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NORSTENT

"Long-term Outcomes with Drug-Eluting Stents versus Bare-Metal Stents in Norway".The New England Journal of Medicine. 2016. 375(13):1242-1252.

Links to original sources: Wiki Journal Post Full Journal Article

Contents

1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Funding 10 Further Reading

Clinical Question


In patients undergoing PCI, are there significant differences between contemporary drug-eluting stents and bare-metal stents in long-term outcomes?

Bottom Line


Among patients undergoing PCI, no significant difference was found in 6-year rates of death and nonfatal spontaneous myocardial infarction between those receiving contemporary drug-eluting stents and those receiving bare-metal stents. However, repeat revascularization rates were lower with drug-eluting stents.

Major Points


Drug-eluting stents are more effective in preventing restenosis than bare-metal stents, with possible reductions in thrombosis rates. The long-term risks and benefits of contemporary drug-eluting stents compared to bare-metal stents were assessed in NORSTENT, which is a large, randomized trial.

Guidelines


No specific guidelines discussed. Trial context suggests the use of either drug-eluting stents or bare-metal stents based on clinical judgment and patient preferences.

Design


Multicenter, randomized trial comparing contemporary drug-eluting stents and bare-metal stents in patients undergoing PCI for stable or unstable coronary artery disease.

Population


Inclusion Criteria: Men and women at least 18 years of age with stable angina or acute coronary syndrome, suitable for stent implantation, able to communicate in Norwegian, and provided informed consent. Exclusion Criteria: Prior coronary stent treatment, life expectancy less than 5 years from other medical conditions, participation in another trial, medication contraindication, or inability to follow protocol. Baseline Characteristics: Groups were well balanced with minor differences in total stent length, lesion type, and lesions in coronary-artery bypass grafts.

Interventions


Placement of either drug-eluting stents (primarily everolimus-eluting or zotarolimus-eluting) or bare-metal stents during PCI. Aspirin and clopidogrel were prescribed post-procedure for all patients.

Outcomes


Primary Outcome: Composite of death from any cause and nonfatal spontaneous myocardial infarction showed no significant difference at a 6-year follow-up. Secondary Outcomes: Any repeat revascularization was significantly lower in the drug-eluting stint group. Definite stent thrombosis rates were low and were potentially lower in the drug-eluting stint group. Quality of life, assessed by the Seattle Angina Questionnaire, did not differ significantly between groups.

Funding


The Norwegian Research Council and several not-for-profit organizations, with no sponsor role in the design or conduct of the study.

Further Reading


Details are provided in the full article link and listed under the NORSTENT on ClinicalTrials.gov, number NCT00811772.