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Updated: Mar 7, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents
Anders M Galløe1, Henning Kelbæk1, Leif Thuesen2
1Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
Insights
First-generation drug-eluting stents (DES) showed stable long-term safety and efficacy over 10 years. Annual rates of major adverse cardiac events and stent thrombosis remained constant, indicating no late changes requiring extraordinary medical attention.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- First-generation drug-eluting stents (DES) were introduced to reduce in-stent restenosis but raised concerns about late stent thrombosis.
- Long-term clinical outcomes data are crucial for understanding the sustained safety and efficacy of early DES.
- Assessing 10-year event rates helps identify potential late safety signals.
Purpose of the Study:
- To evaluate the 10-year clinical outcomes of patients treated with first-generation DES in a large randomized trial.
- To detect any late changes in annual event rates for major adverse cardiac events (MACE) and stent thrombosis.
- To inform clinical practice regarding the long-term management of patients with first-generation DES.
Main Methods:
- A total of 2,098 unselected patients were randomized to receive either a sirolimus-eluting stent or a paclitaxel-eluting stent.
- The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, or target vessel revascularization.
- Stent thrombosis rates were also meticulously recorded and analyzed over the 10-year follow-up period.
Main Results:
- After 10 years, 73.1% of patients survived. The cumulative MACE rates were similar between sirolimus-eluting and paclitaxel-eluting stents (32.5% vs. 33.1%, HR 0.96).
- The annual MACE rate remained steady at 2.6% after the first year.
- Stent thrombosis occurred in 13.3% of patients, with no significant difference between stent types and a steady annual rate of 1.3% after the first year.
Conclusions:
- First-generation DES demonstrated consistent long-term safety and efficacy over a 10-year period.
- Annual rates of MACE and stent thrombosis remained constant, showing no late catch-up phenomenon.
- While no extraordinary medical surveillance is needed, continuous monitoring is advised due to the absence of declining event rates.
Background:
First-generation drug-eluting coronary stents (DES) were introduced in 2003 to 2004, and their use resulted in a considerable reduction in the development of in-stent restenosis at the cost of an increased risk of late stent thromboses.
Objectives:
This study followed clinical outcomes of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention.
Methods:
A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES implanted. This study recorded the occurrence of a major adverse cardiac event (MACE) assessed as the composite of cardiac death, myocardial infarction, and target vessel revascularization. Stent thromboses were also assessed.
Results:
Of the 2,098 unselected patients, 73.1% were still alive after 10 years. During the follow-up period, MACE occurred in 346 (32.5%) in the group receiving a sirolimus-eluting stent and in 342 (33.1%) in the group receiving a paclitaxel-eluting stent (hazard ratio: 0.96; 95% confidence interval: 0.83 to 1.11; p = 0.60), with a steady annual rate of 2.6% after the first year. Definite, probable, and possible stent thrombosis appeared in 279 patients (13.3%), with no difference between stent types and with a steady annual rate of 1.3% after the first year.
Conclusions:
Among the surviving patients, the long-term annual MACE rate and the stent thrombosis rate appeared constant for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT00388934).
