Baby aspirin equivalent to all doses to prevent repeated cardiac events

According to the ADAPTABLE trial, 81 mg daily dose of aspirin is less effective than 325 mg in secondary cardiovascular prophylaxis, but its legacy is primarily the first large-scale, practical heart disease based in the United States. It may be an exam.

The combined incidence of death from all causes and hospitalization for MI or stroke was similar at 7.28% at low doses and 7.51% at high doses (HR 1.02, 95% CI 0.91-1.14). Results were similar between subgroups of patients reported by Schuyler Jones, MD and his colleagues at the Duke Clinical Institute in Durham, North Carolina.

Hospitalization for major bleeding from blood product transfusions, the primary safety endpoint, occurred in 0.63% and 0.60% of patients, respectively (53 vs. 44 patients, HR 1.18, 95% CI 0.79-1.77).

Jones concluded that patients who are doing well at the current dose should be able to stay there and have no obligation to switch. American Heart Association (ACC) Virtual conference.The data was published at the same time New England Journal of Medicine..

However, for patients who start or resume aspirin, the 81 mg dose is “probably correct because it is well tolerated,” Jones said. Because there was no conclusive evidence that higher doses were better.

Almost 42% of the 325 mg randomized group switched to lower doses, often at the recommendation of their physician, while 7.1% moved from 81 mg to higher doses under an open-blind design.

Jones suggested that the clinician’s general beliefs and views about the highest dose are likely to be working. Primary prevention guidelines With that downgrade aspirin Double antiplatelet therapy guidelines He said it recommended that both doses of 81 mg come out during the course of the study. “So I think it made it more challenging.”

However, it happens frequently in clinical practice, said Jane Linderbaum, APRN, and CNP, ACC press conference debater at the Mayo Clinic in Rochester, Minnesota.

“It’s a matter of sharing decisions with patients and their priority medical needs. It’s very clear about what they’re taking and why they’re taking it.” She said. “We all know that patients often change their doses and types of medications themselves without medical advice. It needs to be very conscious and practical in our practice. There is. “

However, the only pre-specified analysis to investigate the effects of dose switching favored higher doses. Considering the actual dose as a time-dependent covariate, patients taking 81 mg of aspirin were at higher risk of the primary endpoint than those taking 325 mg (HR 1.25, 95%). CI 1.10-1.43).

“If the patient tolerated 325 mg, there was at least a signal that it might be right to keep that dose, talk to the clinician, and keep that dose,” Jones said in a press conference.

However, Jones warned of a clear bias in switching, saying the group would dig deeper into the exploratory analysis.

Greater impact

“I hoped this trial would be a one-time answer. [what is the best] Aspirin dose. ” Dr. Erin Mikos of Baltimore’s Johns Hopkins Medical College and School of Public Health, who was not involved in the trial, said.

Due to crossover issues, this trial may have been conducted only moderately in that regard, but it was considered a major victory for the design of clinical trials.

“The most important legacy of this trial is that you did it,” said Dr. Daniel Lloyd Jones, MD, a session debater at Northwestern University in Chicago.

Mikos agreed. “Despite the really important and neutral results of this exam, why am I still really excited about this … what was achieved in the exam design,” she said. “At least in the United States, it was very unique for a cardiovascular outcome test of this size. I think we are ready for how to design future cardiovascular tests.”

For a practical open-label trial, PCORnet-Participating centers through electronic health records as having established atherosclerotic cardiovascular disease and at least one risk factor. They were contacted, registered, and tracked for a median of 16.2 months, but did not have a dedicated office visit for the exam, all through electronic means.

Colin Bygent, MD, MD, Population and Health Research Unit, Medical Research Council, Oxford University, UK, said he used a series of innovative, low-cost methods to do this. NEJM editorial..

“”[F]Alternatively, for example, an algorithm was used to investigate electronic health record data to identify eligible patients within the National Patient-Centered Clinical Research Network (PCORnet). Patients can access the web portal to give informed consent and be notified about the aspirin regimen (simply purchased by themselves). And all test visits were made virtually or by phone, and the results were confirmed remotely and without arbitrage, “he wrote.

Similar large-scale, practical tests are being conducted in other countries. Ascend With the UK taste In Scandinavia, Vigent pointed out.

Michos said other practical trials are already underway in the United States, including 20,000 patients. Preventable trial.

Baigent responded to a pilot study on how to prevent adherence problems in future trials, revealing patient preferences for a dose of 81 mg, redesigning, and considering randomization for adherence patients.

“But ADAPTABLE shows a way to conduct tests efficiently and at low cost in the United States, and it’s a big achievement as it has become more widely adapted and available,” he concludes. .. “This should allow us to answer more clinical questions and provide obvious benefits to healthcare consumers.”