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Published on: October 26, 2016
Drug-eluting versus bare-metal stents in large coronary arteries
Christoph Kaiser1, Soeren Galatius, Paul Erne
1Department of Cardiology, University Hospital, CH 4031 Basel, Switzerland. ckaiser@uhbs.ch
Insights
Second-generation drug-eluting stents (DES) showed no increased risk of cardiac events compared to bare-metal stents in large coronary arteries. Both sirolimus-eluting and everolimus-eluting stents significantly reduced target-vessel revascularization rates.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- First-generation drug-eluting stents (DES) were linked to increased late cardiac events in large coronary arteries.
- Second-generation DES aim to improve safety and efficacy profiles.
- Assessing the comparative safety and effectiveness of second-generation DES versus bare-metal stents (BMS) is crucial.
Purpose of the Study:
- To confirm if first-generation DES pose a higher risk for late cardiac events.
- To evaluate if second-generation DES also present an increased risk compared to BMS.
- To compare the rates of death, myocardial infarction, and target-vessel revascularization between different stent types.
Main Methods:
- A randomized trial involving 2314 patients with large coronary arteries (≥3.0 mm diameter).
- Patients received sirolimus-eluting stents, everolimus-eluting stents, or bare-metal stents.
- Primary endpoint: composite of cardiac death or nonfatal myocardial infarction at 2 years. Secondary endpoints: late events and target-vessel revascularization.
Main Results:
- No significant differences in the primary endpoint (cardiac death/myocardial infarction) between DES and BMS groups.
- Similar rates of late events, death, myocardial infarction, and stent thrombosis across all stent types.
- Significantly lower target-vessel revascularization rates observed with both sirolimus-eluting and everolimus-eluting stents compared to BMS.
Conclusions:
- Second-generation DES (sirolimus-eluting and everolimus-eluting) are not associated with increased rates of death or myocardial infarction in large coronary arteries.
- Both second-generation DES demonstrated comparable and significant reductions in target-vessel revascularization versus BMS.
- These findings support the use of second-generation DES for improved revascularization outcomes without compromising safety.
Background:
Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether this increase in risk was also seen with second-generation drug-eluting stents.
Methods:
We randomly assigned 2314 patients needing stents that were 3.0 mm or more in diameter to receive sirolimus-eluting, everolimus-eluting, or bare-metal stents. The primary end point was the composite of death from cardiac causes or nonfatal myocardial infarction at 2 years. Late events (occurring during months 7 to 24) and target-vessel revascularization were the main secondary end points.
Results:
The rates of the primary end point were 2.6% among patients receiving sirolimus-eluting stents, 3.2% among those receiving everolimus-eluting stents, and 4.8% among those receiving bare-metal stents, with no significant differences between patients receiving either drug-eluting stent and those receiving bare-metal stents. There were also no significant between-group differences in the rate of late events or in the rate of death, myocardial infarction, or stent thrombosis. Rates of target-vessel revascularization for reasons unrelated to myocardial infarction were 3.7% among patients receiving sirolimus-eluting stents, 3.1% among those receiving everolimus-eluting stents, and 8.9% among those receiving bare-metal stents. The rate of target-vessel revascularization was significantly reduced among patients receiving either drug-eluting stent, as compared with a bare-metal stent, with no significant difference between the two types of drug-eluting stents.
Conclusions:
In patients requiring stenting of large coronary arteries, no significant differences were found among sirolimus-eluting, everolimus-eluting, and bare-metal stents with respect to the rate of death or myocardial infarction. With the two drug-eluting stents, similar reductions in rates of target-vessel revascularization were seen. (Funded by the Basel Cardiovascular Research Foundation and the Swiss National Foundation for Research; Current Controlled Trials number, ISRCTN72444640.).
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