IMPACT-AFib: Drug initiation strategy in AF fails, but trial design sparks interest
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An early intervention to prompt patients with atrial fibrillation to initiate an oral anticoagulation prescription was no more effective than a delayed reminder to see a doctor, researchers reported.
Approximately 1 in 10 patients with AF and risk for stroke within 1 year initiated guideline-recommended oral anticoagulation following the receipt of an educational brochure on their disease, a similar rate to the control group, according to findings from the IMPACT-AFib trial presented at the virtual European Society of Cardiology Congress.
IMPACT-AFib was the first analysis completed using the novel FDA Catalyst network, which utilizes data from the public/private Sentinel network to identify and enroll patients and obtain outcomes for randomized trials.
“The FDA has developed the Sentinel network, which is a phase 4 safety monitoring network for medical products,” Sean Pokorney, MD, MBA, assistant professor of medicine at Duke University School of Medicine and member in the Duke Clinical Research Institute, said during the presentation. “The FDA sends out queries to the insurance companies or data partners. The insurance companies or data partners then analyze those queries, behind their firewalls and their own set of data, and they send back an aggregate data set. Those aggregate data sets can then be combined across multiple data partners to answer questions quickly and efficiently. More recently, the FDA and investigators have become interested in the ability to do randomized trials within this distributed data network.”
“Our workgroup’s approach was ambitious — be the first to combine well-curated electronic data from multiple national health plans to conduct a large pragmatic randomized trial,” Richard Platt, MD, MSc, professor and chair of the department of population medicine executive director of the Harvard Pilgrim Health Care Institute and an investigator for IMPACT-AFib, said in a press release. “It had never been done before, but a novel method is required when trying to tackle a critical public health issue.”
For the trial, investigators enrolled U.S. patients aged 30 years or older with two claims for AF, a CHA2DS2-VASc score of at least 2, no admission for bleeding in the past 6 months and no prescriptions for anticoagulants in the past year. One group of 23,546 patients was assigned to receive an early intervention, which included a one-time educational mailer aimed to reduce risk for bleeding, falls and stroke. Another group of 23,787 patients assigned to a delayed intervention, where at 12 months, notifications were sent to physicians and a patient/physician level intervention could be initiated.
Delayed vs. early intervention
The primary outcome was oral anticoagulation initiation at 1 year. The secondary outcomes were number of days on oral anticoagulation, number of patients on anticoagulation at 12 months, all-cause mortality and admissions for bleeding or stroke.
Over the course of the trial, patients filled at least one oral anticoagulant prescription at the following rates at the following time points:
- at 42 days, the point at which there was the greatest difference between the groups, 1.67% for early group vs. 1.52% for delayed group (adjusted OR = 1.09; 95% CI, 0.94-1.26);
- at 90 days, 3.27% for early group vs. 3.1% for delayed group (aOR = 1.05; 95% CI, 0.95-1.16);
- at 183 days, 5.95% for early group vs. 5.73% for delayed group (aOR = 1.04; 95% CI, 0.96-1.12); and
- at 1 year, 9.89% for early group vs. 9.8% for delayed group (aOR = 1.01; 95% CI, 0.95-1.07).
“There were not statistically significant differences between the two groups across a variety of time points,” Pokorney said during the presentation. “However, the early intervention cohort did have numerically more patients initiate anticoagulation early after the mailing was sent out and this finding was attenuated over time.”
Investigators observed no between groups differences for any of the secondary outcomes.
“The evidence generated from the trial showed that a single educational mailing about the recommended treatment, as compared to a control group, wasn’t effective in this context,” investigator Christopher Granger, MD, professor of medicine and professor in the school of nursing at Duke and member in the Duke Clinical Research Institute, said in the release. “And while the intervention did not increase the proportion of patients with at least one OAC dispensed, the study itself is a tremendous success. We conducted an extensive collaboration to conduct the first-ever trial using a decentralized database of claims data — that, in and of itself, sets a foundation for future clinical trials in AF and other diseases.”
Education ‘more efficient’ with repeated process
In a discussion after the presentation, Christophe Leclercq, MD, PhD, FESC, FEHRA, of the department of cardiology and vascular disease at Centre Cardio-Pneumologique in Rennes, France, said, “I think that we can conclude that one single mailer to patients without interaction or repetition has no benefit when you follow-up for the use of oral anticoagulants. Personally, I found that the document mailed to the patient was more focused on complications or on the risk of falls than the benefits of anticoagulation.
“Education seems more efficient with a repeated process, with a multidisciplinary approach as illustrated in the RACE IV trial, which showed that when you make education with nurses, you significantly increase the use of anticoagulants,” Leclercq said. “Finally, it was a very strong, positive point in this study. It was a completion of the study using the real-world evidence with the Catalyst network, from the FDA, showing the transition from randomized controlled trial to real-world evidence.”
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Pokorney S. Hot Line: IMPACT-AFib. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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