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:



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.

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

Feature | Cardiac Diagnostics | By Robert L. Quigley, MD, DPhil

Atherosclerotic cardiovascular disease (ASCVD), caused by plaque buildup in arterial walls, is one of the leading causes ...

Home January 23, 2024
News | Cardiac Diagnostics

September 5, 2023 — GE HealthCare announced the launch of a handheld, wireless ultrasound imaging system designed for ...

Home September 05, 2023
Feature | Cardiac Diagnostics | By Kelly Patrick

The global ambulatory diagnostic cardiology market was valued at $2.6 billion in 2022 and is forecast to rise to $3.3 ...

Home May 15, 2023
News | Cardiac Diagnostics

February 8, 2023 — Results of research that identified new causes of Atherosclerotic Coronary Artery Disease, or ASCAD ...

Home February 08, 2023
News | Cardiac Diagnostics

September 15, 2022 - Happitech has announced the launch of its FastStart Research app. The Amsterdam-based digital ...

Home September 15, 2022
Feature | Cardiac Diagnostics | by Kelly Patrick

Like most healthcare markets, the diagnostic cardiology market has had a bumpy ride in recent years. The COVID-19 ...

Home August 23, 2022
Feature | Cardiac Diagnostics | By Adam Saltman, MD, PhD

Before opining on the future of cardiac health, I think it’s important to define what “cardiac health” actually is. If ...

Home May 04, 2022
News | Cardiac Diagnostics

January 31, 2022 — Scientists have developed an artificial intelligence (AI) system that can analyze eye scans taken ...

Home January 31, 2022
News | Cardiac Diagnostics

November 10, 2021 — Abbott released new global market research from its Beyond Intervention initiative, the company’s ...

Home November 10, 2021
Feature | Cardiac Diagnostics | By Dave Fornell, DAIC Editor

October 29, 2021 — A new guideline for the evaluation and diagnosis of chest pain was released this week that provides ...

Home October 29, 2021
Subscribe Now