Potential Implications of NORSTENT (Norwegian Coronary Stent Trial) in Contemporary Practice
Authors: Rune Wiseth, Kaare Harald Bønaa
Journal: Circulation (2017)

n 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-industrysupported 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 BMS versus 16.5% of patients in the DES group (3.3% absolute risk reduction; P<0.001).The difference was driven, as expected, by less restenosis with DES.Based on these figures, the number needed to treat with DES to prevent 1 revascularization is 30.In summary, during 6 years of follow-up, BMS delivered the same hard outcomes and the same quality of life as DES, and, for 96.7% of the patients, BMS also delivered the same results for repeat revascularization.NORSTENT thus showed that the vast majority of patients had the same long-term results regardless of whether they received BMS or DES.The main results of NORSTENT were robust across subgroups defined by sex, age, medical history, clinical presentation, and lesion complexity.European guidelines state that "Compared with bare-metal stents and earlygeneration DES, new-generation DES have also improved safety outcomes including death, myocardial infarction…," and the guidelines recommend DES as a default strategy because of their higher efficacy in preventing repeat revascularization. 2 NORSTENT demonstrates that a major premise for this recommendation, ie, improved safety with DES versus BMS, does not hold.Bleeding is an additional safety consideration, and the optimal duration of dual antiplatelet therapy (DAPT) following DES is still a matter of debate.In NORSTENT, the duration of DAPT was similar in both groups to assess device performance, thus depriving the BMS group the reduced risk of bleeding with Potential Implications of NORSTENT (Norwegian Coronary Stent Trial) in Contemporary Practice