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Updated: Jun 30, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Long-term efficacy and safety of sirolimus-eluting vs bare-metal stents
Raymond G McKay1, Deborah J Murphy, Jill Cloutier
1Division of Interventional Cardiology, Hartford Hospital Cardiac Laboratory, 80 Seymour Street, Hartford CT 06115, USA. rmckay@harthosp.org
Insights
Sirolimus-eluting stents (SES) show improved long-term survival and reduced repeat procedures compared to bare metal stents (BMS). This study confirms SES safety and efficacy in real-world use, even for off-label indications.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Previous studies suggest sirolimus-eluting stents (SES) offer clinical benefits, but long-term safety and efficacy in routine practice, including off-label use, remain unclear.
- The CYPHER stent is a type of SES.
- Bare metal stents (BMS) serve as a comparator for evaluating SES performance.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of SES (CYPHER stent) in routine clinical practice.
- To compare clinical outcomes between SES and BMS, including patients with off-label stent implantation.
- To assess the impact of SES on all-cause mortality, myocardial infarction (MI), and repeat target vessel revascularization over a five-year follow-up period.
Main Methods:
- A comparative study involving 2,550 patients treated with SES and 1,022 patients treated with BMS.
- Inclusion of patients with off-label stent indications in both SES (41.5%) and BMS (47.7%) groups.
- Utilized propensity-score matching to adjust for baseline characteristic differences and followed patients for up to five years.
Main Results:
- SES use was associated with significantly improved event-free survival regarding all-cause mortality (RR, 1.39) and repeat target vessel revascularization (RR, 2.72) compared to BMS.
- No significant difference was observed in the incidence of cumulative myocardial infarction (MI) between SES and BMS groups.
- Late hazard analysis (≥6 months post-implantation) showed no increased risk associated with SES use (relative risk, 1.08).
Conclusions:
- Sirolimus-eluting stent (SES) use in clinical practice, including off-label indications, demonstrates improved long-term mortality.
- SES significantly reduces the need for repeat target vessel revascularization compared to bare metal stents (BMS).
- Long-term data indicate no increased risk of myocardial infarction (MI) with SES compared to BMS.
Background:
Although previous studies have documented persistent clinical benefit of sirolimus-eluting stents (SES)in reducing the need for target vessel revascularization without an increase in myocardial infarction (MI) or mortality, the long-term safety and efficacy of CYPHER stent use in routine clinical practice, including off-label stent implantation, remains uncertain.
Methods:
We compared long-term clinical outcomes in 2,550 patients treated with one or more SES with 1,022 patients treated with one or more bare metal or heparin-coated stents (BMS). The study groups included 1,058 SES patients (41.5%) and 488 BMS patients (47.7%) with off-label indications. A propensity-score method was utilized to adjust for differences in baseline characteristics. Patients were followed for up to five years for the occurrence of all-cause mortality, MI and repeat target vessel revascularization.
Results:
Compared to BMS patients, SES patients demonstrated significantly improved event-free survival with respect to all-cause mortality (RR, 1.39; 95% CI, 1.07 to 1.80, P = 0.014) and repeat target vessel revascularization (RR, 2.72; 95% CI, 1.99 to 3.73, P < 0.001), with no significant difference in the incidence of cumulative MI. A landmark analysis, examining composite adverse events occurring six months after stent implantation in the two study groups, demonstrated no increased late hazard associated with SES use (relative risk, 1.08; 95% CI, 0.80 to 1.46).
Conclusions:
Use of SES in routine clinical practice, including off-label indications, is associated with improved long-term mortality, reduced need for repeat target vessel revascularization and no increase in MI compared to BMS.
