NORSTENT

Bønaa et al report the NORSTENT randomized clinical trial of drug eluting stents (EES, ZES) versus bare metal stents in patients with stable or unstable angina.  The were no significant differences between the groups for all cause death or spontaneous non-fatal myocardial infarction. Repeat revascularization was lower in the drug eluting stent arm. Quality of life assessment was also not significantly different between the two groups.

Abstract

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.

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