In our evaluation of clinical outcomes in 9013 patients with stable or unstable coronary artery disease, we found no significant difference in the 6-year rates of death or spontaneous myocardial infarction between patients receiving contemporary drug-eluting stents and those receiving bare-metal stents.
NORSTENT
Project period: Active since 2012, data collection 2008-2016.
The Norwegian Coronary Stent Trial (NORSTENT) was a multicenter, randomized trial conducted at all eight centers in Norway that perform percutaneous coronary intervention (PCI). The trial protocol is available with the full text of this article at NEJM.org. The trial was funded by the Norwegian Research Council and other not-for-profit organizations.
From September 15, 2008, to February 14, 2011, a total of 20,663 patients underwent PCI in Norway. Of the 12,425 patients who were eligible to participate in the trial, 9013 (72.5%) underwent randomization.
At 6 years, the rate of the primary composite outcome of death from any cause and nonfatal spontaneous myocardial infarction was 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% CI, 0.88 to 1.09, p=0.66).
The results for the primary outcome were consistent in subgroups defined according to demographic, clinical, lesion, and procedural characteristics.
In the main publication in New England Journal of Medicine (2016) the NORSTENT trial concluded that there was no significant difference between contemporary drug-eluting stents and bare-metal stents in the rates of death from any cause or nonfatal spontaneous myocardial infarction during 6 years of follow-up. The rate of repeat revascularization was significantly lower in the group receiving drug-eluting stents, which showed the durability of this effect over 6 years. Rates of definitive stent thrombosis were low in both groups and appeared to be lower in the group receiving drug-eluting stents than in the group receiving bare-metal stents (p=0.0498). The type of stent had no significant effect on quality of life, as assessed by means of the Seattle Angina Questionnaire.
After the main article published in 2016 there have been several other pulications from the NORSTENT trial, as listed below.
Members
Kaare H Bønaa (Principal investigator)
Jan Erik Nordrehaug
Inger Njølstad
Jan Mannsverk
Tom Wilsgaard
For the NORSTENT Investigators
Publications
- Mølstad P, Nordrehaug JE, Steigen T, Wilsgaard T, Wiseth R, Bønaa KH. Analyses of Increased Mortality in New and Known Diabetes in Patients with Coronary Disease Enrolled in the NORSTENT Randomized Study. Cardiology. 2021;146(3):295-303. doi: 10.1159/000513514.
- Samuelsen PJ, Eggen AE, Steigen T, Wilsgaard T, Kristensen A, Skogsholm A, Holme E, van den Heuvel C, Nordrehaug JE, Bendz B, Nilsen DWT, Bønaa KH. Incidence and risk factors for major bleeding among patients undergoing percutaneous coronary intervention: Findings from the Norwegian Coronary Stent Trial (NORSTENT). PLoS One. 2021;16(3):e0247358. doi: 10.1371/journal.pone.0247358.
- Olsen SJ, Schirmer H, Wilsgaard T, Bønaa KH, Hanssen TA. Employment status three years after percutaneous coronary intervention and predictors for being employed: A nationwide prospective cohort study. Eur J Cardiovasc Nurs. 2020;19(5):433-439. doi: 10.1177/1474515120903614.
- Mølstad P, Nordrehaug JE, Steigen T, Giil LM, Wilsgaard T, Wiseth R, Bønaa KH. The Effect of Drug-Eluting Stents on Target Lesion Revascularization in Native Coronary Arteries: Results from the NORSTENT Randomized Study. Cardiology. 2020;145(6):333-341. doi: 10.1159/000506042
- Wiseth R, Bønaa KH. Potential Implications of NORSTENT (Norwegian Coronary Stent Trial) in Contemporary Practice. Circulation. 2017;136(8):701-703. doi: 10.1161/CIRCULATIONAHA.116.025946.
- Bønaa KH, Mannsverk J, Wiseth R, Aaberge L, Myreng Y, Nygård O, Nilsen DW, Kløw NE, Uchto M, Trovik T, Bendz B, Stavnes S, Bjørnerheim R, Larsen AI, Slette M, Steigen T, Jakobsen OJ, Bleie Ø, Fossum E, Hanssen TA, Dahl-Eriksen Ø, Njølstad I, Rasmussen K, Wilsgaard T, Nordrehaug JE; NORSTENT Investigators. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med. 2016;375(13):1242-52. doi: 10.1056/NEJMoa1607991.