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Updated: May 6, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions
Antonio Colombo1, Jeffrey W Moses, Marie Claude Morice
1EMO Centro Cuore Columbus, Milan, Italy.
Insights
Sirolimus-eluting stents showed improved outcomes for coronary bifurcation lesions compared to bare metal stents, but restenosis remains a concern. Further study is needed to determine the optimal stenting technique for these complex lesions.
Area of Science:
- Interventional Cardiology
- Cardiovascular Devices
- Medical Technology
Background:
- Sirolimus-eluting stents (Cypher) effectively reduce restenosis in select coronary lesions.
- Higher-risk lesions, such as coronary bifurcations, have not been extensively studied with these stents.
Purpose of the Study:
- To evaluate the safety and efficacy of sirolimus-eluting stents in treating coronary bifurcation lesions.
- To compare two stenting strategies: double stenting versus main branch stenting with provisional side branch stenting.
Main Methods:
- Prospective study enrolling 85 patients (86 lesions) with coronary bifurcation lesions.
- Random assignment to either double stenting (Group A) or main branch with provisional side branch stenting (Group B).
- Clinical and angiographic follow-up at 6 months.
Main Results:
- Overall restenosis rate at 6 months was 25.7%, not significantly different between groups (double stenting 28.0%, provisional SB-stenting 18.7%).
- Stent thrombosis occurred in 3.5% of patients.
- Target lesion revascularization in 7 cases and target vessel failure in 17.6%.
Conclusions:
- Sirolimus-eluting stent use in bifurcations shows improvement over historical bare metal stent controls.
- Restenosis at the side branch ostium remains a significant challenge.
- The optimal technique for treating bifurcations with Cypher stents requires further investigation.
Background:
A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied.
Methods And Results:
This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%).
Conclusions:
These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.
