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February 8, 2023JACC AdvancesOpen Access

Aspirin With or Without Statin in Individuals Without Atherosclerotic Cardiovascular Disease Across Risk Categories

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Key result

Aspirin cuts MI risk ~15% in primary prevention but increases major bleeding.

RR 0.85
95% CI 0.77-0.95
P<0.001
n=171,215

Figures

Graphical abstract published by JACC Advances — Graphical abstract · Published by JACC Advances · CC BY-NC-ND

Why the study?

The effects of aspirin in adults without ASCVD, stratified by statin use across different ASCVD risks, remained uncertain.

Does aspirin reduce myocardial infarction or increase major bleeding in adults without ASCVD across different ASCVD risk categories, stratified by statin use?

Study Design

Type

Meta-Analysis (n=171,215)

Structured PICO

Does aspirin reduce myocardial infarction or increase major bleeding in adults without ASCVD across different ASCVD risk categories, stratified by statin use?

P

Population

171,215 adults without established atherosclerotic cardiovascular disease, with a median age of 64 years and 46% female, followed for a median of 5 years.

I

Intervention

Aspirin (at least 75 mg every other day, mostly low dose ≤100 mg/d) with or without concomitant statin therapy.

C

Comparator

Placebo or no aspirin (control).

O

Outcome

Myocardial infarction (fatal and nonfatal) and major bleeding (bleeding requiring transfusion or hospitalization or leading to death) at maximum follow-up duration.hard clinical

Main Result

Relative Risk: 0.85 (95% CI 0.77–0.95)

p-value: p=<0.001

In adults without ASCVD, the absolute risk of major bleeding with aspirin exceeds the absolute MI benefits across all ASCVD risk levels, and concomitant statin therapy further diminishes the cardiovascular benefits of aspirin without reducing bleeding risk.

Limitations

Meta-analysis of trials with heterogeneous participants, variable outcome definitions, and follow-ups.
Prespecified subgroup analyses were conducted at the study level instead of the participant level due to a lack of individual data.
Absolute risk may vary across age groups, making the benefit-risk ratio uncertain in younger populations at high absolute risk.
Could not calculate individual ASCVD risk given the lack of information on the baseline variables of individual participants.
Meta-analysis of trials with heterogeneous participants, variable outcome definitions, and follow-ups
Prespecified subgroup analyses were conducted at the study level instead of the participant level due to a lack of individual data
Absolute risk may vary across age groups, making it uncertain if the benefit-risk ratio is more favorable in younger populations at high absolute risk
Could not calculate individual ASCVD risk given the lack of information on the baseline variables of individual participants

Implication

Bleeding risk with aspirin exceeds MI benefit without ASCVD; confirms net harm and supports avoiding routine primary prevention, especially with statins.

Abstract

The effects of aspirin in adults without atherosclerotic cardiovascular disease (ASCVD), stratified by statin use across different ASCVD risks, remain uncertain. The purpose of this study was to examine the effects of aspirin in adults without ASCVD, stratified by statin use across different ASCVD risks. We searched databases through March 2022 and selected randomized controlled trials of aspirin without ASCVD and follow-up of ≥1 year. We used random-effects models and estimated relative and absolute risks for cardiovascular outcomes, major bleeding, and mortality over 5 years. We calculated absolute risk differences assuming constant relative risks (RRs) across statin use and ASCVD risks. The Cholesterol Treatment Trialists Collaboration, and the ASCEND (A Study of Cardiovascular Events in Diabetes) trial were used to estimate baseline risks. In 16 trials [171,215 individuals; median age, 64 (Q1-Q3: 60-65) years], aspirin vs control reduced myocardial infarction (MI) [RR: 0.85 (95% CI: 0.77-0.95)] but increased major bleeding [RR: 1.48 (95% CI: 1.32-1.66)]. Aspirin did not reduce mortality. Statin vs no statin was associated with lower bleeding and MI risk; the bleeding and MI risk were proportional to ASCVD risk. For every 10,000 adults, aspirin reduced MI (very low risk: 3 events as monotherapy or 1 event with statin; very high risk: 49 events as monotherapy or 37 events with statin) and increased major bleeding (very low risk: 21 events as monotherapy or 20 events with statin; very high risk: 98 events as monotherapy or 94 events with statin) proportional to baseline ASCVD risk. In adults without ASCVD, concomitant statin appeared to significantly reduce absolute risk reduction for MI associated with aspirin without influencing bleeding risk. The anticipated absolute risk of major bleeding with aspirin exceeds absolute MI benefits for every level of ASCVD risk.

Discussion

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Cite This Study

Khan et al. (2023) conducted a meta-analysis in Without atherosclerotic cardiovascular disease (ASCVD) (n=171,215). Aspirin vs. Placebo or no aspirin was evaluated on Myocardial infarction (fatal and nonfatal) (RR 0.85, 95% CI 0.77-0.95, p=<0.001). In adults without ASCVD, aspirin reduced myocardial infarction (RR 0.85) but increased major bleeding (RR 1.48), and concomitant statin therapy diminished the absolute risk reduction for MI.

synapsesocial.com/papers/6a1c13c7d54006be995f82f7 https://doi.org/10.1016/j.jacadv.2022.100197

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