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