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Updated: Jul 16, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents
Adnan Kastrati1, Julinda Mehilli, Jürgen Pache
1Deutsches Herzzentrum, Technische Universität, Munich, Germany. kastrati@dhm.mhn.de
Background:
The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.
Methods:
We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.
Results:
The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.
Conclusions:
The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.
Insights
Sirolimus-eluting stents do not impact long-term survival or reduce myocardial infarction risk compared to bare-metal stents. However, they significantly decrease the need for reintervention, though stent thrombosis risk may be slightly higher long-term.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials in Medicine
Background:
- Long-term outcomes of sirolimus-eluting stents (SES) versus bare-metal stents (BMS) remain incompletely understood.
- Establishing comparative effectiveness is crucial for clinical decision-making in coronary artery stenting.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of SES compared to BMS.
- To assess the impact on overall mortality, myocardial infarction, stent thrombosis, and reintervention rates.
Main Methods:
- Meta-analysis of individual patient data from 14 randomized controlled trials.
- Inclusion of 4958 patients comparing SES with BMS.
- Follow-up intervals ranged from 12.1 to 58.9 months, analyzing primary and composite endpoints.
Main Results:
- No significant difference in all-cause mortality (HR 1.03) or the composite of death/myocardial infarction (HR 0.97) between SES and BMS.
- Significant reduction in the composite of death, myocardial infarction, or reintervention (HR 0.43) with SES.
- No significant difference in overall stent thrombosis (HR 1.09), but a potential slight increase after one year.
Conclusions:
- SES do not significantly affect long-term survival or myocardial infarction-free survival compared to BMS.
- SES demonstrate a sustained benefit in reducing the need for reintervention.
- The risk of stent thrombosis with SES is comparable to BMS, with a possible slight increase beyond the first year.
