Background: Patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment-elevation myocardial infarction (STEMI) have a high thrombotic burden and often have a high bleeding risk (HBR). Asian patients have different patterns of thrombotic and bleeding risk from other populations which may be particularly relevant in the setting of PPCI for STEMI.
Objectives: To assess the safety and efficacy of the polymer free biolimus coated coronary stent (PF-BCS, BioFreedomTM, Biosensors International) in Asian STEMI patients.
Methods: Patients with acute STEMI who received at least one PF-BCS were invited to participate after their index procedure. Follow-up was performed at 1, 4, and 12 months. The primary endpoint was the rate of target lesion failure (TLF) at 1 year. A performance goal was derived from the biolimus eluting stent arm of the COMFORTABLE AMI study which was the only prior dedicated study of biolimus eluting stents in patients with STEMI.
Results: A total of 914 patients with STEMI were enrolled. Mean patient age was 60 ± 13 years, diabetes was present in 23.2% and 43% were active smokers. According to the ARC definition, 12.4% of the patients were HBR. TLF rate was 2.54% [95% CI: 1.52-3.56], p-value for non-inferiority <0.0001, p-value for superiority = 0.0004). The rate of definite/probable stent thrombosis was 0.44% [95% CI: 0.16-1.16]. There was a trend toward more BARC 3 to 5 bleeding in ARC-HBR patients (3.69% vs 1.46%, HR = 2.74, [95% CI: 0.87-8.62], p = 0.07).
Conclusions: In Asian patients undergoing PPCI for STEMI and treated with variable durations of DAPT, the use of a PF-BCS was associated with low rates of TLF and stent thrombosis (NCT03609346).
Keywords: STEMI; biolimus coated stent; high bleeding risk patients; primary percutaneous coronary intervention.
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