article102

ASCEND (Aspirin)

"Aspirin for Primary Prevention in Diabetes Mellitus"

The New England Journal of Medicine. Date of publication not provided. PubMed•Full text•PDF

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 Outcomes
8.2 Secondary Outcome
9 Criticisms
10 Funding
11 Further Reading

Clinical Question

Does aspirin reduce the risk of serious vascular events in adults with diabetes who do not have evident cardiovascular disease?

Bottom Line

Aspirin use in persons with diabetes without evident cardiovascular disease reduced the risk of serious vascular events but increased the risk of major bleeding events. The benefits were largely counterbalanced by the bleeding hazard.

Major Points

The ASCEND trial assessed the efficacy and safety of aspirin in diabetes patients without cardiovascular disease. The study found a 12% reduction in serious vascular events with aspirin, but also a 29% increased risk for major bleeding events. The absolute benefits and risks were similar in magnitude, suggesting precise balance in this population.

Guidelines

Guidelines reflecting the results of this trial are not specified in the provided text.

Design

- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial
- N=15,480 adults with diabetes and no evident cardiovascular disease

Population

Inclusion Criteria:
- Diagnosis of diabetes mellitus (type not specified)
- No known cardiovascular disease
- Uncertainty surrounding benefit of antiplatelet therapy

Exclusion Criteria:
- Indication or contraindication for aspirin use
- Other significant conditions impacting adherence to 5-year regimen

Baseline Characteristics:
- Well-balanced between both groups
- Aspirin use prior to screening present in 35.6% of participants

Interventions

- Randomized to receive either 100 mg of aspirin once daily or matching placebo

Outcomes

Primary Outcomes:
- Serious vascular events (myocardial infarction, stroke or transient ischemic attack, death from vascular causes excluding intracranial hemorrhage): lower in aspirin group (8.5% vs 9.6% placebo)
- Major bleeding events (intracranial hemorrhage, eye bleeding, gastrointestinal bleeding, and other serious bleeding): higher in aspirin group (4.1% vs 3.2% placebo)

Secondary Outcome:
- Gastrointestinal tract cancer incidence: no significant difference between the aspirin and placebo groups
- Other cancers (fatal or nonfatal): no significant difference between groups

Criticisms

The provided text does not articulate specific criticisms of the trial.

Funding

Funded by the British Heart Foundation, Bayer (Germany and the United States), Solvay, Abbott, and Mylan. Trial drugs and matching placebo were provided by Bayer.