Key result
Biolimus-eluting stents showed no significant difference compared to everolimus-eluting stents for the composite of death, MI, and target vessel revascularization at two years (10.5% vs 11.5%; HR 1.11; 95% CI 0.61-2.00; P=0.74).
Why the study?
Does biolimus-eluting stent with biodegradable polymer improve clinical outcomes compared to everolimus-eluting stent with durable polymer in patients undergoing PCI?
Cohort (n=814)
Does biolimus-eluting stent with biodegradable polymer improve clinical outcomes compared to everolimus-eluting stent with durable polymer in patients undergoing PCI?
Hazard Ratio: 1.11 (95% CI 0.61–2)
Absolute Event Rate: 10.5% vs 11.5%
p-value: p=0.74
There was no significant difference in safety or efficacy between biolimus-eluting stents with biodegradable polymer and everolimus-eluting stents with durable polymer at two years.
Comparable 2-year outcomes observed with both stents; leaves open whether biodegradable polymer confers benefit in PCI.
AIMS: Second-generation everolimus-eluting stents (EES) are safer and more efficient than first-generation paclitaxel-eluting stents (PES). Third-generation biolimus-eluting stents (BES) have been found to be non-inferior to PES. To date, there is no available comparative study between EES and BES. We aimed to investigate the safety and efficacy of BES with biodegradable polymer compared to EES with durable polymer at a follow-up of two years in an unselected population of consecutively enrolled patients. METHODS AND RESULTS: A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up. Median follow-up was 22 months. The primary outcome occurred in 11.5% of EES and 10.5% of BES patients (HR 1.11, 95% CI: 0.61-2.00, p=0.74). At two years, there was no significant difference with regard to death (HR 0.49, 95% CI: 0.18-1.34, p=0.17), cardiac death (HR 0.14, 95% CI: 0.02-1.14, p=0.66) or MI (HR 6.10, 95% CI: 0.73-50.9, p=0.10). Stent thrombosis (ST) incidence was evenly distributed between EES (n=2) and BES (n=2) (p-value=1.0). CONCLUSIONS: This first clinical study failed to demonstrate any significant difference regarding safety or efficacy between these two types and generations of drug-eluting stents (DES).
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Puricel et al. (2013) conducted a cohort in percutaneous coronary intervention (PCI) (n=814). Biolimus-eluting stents (BES) vs. Everolimus-eluting stents (EES) was evaluated on Composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) (HR 1.11, 95% CI 0.61-2.00, p=0.74). Biolimus-eluting stents showed no significant difference compared to everolimus-eluting stents for the composite of death, MI, and target vessel revascularization at two years (10.5% vs 11.5%; HR 1.11; 95% CI 0.61-2.00; P=0.74).
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