Key result
Thin-strut Orsiro stent is non-inferior to thick-strut BioMatrix for 18-month target lesion failure.
Why the study?
The trial aimed to compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting stent (Orsiro) with a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix).
Does a thin-strut biodegradable polymer sirolimus-eluting stent prevent target lesion failure compared to a thick-strut biodegradable polymer biolimus-eluting stent in patients undergoing percutaneous coronary intervention?
RCT (n=2,341)
Open-label
Block randomisation by centre (1:1)
Yes
Does a thin-strut biodegradable polymer sirolimus-eluting stent prevent target lesion failure compared to a thick-strut biodegradable polymer biolimus-eluting stent in patients undergoing percutaneous coronary intervention?
Effect estimate: HR 0.70 (95% CI 0.42-1.18)
Absolute Event Rate: 2.1% vs 2.9%
p-value: p=<0.0001 for non-inferiority
In an all-comer population undergoing PCI with a high prevalence of ACS, the thin-strut Orsiro sirolimus-eluting stent was non-inferior to the thick-strut BioMatrix biolimus-eluting stent for target lesion failure at 18 months.
Supports thin- versus thick-strut stent choice in PCI; confirms non-inferiority for TLF in all-comers.
AIMS: The aim of this trial was to compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix). METHODS AND RESULTS: This randomised, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF). Between July 2014 and September 2017, we randomly assigned 2,341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175). We analysed 2,327 patients who completed 18-month follow-up. The mean patient age was 63.5 years, and 1,565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio [HR] 0.70, upper limit of one-sided 95% confidence interval: 1.18, p for non-inferiority <0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs 12 [1.0%], p=0.558), target lesion-related myocardial infarction (0 [0%] vs 3 [0.3%], p=0.250), target lesion revascularisation (18 [1.6%] vs 10 [0.9%], p=0.124), or stent thrombosis (0 [0%] vs 2 [0.2%], p=0.50). CONCLUSIONS: In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed good clinical outcomes.
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Yoon et al. (2021) conducted an RCT in Coronary artery disease (n=2,341). Orsiro stent vs. BioMatrix stent was evaluated on Target lesion failure (TLF) at 18 months (HR 0.70, 95% CI 0.42-1.18, p=<0.0001 for non-inferiority). The thin-strut Orsiro stent was non-inferior to the thick-strut BioMatrix stent for 18-month target lesion failure in patients with coronary artery disease (2.1% vs 2.9%, HR 0.70, p<0.0001 for non-inferiority).
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