidence interval (CI): 0.84-1.49). Cardiac death, target lesion MI, and definite ST rates were similar. TLR was higher with BF-BCS compared to O-SES within the first year (2.9% vs. 1.2%, RR 2.37; 95% CI: 1.13-4.99), but this difference was not maintained at 5-year follow-up (6.2% vs. 4.3%; RR 1.42; 95% CI: 0.92-2.18). The increased risk of TLR within the first year was driven by increased risk of TLR in STEMI patients treated with BF-BCS compared to O-SES (2.5% vs. 0.3%, RR 9.96; 95% CI: 1.26-79.0), while there were no differences in TLR rates in NSTEMI patients. CONCLUSION: At 5-year follow-up, TLF did not differ significantly in BF-BCS or O-SES treated ACS patients. The increased risk of early TLR in STEMI patients treated with BF-BCS was not maintained at 5-year follow-up.
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Noori et al. (2026) conducted an RCT in Acute coronary syndromes (ACS) (n=1,672). Polymer-free biolimus A9-coated BioFreedom stent (BF-BCS) vs. Biodegradable polymer sirolimus-eluting Orsiro stent (O-SES) was evaluated on Target lesion failure (TLF) (a composite of cardiac death, target lesion myocardial infarction [MI], target lesion revascularization [TLR]) at 5-years (RR 1.12, 95% CI 0.84-1.49). The polymer-free BioFreedom stent showed no significant difference in 5-year target lesion failure compared to the Orsiro stent in ACS patients (12.5% vs 10.8%; RR 1.12; 95% CI 0.84-1.49).
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