Comparative Clinical Outcomes of Everolimus versus Biolimus-Eluting Stents: A Meta-Analysis of 27,071 Patients from Randomized Trials

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Abstract

Background

The comparative clinical outcomes of everolimus-eluting stents (EES) versus biolimus-eluting stents (BES) remains uncertain despite widespread use. This study conducted a systematic review and meta-analysis of randomized controlled trials comparing contemporary drug-eluting stent platforms.

Methods

We searched MEDLINE, Embase, CENTRAL, and Scopus through May 2025 for randomized trials comparing EES with BES in patients undergoing percutaneous coronary intervention. The primary outcomes were major adverse cardiac events (MACE) and device-oriented composite endpoint (DOCE) at the longest follow-up. Secondary outcomes included all-cause mortality, target lesion revascularization (TLR), and stent thrombosis. Random-effects meta-analysis was performed using risk ratios (RR) and 95% confidence intervals (CI). Heterogeneity was assessed using I² statistics. The GRADE approach evaluated the certainty of evidence.

Results

Thirteen trials randomizing 27,071 patients (12,226 EES; 14,845 BES), with follow-up 9-120 months, were included. EES demonstrated a trend toward reduced MACE compared with BES (9.7% vs 10.3%; RR 0.93, 95% CI: 0.87-1.00; p=0.053; I²=0%) with an absolute risk reduction of 0.7% (number needed to treat=142). DOCE showed similar results (RR 0.94, 95% CI: 0.88-1.01; p=0.10; I²=0%). No significant differences were observed for all-cause mortality (RR 0.96, 95% CI: 0.88-1.05; p=0.37), TLR (RR 0.95, 95% CI: 0.86-1.05; p=0.36), or stent thrombosis (RR 0.93, 95% CI: 0.69-1.23; p=0.60), all with I²=0%. Subgroup analysis by follow-up duration showed consistent results (p-interaction=0.88). No publication bias was detected. GRADE assessment indicated moderate certainty evidence for most outcomes.

Conclusions

In this meta-analysis, EES showed a trend toward reduced MACE compared with BES, though not reaching statistical significance. The remarkable homogeneity and small absolute differences suggest both platforms provide excellent outcomes. Both stent platforms remain appropriate first-line options for percutaneous coronary intervention.

Registration

PROSPERO CRD42025108092

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