News | Pharmaceuticals | September 04, 2018

Effect of Daily Aspirin on First-Time Heart Attack and Stroke Risk Inconclusive

ARRIVE study finds daily aspirin does not reduce major cardiovascular event occurrence

Effect of Daily Aspirin on First-Time Heart Attack and Stroke Risk Inconclusive

September 4, 2018 — The jury is still out on whether people at moderate risk of a first heart attack or stroke should take daily aspirin to lower their risk, according to late-breaking results from the ARRIVE study. Results from ARRIVE (Aspirin to Reduce Risk of Initial Vascular Events) were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2018, Aug. 25-28 in Munich, Germany, with simultaneous publication in The Lancet.1

Prof. J. Michael Gaziano, M.D., MPH, principal investigator, of the Brigham and Women's Hospital, Boston, said, “Aspirin did not reduce the occurrence of major cardiovascular events in this study. However, there were fewer events than expected, suggesting that this was, in fact, a low-risk population. This may have been because some participants were taking medications to lower blood pressure and lipids, which protected them from disease.”

The benefit of aspirin for preventing second events in patients with a previous heart attack or stroke is well established.2 Its use for preventing first events is controversial, with conflicting results in previous studies and recommendations for and against its use in international guidelines. Recommendations against its use cite the increased risk of major bleeding.2

The ARRIVE study assessed the impact of daily aspirin on heart attacks, strokes and bleeding in a population at moderate risk of a first cardiovascular event. Moderate risk was defined as a 20–30 percent risk of a cardiovascular event in 10 years. The study enrolled individuals with no prior history of a vascular event, such as stroke or heart attack. Men were at least 55 years old and had two to four cardiovascular risk factors, while women were at least 60 years old with three or more risk factors. Risk factors included smoking, elevated lipids and high blood pressure.

A total of 12,546 participants were enrolled from primary care settings in the U.K., Poland, Germany, Italy, Ireland, Spain and the U.S. Participants were randomly allocated to receive a 100 mg enteric-coated aspirin tablet daily or placebo. The median follow-up was 60 months. The primary endpoint was time to first occurrence of a composite of cardiovascular death, myocardial infarction, unstable angina, stroke and transient ischaemic attack.

The average age of participants was 63.9 years and 29.7 percent were female. In the intention-to-treat analysis, which examines events according to the allocated treatment, the primary endpoint occurred in 269 (4.29 percent) individuals in the aspirin group versus 281 (4.48 percent) in the placebo group (hazard ratio [HR] 0.96, 95 percent confidence interval [CI] 0.81–1.13, p=0.60). In the per-protocol analysis, which assesses events only in a compliant subset of the study population, the primary endpoint occurred in 129 (3.4 percent) participants of the aspirin group versus 164 (4.19 percent) in the placebo group (HR 0.81, 95 percent CI 0.64–1.02, p=0.0756).

In the per-protocol analysis, aspirin reduced the risk of total and nonfatal myocardial infarction (HR 0.53, 95 percent CI 0.36–0.79, p=0.0014; HR 0.55, 95 percent CI 0.36–0.84, p=0.0056, respectively). The relative risk reduction of myocardial infarction in the aspirin group was 82.1 percent, and 54.3 percent in the 50–59 and 59–69 age groups, respectively.

All safety analyses were conducted according to intention-to-treat. Gastrointestinal bleedings, which were mostly mild, occurred in 61 (0.97 percent) individuals in the aspirin group versus 29 (0.46 percent) in the placebo group (HR 2.11, 95 percent CI 1.36–3.28, p=0.0007). The overall incidence of adverse events was similar between treatment groups. Drug-related adverse events were more frequent in the aspirin (16.75 percent) compared to placebo (13.54 percent) group (p<0.0001), the most common being indigestion, nosebleeds, gastro-oesophageal reflux disease and upper abdominal pain.

Gaziano said, “Participants who took aspirin tended to have fewer heart attacks, particularly those aged 50–59 years, but there was no effect on stroke. As expected, rates of gastrointestinal bleeding and some other minor bleedings were higher in the aspirin group, but there was no difference in fatal bleeding events between groups.”

He concluded, “The decision on whether to use aspirin for protection against cardiovascular disease should be made in consultation with a doctor, considering all the potential risks and benefits.”

For more information: www.escardio.org

 

References

1. Gaziano J.M., Brotons C., Coppolecchia R., et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. The Lancet, Aug. 26, 2018.  http://dx.doi.org/10.1016/S0140-6736(18)31924-X

2. Piepoli M.F., Hoes A.W., Agewall S., et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2016;37:2315–2381.

Related Content

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a costly tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. Amyloidosis Patient Registry  #Amyloidosis

With the advent and optimization of nuclear scintigraphy protocols using bone-avid radiotracers, cardiac amyloidosis caused by transthyretin protein (ATTR) can now be diagnosed noninvasively without a tissue biopsy. The radiotracer 99mTc-pyrophosphate (99mTc-PYP) binds to deposited ATTR amyloid fibrils in the myocardium and can be visualized using planar and SPECT imaging. This is Figure 2, showing how SPECT imaging allows the reader to distinguish between blood pool activity (ventricular cavity, etc) and myocardial activity and identify regional myocardial differences in radiotracer uptake.

News | Cardiac Diagnostics | March 05, 2020
March 5, 2020 — More than 300 patients have joined the Amyloidosis Patient Registry and it is now available to the en
heart disease image
News | Cardiac Diagnostics | December 18, 2019
December 18, 2019 — In their latest report, “...
FDA Warns Troponin Tests Impacted by Biotin Dietary Supplement
Feature | Cardiac Diagnostics | November 05, 2019 | Dave Fornell, Editor
November 5, 2019 — The U.S.
Videos | Cardiac Diagnostics | October 29, 2019
Doctor Clyde Yancy was a keynote speaker and said doctors need to check their assumptions about patients at the door...
79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event

79-year-old Tony Marovic had a right carotid endarterectomy shortly after discovering a 95 percent blockage of his carotid artery at a health and wellness screening event. Image courtesy of University Hospitals.

News | Cardiac Diagnostics | October 16, 2019
Health and wellness screenings are more than just nice events for the community – they can save lives. A Mentor, Ohio,...
Pesticide Exposure May Increase Heart Disease and Stroke Risk

Image courtesy of zefe wu from Pixabay

News | Cardiac Diagnostics | October 15, 2019
On-the-job exposure to high levels of pesticides raised the risk of heart disease and stroke in a generally healthy...
World Heart Federation Launches Global Roadmap on Cardiovascular Disease Prevention Among Diabetics
News | Cardiac Diagnostics | September 04, 2019
At the European Society of Cardiology (ESC) Congress 2019 together with the World Congress of Cardiology, the World...
Insomnia Tied to Higher Risk of Heart Disease and Stroke

Image courtesy of the American Heart Association

News | Cardiac Diagnostics | August 19, 2019
People suffering from insomnia may have an increased risk of coronary artery disease, heart failure and stroke,...