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Updated: Jul 3, 2026

A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Late adverse events after drug-eluting stent implantation
David F Kong1, Eric L Eisenstein, Robert Harrington
1Duke Clinical Research Institute, DUMC Box 3850, Durham, NC 27710, USA. David.F.Kong@duke.edu
Insights
Drug-eluting stents (DES) initially reduced repeat procedures for coronary artery revascularization. However, long-term data revealed risks of late stent thrombosis, prompting further investigation into DES safety and efficacy.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-eluting stents (DES) are crucial for preventing restenosis after percutaneous coronary artery revascularization.
- Initial randomized trials in low-risk patients supported the regulatory approval of DES.
- Concerns regarding late stent thrombosis emerged from long-term outcome meta-analyses in 2006.
Purpose of the Study:
- To critically appraise the late adverse effects associated with drug-eluting stents.
- To evaluate the strengths and limitations of various evidence sources, including registries, clinical trials, and meta-analyses.
- To highlight the collaborative efforts in generating robust evidence for DES safety.
Main Methods:
- Appraisal of long-term outcomes from randomized trials and meta-analyses.
- Analysis of data from large national registries.
- Review of evidence from focused, well-conducted clinical trials.
Main Results:
- Drug-eluting stents (DES) demonstrated efficacy in preventing restenosis but raised concerns about late stent thrombosis (>9 months post-procedure).
- Large national registries, clinical trials, and meta-analyses provide critical insights into DES performance.
- Evidence synthesis reflects a convergence of academic, industry, and public health interests.
Conclusions:
- Long-term safety surveillance is essential for understanding the full impact of medical devices like DES.
- The interplay between different study designs (registries vs. trials) is crucial for comprehensive evidence generation.
- Robust evidence bases are vital for informed clinical decision-making and public health policy regarding cardiovascular interventions.
Abstract:
Stents that elute antiproliferative drugs prevent restenosis after percutaneous coronary artery revascularization, reducing the need for repeat procedures. Randomized trials in low-risk patients supported initial regulatory approval for drug-eluting stents (DES). In 2006, meta-analyses of long-term outcomes from these trials associated DES use with adverse events, believed to be attributable to late stent thrombosis, occurring more than 9 months after the initial procedure. This article appraises these late adverse effects and illustrates the power and shortcomings of large national registries, focused, well-conducted clinical trials, and meta-analyses of clinical trial data. This timely, robust evidence base reflects an alignment of academic, industry, and public health priorities.
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