December 21, 2018
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Preventive aspirin use may cause major bleeding in patients without CVD history

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Anthony A. Bavry
Anthony A. Bavry

The daily use of aspirin to prevent CV events in patients lacking a history of CVD is linked to an increased likeliness of major bleeding, according to a meta-analysis published in the European Heart Journal.

Researchers sought to perform an updated meta-analysis of randomized trials to examine the effectiveness of aspirin use among patients without previous atherosclerotic CVD.

“The use of aspirin for primary prevention of cardiovascular events in patients without prior history of atherosclerotic cardiovascular disease is a heavily debated topic, with a few guidelines recommending against its use and others endorsing it in high-risk patients such as those with high cardiovascular risk or diabetics,” Anthony A. Bavry, MD, MPH, associate professor of medicine at the division of cardiovascular medicine at the University of Florida and a Cardiology Today’s Intervention Editorial Board Member, and colleagues wrote.

The researchers analyzed randomized trials comparing aspirin with placebo or no aspirin control. The primary outcome was all-cause mortality.

The study consisted of 157,248 participants (mean age, 61 years; 52% women; 14% smokers) from 11 trials, including the recent ASCEND, ARRIVE and ASPREE studies, with a weighted mean follow-up of 6.6 years.

According to the researchers, there was no difference in mortality between the aspirin and control groups (HR = 0.98; 95% CI, 0.93-1.04). Excluding non-placebo-controlled trials (RR = 0.99; 95% CI, 0.93-1.05) and two trials with a minority of patients with known CVD (RR = 0.99; 95% CI, 0.94-1.04) did not change the results.

The researchers identified that the incidence of major bleeding was higher with aspirin (RR = 1.47; 95% CI, 1.31-1.65), with results not changing after excluding the non-placebo trials (RR = 1.44; 95% CI, 1.28-1.62) and the trials with a minor percentage of patients with CVD history (RR = 1.44; 95% CI, 1.27-1.63).

Researchers also identified that aspirin was associated with increased risk for intracranial hemorrhage (RR = 1.33; 95% CI, 1.13-1.58).

The analysis also showed aspirin conferred reduced risk for MI (RR = 0.82; 95% CI, 0.71-0.94), but for that finding, there was great heterogeneity among studies (I2 = 67%).

According to Bavry and colleagues, the results of the meta-analysis showed a lack of benefit regarding all-cause mortality among patients with diabetes and those who have high CV risk, and is in line with the European Society of Cardiology recommendation against aspirin use in patients with diabetes without prior CVD history.

The use of aspirin among healthy individuals without atherosclerosis appears to be associated with increased harm and lack of mortality benefit, researchers wrote.

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“In this setting, aspirin is possibly associated with a modest reduction in MI risk; however, this comes at a cost of increased major bleeding and including intracranial hemorrhage,” Bavry and colleagues wrote. “The routine use of aspirin for primary prevention needs to be reconsidered.” – by Earl Holland Jr.

Disclosures: Bavry reports he received honoraria from the American College of Cardiology and Edwards Lifesciences. The other authors report no relevant financial disclosures.