According to an innovative large-scale clinical trial reported recently in the New England Journal of Medicine, a single daily baby aspirin (81 mg) or a single daily adult aspirin (325 mg) are equally safe and effective for prevention of adverse cardiovascular events for patients with established atherosclerotic cardiovascular disease.
Among the 40 medical centers that participated in the trial, Vanderbilt University Medical Center was the largest recruiter, signing up 2,288 participants with cardiovascular disease, out of the national total of 15,076 trial participants.
At last count, 29 million Americans were taking a daily aspirin to prevent cardiovascular disease. With medical societies in the U.S. yet to publish dosage recommendations, some clinicians prescribe a baby aspirin for this indication and others prescribe a regular adult aspirin, or something in between.
While daily aspirin for certain patients has proven benefits, it also poses a risk of severe internal bleeding. Participants were followed for a median of 26 months. In all, 97 participants, or 0.6%,
experienced hospitalization for major bleeding, the trial’s primary safety outcome.
This is the first clinical trial to use the National Patient-Centered Clinical Research Network, or PCORnet. In 2010, Congress launched the Patient-Centered Outcomes Research Institute (PCORI), which in turn launched PCORnet in 2014 to support comparative clinical effectiveness research.
“Beyond addressing this important issue for patients with cardiovascular disease, this was an opportunity to demonstrate the usefulness of PCORnet for truly large-scale pragmatic trials,” said Russell Rothman, MD, MPP, director of the Vanderbilt Institute for Medicine and Public Health and Senior Vice President for Population and Public Health at VUMC.
Rothman is the principal investigator for the Stakeholders, Technology and Research Clinical Research Network, or STAR CRN, one of PCORnet’s founding partners. He co-chaired the executive steering committee for Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) and is among the report’s senior authors.
“Conventional clinical trials are very expensive to conduct. These trials can help to demonstrate treatment efficacy under optimal conditions, but may not always translate to what happens in real-world settings,” Rothman said. “At a fraction of the cost, pragmatic trials can help determine what commonly works best for patients in the real world.”
- There were no in-person visits: periodic participant assessment was by internet or telephone.
- Prospective participants were identified through queries of electronic health records (EHRs).
- Would-be participants used the ADAPTABLE patient portal to confirm eligibility and provide electronic consent.
- Having been randomized 1:1 to an 81 mg or 325 mg daily dosage, participants purchased their own aspirin (they received $25 to participate).
- EHR data helped fuel baseline patient assessments.
- Outcomes data were gathered from participant reports, EHR data and public and private health care payer data.
“At STAR CRN and across PCORnet, we’re bringing new flexibility, efficiency and power to clinical trials and effectiveness research, and this study provides an initial large-scale demonstration of that,” Rothman said.
Other study co-authors from VUMC include Sunil Kripalani, MD, MSc, Daniel Muñoz, MD, MPA, and David Crenshaw, LMSW.
