Miriam E Tucker

September 14, 2016

MUNICH — Aspirin has been overused more often than it has been underused as primary prevention for cardiovascular disease in patients with diabetes, new research suggests.

The electronic health record data from a large primary-care setting also reveal that underuse of aspirin for primary prevention has been more of a problem than overuse in people with reversible cardiovascular risk factors who don't have diabetes and that implementation of an electronic decision support tool may help improve adherence to guidelines in general for aspirin prescribing.

The findings were presented September 13, 2016 here at the European Association for the Study of Diabetes (EASD) 2016 Annual Meeting by A Lauren Crain, PhD, a researcher and statistician at Health Partners Institute, Minneapolis, MN.

"Clinical information needed to accurately assess the relative benefits and potential harms of aspirin are rather lengthy and might not be at one's fingertips in the context of a primary-care setting. [This situation] can serve as a barrier to providers in giving patients guideline-consistent recommendations and may potentially be associated with over- or underuse of aspirin," Dr Crain said during her presentation.

The randomized trial examined the impact of a decision-support tool on the appropriateness of aspirin prescribing for nearly 4000 people with diabetes and 7000 with reversible cardiovascular risk factors but no diabetes.

The findings of overuse in the diabetes patients and underuse in those with no diabetes but other risk factors were based on old US Preventive Services Task Force (USPSTF) guidelines, which advised aspirin use for primary CV prevention of coronary heart disease in men age 45 to 79 years and for stroke prevention in women aged 55 to 79 years, when the potential CVD benefit outweighs the potential harm of gastrointestinal hemorrhage.

In April 2016, the USPSTF revised those guidelines, advising that people aged 50 to 69 years who have a 10% or greater 10-year risk for cardiovascular disease (CVD) and who do not have higher risk for bleeding should consider taking low-dose aspirin to help prevent CVD (and colorectal cancer).

Problem of Overuse of Aspirin in Diabetes Should Lessen

Data on the effect of the new USPSTF guidelines on aspirin prescribing won't be available for some time, but the study's senior clinical investigator, Patrick J O'Connor, MD, from HealthPartners Institute, told Medscape Medical News, "I think the problem of overuse will become less and underuse will become more. The new guidelines are more inclusive and simpler, so the problem of underuse will be more prominent now....Doctors should be alert for people for whom it will be appropriate to use aspirin."

Asked to comment, session moderator Soffia Gudbjörnsdottir, MD, professor in diabetes and registry studies at the University of Gothenburg, Sweden, referenced the European guidelines. "The times are changing....Perhaps today you don't need a complicated algorithm....I think we have more evidence against overuse today."

She called the evidence previously used to support routine aspirin use in diabetes patients without established CVD "shaky," adding, "Only having diabetes and nothing else is not seen as requiring aspirin today."

And, she noted, "It's a clinical decision, but we need more and more decision tools. I'm happy that people are trying to do this and evaluate it. There are so many things to keep together. Still, overuse of aspirin is a much bigger problem than underuse."

Aspirin Misuse

In the study, 20 primary-care clinics were randomized to two groups — 10 to usual care, and 10 to the use of software called "Cardiovascular Wizard," developed at HealthPartners Institute. The tool automatically identifies people with CV risk and targets poorly controlled reversible risk factors such as hypertension, dyslipidemia, and/or tobacco use.

The tool provides real-time clinical decision support through the electronic health record during patient encounters and prioritizes clinical actions based on patient benefit. Specifically, the tool calculates 10-year atherosclerotic vascular disease (ASCVD) risk and potentially reversible risk percentage and generates individualized goals and priorities. It also promotes shared decision making, Dr Crain explained.

From among all patients seeking care during 2013–2014, there were 3958 patients with diabetes but no CVD and 7000 without diabetes but with high CV risk due to reversible factors.

At baseline, 71% of the diabetes patients were currently using aspirin. Of 1474 for whom aspirin was not indicated, 57% were using it, representing "overuse." Of 2484 in the diabetes group for whom aspirin was indicated, 79% were using it, a 21% underuse.

In the nondiabetic group with reversible risk factors, only 27% were using aspirin. Of 1659 in whom it was not indicated, 34% were using it (overuse). But only 25% of the 5341 for whom aspirin was indicated were using it, representing a 75% underuse rate.

Decision Support

After implementation of the decision-support tool in 10 of the clinics, total use of aspirin rose just slightly among the diabetes patients at all 20 clinics, with no significant differences seen in underuse or overuse with or without the software.

However, in the reversible-risk-factor group, the tool did appear to make a difference, with underuse dropping significantly among the 658 in whom it was indicated with the software (10% vs 13%).

The reason for the lack of effect of the tool in the diabetes group may relate to the interface used at the time, which may have caused confusion. It is currently being modified, Dr Crain noted.

However, she noted, "Doctors reported a fair amount of satisfaction, [and there were] high use rates."

Dr O'Connor told Medscape Medical News that HealthPartners is aiming to make the software — which is being developed for clinical decision-making support in several chronic conditions — available to other practices and providers soon.

At least initially, providers would be required to manually enter the tool's data into their own EHRs, share maintenance costs, and "make sure they agree with the recommendations in there…but of course, they're all evidence-based."

The study was funded by the National Heart, Lung, and Blood Institute. Neither the investigators nor Dr Gudbjörnsdottir have relevant financial relationships.

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European Association for the Study of Diabetes 2016 Meeting; September 13, 2016. Abstract 72.

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