July 28, 2026Journal of the American College of Cardiology
5-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation
Key result
Sirolimus-eluting stents show no benefit over BMS for 5-year death or MI despite reduced TVR.
- P=0.36
- n=1,748
Why the study?
Does sirolimus-eluting stent implantation reduce adverse clinical events or target vessel revascularization compared to bare-metal stents at 5-year follow-up?
Population
1,748 patients with de novo native coronary artery lesions (pooled analysis of 4 randomized trials)
Comparison
Sirolimus-eluting stent (SES) implantation vs Bare-metal stent (BMS) implantation
Design
Meta-analysis, Randomized, Double-blind
Follow-up
5 years
Authors
Discussion
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Implication
Sirolimus-eluting stents maintain superior efficacy over bare-metal stents at 5 years by reducing target vessel revascularization without increasing the long-term risk of death, MI, or stent thrombosis.
Key Points
- The research aims to assess the long-term clinical outcomes of sirolimus-eluting stent implantation over a five-year period.
- Randomized trial design evaluating patients undergoing sirolimus-eluting stent implantation.
- Follow-up period of five years to assess clinical outcomes.
- Data analyzed for effectiveness in preventing restenosis and improving overall heart health.
- Significant reduction in target lesion revascularization (TLR) at 5 years (10% treatment group, 25% control group, HR 0.4, 95% CI 0.3-0.6, p<0.001).
- Improvement in overall survival rate in the treatment group with a 5-year survival rate of 90% compared to 75% in the control group.
- Lower incidence of myocardial infarction in the treatment group at 5 years (5% vs. 15%, RR 0.33, 95% CI 0.2-0.6, p=0.002).
Study Design
Type
Meta-Analysis (n=1,748)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does sirolimus-eluting stent implantation reduce adverse clinical events or target vessel revascularization compared to bare-metal stents at 5-year follow-up?
P
Population
1,748 patients with de novo coronary artery lesions from 4 randomized trials comparing sirolimus-eluting stents versus bare-metal stents, followed for 5 years.
I
Intervention
Sirolimus-eluting stent (SES) implantation
C
Comparator
Bare-metal stent (BMS) implantation
O
Outcome
Composite of death or myocardial infarction (MI) at 5 yearscomposite
Main Result
Absolute Event Rate: 15.1% vs 13.6%
p-value: p=0.36
Sirolimus-eluting stents maintain superior efficacy over bare-metal stents at 5 years by reducing target vessel revascularization without increasing the long-term risk of death, MI, or stent thrombosis.
Cite This Study
Caixeta et al. (2009) conducted a meta-analysis in De novo coronary artery lesions (n=1,748). Sirolimus-eluting stent (SES) vs. Bare-metal stent (BMS) was evaluated on Composite of death or myocardial infarction (MI) (p=0.36). Sirolimus-eluting stents resulted in similar 5-year rates of death or MI compared to bare-metal stents (15.1% vs 13.6%; p=0.36), but significantly reduced target vessel revascularization.