If a small dose of aspirin can help prevent a second heart attack or stroke in people with heart disease, will a larger dose work even better? According to results of the ADAPTABLE aspirin study presented at the 70th annual American College of Cardiology Scientific Session and published in the May 15 New England Journal of Medicine, the answer is ‘no.’
Among 15,076 people with heart disease who took either 81 mg. or 325 mg. of aspirin daily to prevent another heart attack or stroke or death, the researchers found no significant differences between the two groups in the rates of subsequent heart attacks, strokes, death or major bleeding, a common side effect of aspirin. The ADAPTABLE study was designed to determine the safest and most effective dose of aspirin for patients with existing cardiovascular disease.
One of the most interesting aspects of the landmark study is that it was performed remotely—long before the COVID-19 pandemic hit. When the study began five years ago, research teams from 40 clinical centers nationwide—including the OneFlorida+ Clinical Research Network—identified 450,000 people from electronic health records in PCORnet and invited them to participate in the trial. After enrolling 15,076 people online, participants were randomized to take a daily dose of either 81 mg. of aspirin or 325 mg. Electronic patient follow-up for patient-reported outcomes was completed every three to six months. Patient-reported data was supplemented by searches of the electronic health records and claims data.
“We learned so many incredible things from ADAPTABLE about how to streamline processes and alleviate the burden of participating in research for both sites and patients,” said Schuyler Jones, MD, the principal investigator of the ADAPTABLE study at the Duke Clinical Research Institute at Duke University in Durham, North Carolina. “From its remote follow-up techniques to its engagement with patient partners, ADAPTABLE provides a blueprint for how research can be improved in the future.”
The ADAPTABLE writing team concluded that “As interest grows for real-world evidence, the trial provides a demonstration that randomized clinical trials can leverage electronic health record data, direct-to-patient methods, and patient-reported outcomes to address important, patient-centered questions. Future trials may take lessons learned from this one as fit for purpose, balancing trade-offs on precision versus generalizability as well as costs.”
OneFlorida+ faculty and staff who served on the writing team for ADAPTABLE included David Anderson, M.D., who served as UF Health site PI for ADAPTABLE, Carl J. Pepine, M.D., Eileen Handberg, Ph.D., Brittney Roth Manning, M.P.H., Elizabeth Shenkman. Ph.D., and Citizen Scientist Doris N. Zemon, R.N.