Potential Implications of NORSTENT (Norwegian Coronary Stent Trial) in Contemporary Practice
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In the NORSTENT study (Norwegian Coronary Stent Trial), comparing contemporary bare-metal stents (BMS) and second-generation drug-eluting stents (DES) in patients with stable or unstable coronary artery disease, DES were not superior to BMS for the reduction of death or myocardial infarction, nor did DES improve quality of life.1 NORSTENT demonstrated that current BMS outcomes are substantially better than expected, and patients do not live longer or better with DES.
NORSTENT was conducted to assess the long- term risks and benefits of DES versus BMS. At the time the trial was designed, there were major concerns regarding safety with DES because of the potential increased risk for stent thrombosis. A trial assessing hard end points at long-term follow-up was needed.
NORSTENT compared DES with BMS in a pragmatic, inclusive, non–industry-supported randomized trial. Of the 20 663 patients undergoing percutaneous coronary intervention in Norway from 2008 to 2011, a total of 12 425 met the inclusion criteria, and 9013 (72.5%) were randomly assigned to receive either DES or BMS. After 6 years of follow-up, there were no significant between-group differences in the primary composite outcome of death from any cause or nonfatal spontaneous myocardial infarction, nor were there differences in the individual end points of myocardial infarction or unstable angina. Measures of quality of life did not differ. The need for any repeat revascularization was low in both groups. During 6 years of follow-up, any repeat revascularization occurred in 19.8% of patients in the …