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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Long-term outcomes of patients receiving drug-eluting stents
Andrew C Philpott1, Danielle A Southern, Fiona M Clement
1Department of Medicine, University of Calgary, Calgary, Alberta.
Insights
Drug-eluting stents show initial safety and effectiveness in the first year post-implantation compared to bare-metal stents. However, long-term risks may increase, warranting further investigation into late adverse events.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-eluting stents (DES) aim to improve outcomes compared to bare-metal stents (BMS).
- Long-term safety data in real-world settings are crucial for clinical decision-making.
- Usual care settings provide valuable insights into stent performance.
Purpose of the Study:
- To compare the long-term safety and efficacy of DES versus BMS.
- To evaluate rates of death and repeat revascularization over a 3-year follow-up period.
- To assess stent performance in a large, consecutive patient cohort.
Main Methods:
- Prospective multicentre registry analysis.
- Inclusion of 6440 patients undergoing angioplasty with DES or BMS.
- 3-year follow-up for mortality and repeat revascularization events.
Main Results:
- DES were implanted in 1120 patients, BMS in 5320, with DES patients having higher comorbidity burden.
- In year 1, DES showed lower mortality (3.0% vs 3.7%) and composite outcome (12.0% vs 15.8%) rates.
- From year 2 onwards, risk profiles shifted, with higher relative risks for composite outcomes with DES compared to BMS.
Conclusions:
- Drug-eluting stents demonstrate safety and effectiveness within the first year post-procedure.
- Potential for increased adverse events with drug-eluting stents in later years (2-3) cannot be excluded.
- Long-term surveillance is essential for understanding the evolving risk-benefit profile of DES.
Background:
We sought to establish the long-term safety of drug-eluting stents compared with bare-metal stents in a usual care setting.
Methods:
Using data from a prospective multicentre registry, we compared rates of death and of death or repeat revascularization during 3 years of follow-up of 6440 consecutive patients who underwent angioplasty with either drug-eluting or bare-metal stents between Apr. 1, 2003, and Mar. 31, 2006.
Results:
Drug-eluting stents were inserted in 1120 patients and bare-metal stents in 5320. The drug-eluting stents were selected for patients who had a greater burden of comorbid illness, including diabetes mellitus (32.8% v. 20.8% in the bare-metal group, p < 0.001) and renal disease (7.4% v. 5.0%, p = 0.001). At 1-year follow-up, the drug-eluting stents were associated with a mortality of 3.0%, as compared with 3.7% with the bare-metal stents (adjusted odds ratio [OR] 0.62, 95% confidence interval [CI] 0.46-0.83). The rate of the composite outcome of death or repeat revascularization was 12.0% for the drug-eluting stents and 15.8% for the bare-metal stents (adjusted OR 0.40, 95% CI 0.33-0.49). In the subgroup of patients who had acute coronary syndromes, the adjusted OR for this composite outcome was 0.46 (95% CI 0.35-0.61). During the 3 years of observation, the relative risks for death and repeat revascularization varied over time. In year 1, there was an initial period of lower risk in the group with drug-eluting stents than in the group with bare-metal stents; this was followed by a shift toward outcome rates favouring bare-metal stents in years 2 and 3. The adjusted relative risk of the composite outcome of death or repeat revascularization associated with drug-eluting stents relative to bare-metal stents was 0.73 early in the first year of follow-up; it then rose gradually over time, to a peak of 2.24 at 3 years.
Interpretation:
Drug-eluting stents are safe and effective in the first year following insertion. Thereafter, the possibility of longer term adverse events cannot be ruled out.