Norwegian Coronary Stent Trial - NORSTENT

Description:

The goal of the trial was to evaluate treatment with a drug-eluting stent compared with a bare-metal stent among patients undergoing percutaneous coronary intervention (PCI).

Contribution to the Literature: NORSTENT showed no long-term reduction in death or myocardial infarction among patients treated with a drug-eluting stent.

Study Design

  • Randomized
  • Parallel

Patients with obstructive coronary artery disease were randomized to a drug-eluting stent (n = 4,504) versus a bare-metal stent (n = 4,509). Clopidogrel was recommended for 9 months after the procedure.

  • Total number of enrollees: 9013
  • Duration of follow-up: median 5 years
  • Mean patient age: 63 years
  • Percentage female: 25%
  • Percentage diabetics: 13%

Inclusion criteria:

  • Patients at least 18 years of age with stable angina or acute coronary syndrome
  • Undergoing PCI

Exclusion criteria:

  • Previous PCI
  • Planned bifurcation PCI
  • Limited life expectancy
  • Contraindication to long-term antiplatelet therapy
  • Receiving warfarin

Other salient features/characteristics:

  • 31% with non-ST-segment elevation myocardial infarction
  • 27% with ST-segment elevation myocardial infarction
  • Of the drug-eluting stent group, 95% received an everolimus or a zotarolimus-eluting stent

Principal Findings:

The primary outcome, incidence of death or myocardial infarction at a median of 5 years occurred in 16.6% of the drug-eluting stent group versus 17.1% of the bare-metal stent group (p = 0.66).

Secondary outcomes:

  • Target lesion revascularization: 5.3% versus 10.3%, respectively, for drug-eluting versus bare-metal stent groups (p < 0.001)
  • Any repeat revascularization: 16.5% versus 19.8%, respectively, for drug-eluting versus bare-metal stent groups (p < 0.001)
  • Definite stent thrombosis: 0.8% versus 1.2%, respectively, for drug-eluting versus bare-metal stent groups (p = 0.0498)
  • Quality-of-life measures: similar between the groups

Interpretation:

Among patients with obstructive coronary artery disease undergoing PCI, similar rates of long-term death or myocardial infarction were observed with drug-eluting stents versus bare-metal stents. Drug-eluting stents versus bare-metal stents were associated with an approximate 3% absolute reduction in repeat revascularization. Drug-eluting stents were also associated with a small, but significant reduction in stent thrombosis. While drug-eluting stents remain the treatment of choice for most PCI procedures, bare-metal stents can be safely used in select patients.

References:

Bønaa KH, Mannsverk J, Wiseth R, et al., on behalf of the NORSTENT Investigators. Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease. N Engl J Med 2016;Aug 30:[Epub ahead of print].

Editorial: Bates ER. Balancing the Evidence Base on Coronary Stents. N Engl J Med 2016;Aug 30:[Epub ahead of print].

Presented by Dr. Kaare Harald Bønaa at the European Society of Cardiology Congress, Rome, Italy, August 30, 2016.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: ESC Congress, Acute Coronary Syndrome, Angina Pectoris, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Thrombosis


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