The benefits of aspirin use in preventing serious vascular events in diabetic patients were largely counterbalanced by major bleeding events, said investigators presenting findings on Aug. 26 from the ASCEND trial as part of ESC Congress 2018. Additionally, a separate ASCEND study also presented Aug. 26 found fish oil supplements did not reduce the risk of cardiovascular events or stroke in this patient group.

In the ASCEND aspirin study, simultaneously published in the New England Journal of Medicine (NEJM), researchers randomly assigned 15,480 patients with diabetes but no history of cardiovascular disease to aspirin (100 mg daily) or placebo. During an average 7.4 years of follow up, they assessed the primary efficacy endpoint of first serious vascular event (non-fatal heart attack, non-fatal stroke, or death from cardiovascular cause) as well as the primary safety endpoint of first major bleed serious enough to require hospitalization or be fatal.

Overall findings showed a first serious vascular event occurred in 685 participants (8.5 percent) in the aspirin group compared with 743 in the placebo group (9.6 percent). According to researchers, this translated to 11 of every 1,000 participants avoiding a serious vascular event during the trial as a result of aspirin, as well as a 12 percent proportional reduction in the risk of serious vascular events. However, a first major bleed occurred in 314 of those in the aspirin group (4.1 percent) compared with 245 of those in the placebo group (3.2 percent); meaning nine of every 1,000 participants suffered a first major bleed during the trial due to aspirin. These findings were consistent even among participants at the highest cardiovascular risks. Researchers noted it was not possible to identify a group of patients in whom the benefits of aspirin use clearly outweighed the risks.

Professor Jane Armitage, principal investigator, Nuffield Department of Population Health, University of Oxford, UK, said: "Even though we showed clearly that aspirin reduces the risk of vascular events, including heart attacks, strokes, and mini-strokes, it also increased the risk of major bleeds, mainly from the gastrointestinal tract, so overall there was no clear benefit. It had been suggested that low-dose aspirin might protect against cancer, but we saw no reduction in any cancers; we are continuing to follow the participants to see whether any benefits appear later."

Meanwhile, the separate ASCEND study, also simultaneously published in NEJM, addressing use of fish oil supplements in 15,480 diabetic patients found no significant differences in outcomes between those taking supplements and those taking a placebo. According to researchers, a first serious vascular event occurred in 689 participants (8.9 percent) allocated to fish oil supplements and 712 participants (9.2 percent) allocated placebo over an average follow-up period of 7.4 years.

"This is a disappointing finding, but it is in line with previous randomized trials in other types of patient at increased risk of cardiovascular events which also showed no benefit of fish oil supplements," said Louise Bowman, MD, also from the Nuffield Department of Population Health at the University of Oxford. "Our large, long-term randomised trial shows that fish oil supplements do not reduce the risk of cardiovascular events in patients with diabetes. There is no justification for recommending fish oil supplements to protect against cardiovascular events."

Keywords: ESC18, ESC Congress, Aspirin, Primary Prevention, Cardiovascular System, Platelet Aggregation Inhibitors, Angina, Stable, Acute Coronary Syndrome, Fish Oils, Fatty Acids, Omega-3, Dietary Fats, Unsaturated, Diabetes Mellitus

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