Norwegian Coronary Stent Trial - NORSTENT
The goal of the trial was to evaluate treatment with a drug-eluting stent compared with a bare-metal stent among patients undergoing percutaneous coronary intervention (PCI).
Contribution to the Literature: NORSTENT showed no long-term reduction in death or myocardial infarction among patients treated with a drug-eluting stent.
Patients with obstructive coronary artery disease were randomized to a drug-eluting stent (n = 4,504) versus a bare-metal stent (n = 4,509). Clopidogrel was recommended for 9 months after the procedure.
- Total number of enrollees: 9013
- Duration of follow-up: median 5 years
- Mean patient age: 63 years
- Percentage female: 25%
- Percentage diabetics: 13%
- Patients at least 18 years of age with stable angina or acute coronary syndrome
- Undergoing PCI
- Previous PCI
- Planned bifurcation PCI
- Limited life expectancy
- Contraindication to long-term antiplatelet therapy
- Receiving warfarin
Other salient features/characteristics:
- 31% with non-ST-segment elevation myocardial infarction
- 27% with ST-segment elevation myocardial infarction
- Of the drug-eluting stent group, 95% received an everolimus or a zotarolimus-eluting stent
The primary outcome, incidence of death or myocardial infarction at a median of 5 years occurred in 16.6% of the drug-eluting stent group versus 17.1% of the bare-metal stent group (p = 0.66).
- Target lesion revascularization: 5.3% versus 10.3%, respectively, for drug-eluting versus bare-metal stent groups (p < 0.001)
- Any repeat revascularization: 16.5% versus 19.8%, respectively, for drug-eluting versus bare-metal stent groups (p < 0.001)
- Definite stent thrombosis: 0.8% versus 1.2%, respectively, for drug-eluting versus bare-metal stent groups (p = 0.0498)
- Quality-of-life measures: similar between the groups
Among patients with obstructive coronary artery disease undergoing PCI, similar rates of long-term death or myocardial infarction were observed with drug-eluting stents versus bare-metal stents. Drug-eluting stents versus bare-metal stents were associated with an approximate 3% absolute reduction in repeat revascularization. Drug-eluting stents were also associated with a small, but significant reduction in stent thrombosis. While drug-eluting stents remain the treatment of choice for most PCI procedures, bare-metal stents can be safely used in select patients.
Bønaa KH, Mannsverk J, Wiseth R, et al., on behalf of the NORSTENT Investigators. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med 2016;Aug 30:[Epub ahead of print].
Editorial: Bates ER. Balancing the Evidence Base on Coronary Stents. N Engl J Med 2016;Aug 30:[Epub ahead of print].
Presented by Dr. Kaare Harald Bønaa at the European Society of Cardiology Congress, Rome, Italy, August 30, 2016.
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