NORSTENT
Trial question
What is the effect of drug-eluting stents in patients with stable or unstable coronary artery disease undergoing PCI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 9013
9013 patients (2256 female, 6757 male).
Inclusion criteria: patients who had stable or unstable coronary artery disease who were undergoing PCI.
Key exclusion criteria: previous treatment with coronary stent, bifurcation lesion requiring treatment with a two-stent technique, serious medical condition other than coronary artery disease with life expectancy < 5 years, intolerable side-effects to any drug in use during PCI or contraindications to long-term dual-antiplatelet therapy or had been prescribed warfarin.
Interventions
N=4504 drug-eluting stents (everolumus- and zotarolumus-eluting stents).
N=4509 bare-metal stents (contemporary devices with thin struts).
Primary outcome
All-cause death and nonfatal spontaneous MI at 6 years
16.6%
17.1%
17.1 %
12.8 %
8.6 %
4.3 %
0.0 %
Drug-eluting
stents
Bare-metal
stents
No significant
difference ↔
No significant difference in all-cause death and nonfatal spontaneous MI at 6 years (16.6% vs. 17.1%; HR 0.98, 95% CI 0.88 to 1.09).
Secondary outcomes
Significant decrease in any repeat revascularization at 6 years (16.5% vs. 19.8%; HR 0.76, 95% CI 0.69 to 0.85).
Conclusion
In patients who had stable or unstable coronary artery disease who were undergoing PCI, drug-eluting stents were not superior to bare-metal stents with respect to a all-cause death and nonfatal spontaneous MI at 6 years.
Reference
Bonaa KH, Mannsverk J, Wiseth R et al. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016 Sep 29;375(13):1242-52.
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