FRANCO Julia (2), SURUAGY-MOTTA Ricardo (1), FRANCO Julia (2), DEXHEIMER DA SILVA Leonardo (4), FARIAS Carlos (3), OLDRA Leonardo (5), BERTOLI Edmundo (6), NEVES Gabriel (10), CRAVEIRO MELO Pedro (7), PILEGGI Brunna (7), NUNES David (8), MARTINS FILHO Evandro (9)
(1) Cesmac Campus I, State of Alagoas, BRAZIL; (2) PUC, State of Paraná, BRAZIL; (3) UNINOVE - Campus Memorial, State of São Paulo, BRAZIL; (4) USP, State of São Paulo, BRAZIL; (5) Anhembi Morumbi University, State of São Paulo, BRAZIL; (6) Hospital Marieta Konder, State of Santa Catarina, BRAZIL; (7) InCor - Instituto do Coração do Hospital das Clínicas da FMUSP, State of São Paulo, BRAZIL; (8) Instituto Dante Pazzanese, State of São Paulo, BRAZIL; (9) Santa Casa de Misericórdia de Maceió, State of Alagoas, BRAZIL; (10) UEPA - Universidade do Estado do Pará - Campus I CCSE (Centro de Ciências Sociais e Educação), State of Pará, BRAZIL
AIMS
This meta-analysis sought to evaluate all-cause death and cardiovascular deaths in patients who underwent PCI with either SES or BES
METHODS AND RESULTS
Methods
We performed a systematic search of PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials through June 30, 2025. We included randomized controlled trials (RCTs) and controlled trials directly comparing BES with SES. The primary outcomes were all-cause mortality and cardiovascular (cardiac) death, analyzed within two predefined temporal windows: early-term ($\leq$ 1 year) and mid-term (> 1 to 5 years). Two reviewers independently screened studies, assessed quality, and extracted event counts. Statistical analysis was performed using R Studio, employing a random-effects model to generate pooled risk ratios (RRs) and 95% confidence intervals (CIs). Statistical heterogeneity was quantified using the I2 statistic.
Results
Six RCTs met the inclusion criteria, encompassing a total of 12,109 patients (6,088 assigned to BES and 6,021 to SES). Within the early-term follow-up (> 1 year), BES demonstrated a superior safety profile, associated with a statistically significant 30% reduction in cardiac death compared to SES (RR 0.70; 95% CI 0.52–0.93; p = 0.015; I2 = 0%). BES also showed a trend toward lower all-cause mortality, with a 19% reduction that approached but did not reach statistical significance (RR 0.81; 95% CI 0.64–1.01; p = 0.058; I2 = 0%).For the mid-term analysis (1 to 5 years), data from three trials involving 6,111 patients (3,063 BES; 3,048 SES) were available. In this period, the early advantage stabilized; no significant differences were observed between BES and SES for all-cause death (RR 1.09; 95% CI 0.93–1.28; p = 0.283; $I^2$ = 0%) or cardiac death (RR 1.09; 95% CI 0.85–1.40; p = 0.495; I2 = 0%). Across all outcomes, heterogeneity remained remarkably low, indicating high consistency in the therapeutic effect across the included trials.
CONCLUSIONS
Biolimus-eluting stents provide a significant short-term survival benefit, specifically reducing cardiac mortality within the first year following PCI compared to sirolimus-eluting stents. This early advantage suggests improved vascular healing or reduced early thrombotic events with the biolimus platform. Beyond the first year, clinical mortality outcomes remain comparable between the two technologies. While these findings confirm the safety and early efficacy of BES, the equilibration of outcomes at mid-term follow-up underscores the need for larger prospective studies with extended surveillance to determine if specific high-risk subgroups continue to derive a long-term benefit from BES over SES.
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