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Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease
Kaare H Bønaa1, Jan Mannsverk1, Rune Wiseth1
1From the Department of Community Medicine (K.H.B., I.N., T.W.) and the Department of Clinical Medicine (T.S., T.A.H., K.R.), University of Tromsø-the Arctic University of Norway, and the Department of Cardiology, University Hospital of North Norway (J.M., T.T., T.S., T.A.H., Ø.D.-E., K.R.), Tromsø, the Departments of Public Health and General Medicine (K.H.B.) and Circulation and Medical Imaging (R.W.), Norwegian University of Science and Technology, and the Clinic for Heart Disease, St. Olav's University Hospital (K.H.B., R.W., M.S.), Trondheim, the Departments of Cardiology (L.A., B.B., E.F.), Radiology, (N.-E.K.), and Heart Disease (R.B.), Oslo University Hospital, and the Faculty of Medicine, University of Oslo (N.-E.K., B.B.), Oslo, the Department of Cardiology, Feiring Heart Clinic, Feiring (Y.M., S.S.), the Department of Heart Disease, Haukeland University Hospital (O.N., Ø.B.), and the Department of Clinical Science, University of Bergen (O.N., D.W.N., A.-I.L., J.E.N.), Bergen, the Department of Cardiology, Stavanger University Hospital, Stavanger (D.W.N., A.-I.L., J.E.N.), and the Department of Medicine, Sørlandet Hospital, Arendal (M.U., O.J.J.) - all in Norway.
Insights
Drug-eluting stents and bare-metal stents showed similar long-term outcomes for death and heart attack. However, drug-eluting stents significantly reduced repeat revascularization rates in patients undergoing percutaneous coronary intervention (PCI).
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials in Medicine
Background:
- Limited long-term data exist comparing contemporary drug-eluting stents (DES) and bare-metal stents (BMS).
- Key outcomes include mortality, myocardial infarction, repeat revascularization, stent thrombosis, and quality of life.
Purpose of the Study:
- To compare the long-term efficacy and safety of DES versus BMS.
- To evaluate differences in major adverse cardiac events and patient-reported outcomes.
Main Methods:
- A randomized trial involving 9013 patients with coronary artery disease.
- Patients received either contemporary DES (everolimus- or zotarolimus-eluting) or BMS during percutaneous coronary intervention (PCI).
- Primary outcome: composite of all-cause death and nonfatal spontaneous myocardial infarction at 5 years; secondary outcomes: repeat revascularization, stent thrombosis, quality of life.
Main Results:
- No significant difference in the primary composite outcome (16.6% for DES vs. 17.1% for BMS) at 6 years.
- Significantly lower rates of repeat revascularization with DES (16.5%) compared to BMS (19.8%).
- Similar quality of life and no significant difference in stent thrombosis rates between the groups.
Conclusions:
- Contemporary DES and BMS show comparable long-term safety regarding death and myocardial infarction.
- DES demonstrate a significant benefit in reducing the need for repeat revascularization compared to BMS.
- The findings support the use of DES for improved long-term outcomes in PCI procedures.
Background:
Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life.
Methods:
We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life.
Results:
At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups.
Conclusions:
In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).
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