NORSTENT - Drug-eluting versus bare-metal stent for CAD (short)

Bonaa KH, et al. Drug-eluting or bare-metal stents for coronary artery disease. N Engl J Med 2016 [online]

Bottom-line: In patients with CAD who received PCI with coronary stent placement and received DAPT with ASA + clopidogrel x9 months, there were no difference in death or MI whether patients received 2nd-gen drug-eluting stents or bare-metal stents. 

Drug-eluting stents reduced the need for further revascularization by 3.3% (absolute) at 6 years.

Also worth mentioning: Regardless of stent type implanted, patients received 9 months of dual-antiplatelet therapy (DAPT; with clopidogrel). Despite this, patients with drug-eluting stents had lower risk of stent thrombosis than those with bare-metal stents. Combined with the evidence showing no statistically-significant difference in stent thrombosis risk between 3 vs 12 months of DAPT in patients with 2nd-generation drug-eluting stents, this provides evidence against using bare-metal stents in patients with increased risk of bleeding to permit shorter DAPT duration.



Patients (n=9013)

  • Multicenter (all 8 Norwegian PCI cneters); every person who got PCI in Norway Sept 2008-Feb 2014 potentially eligible for this trial
  • Inclusion:
    • Adults presenting with stable angina or ACS with lesion in native coronary arteries or coronary-artery grafts amenable to stent implantation
  • Exclusion:
    • Previous coronary stent
    • Bifurcation lesion requiring 2+ stent technique
    • On warfarin
    • Life expectancy <5 y due to condition other than CAD
  • 12,425 eligible -> 9013 randomized
  • Average patient
    • 63 y/o
    • Male 75%
    • Smoker ~35%
    • Diabetes ~13%
    • PCI indication: stable angina 30%, UA 12%, NSTEMI 31%, STEMI 27%
    • Multivessel disease 40%
    • Procedure characteristics: 1-2 stents implanted, total length ~27 mm


  • I: Drug-eluting stent (DES)
    • ost common: Everolimus-eluting (Promus 67%, Xience 15%), zotarolimus-eluting (Endeavor Resolute 11%)
  • C: Bare-metal stent (BMS)
    • Most common: Driver 43%, Integrity 22%, Liberte 18%)
  • Co-interventions common to both groups:
    • ASA 75 mg/d indefinitely
    • Clopidogrel 75 mg/d x9 months
    • Other secondary prevention therapy per current guidelines

Results @ ~6 years

  • No significant difference in primary outcome (death, non-fatal spontaneous MI)
    • DES 16.6% vs BMS 17.1% (p=0.66)
  • Other non-significant secondary outcomes:
    • Death: 8.5% vs 8.4%
    • Spontaneous MI: 11.4% vs 12.5%
    • Stroke: 3.4% vs 3.0%
  • Statistically-significantly different secondary outcomes:
    • Any revascularization (CABG or PCI): 16.5% vs 19.8% (p<0.001, number needed to treat 31 at 6 years)
    • Definite stent thrombosis: 0.8% vs 1.2% (p=0.05)

Issue with internal validity?

  • No: Allocation-concealed, open-label RCT analyzing intention-to-treat population, 0% lost-to-follow-up
    • Low risk of allocation, performance, detection or attrition bias