Northwestern University and Johns Hopkins University received a multimillion-dollar grant from the National Heart, Lung, and Blood Institute to study a “pill in the pocket” strategy to prevent stroke in patients with atrial fibrillation (AFib), the disorder of the most common heart rhythm in adults.
Currently, AFib patients are treated with continuous blood-thinning medications to reduce the risk of blood clots and stroke. This new trial funded by the National Institutes of Health will incorporate the use of an app on Apple Watch to monitor atrial fibrillation and try to reduce patients’ ongoing, lifelong reliance on blood-thinning medications.
The trial will incorporate the use of an app on Apple Watch to monitor atrial fibrillation in an attempt to reduce patients’ ongoing and lifelong reliance on blood-thinning medications.
The roughly $37 million award will fund the seven-year trial, called the Rhythm Evaluation for AntiCoagulaTion (REACT-AF) trial. NIH award funds for grant years two through seven are subject to successful completion of milestones during the first grant year.
The study is a collaboration between Northwestern University Feinberg School of Medicine and the American Heart Association. The study will use the innovative, scientifically validated heart health features in Apple Watch, through a contribution from Apple. Apple will also provide guidance on studio app development.
Using the app on Apple Watch and a companion app on iPhone, patients in the trial will be able to focus on the use of anticoagulant medications for a limited period of time and only in response to a prolonged AFib episode, thereby creating unique personalized care for each patient
If proven effective, this new treatment paradigm will fundamentally change the standard of care for the millions of Americans living with AFib.”
Principal Investigator, Director of the Center for Arrhythmia Research, Northwestern University
“If shown to be effective, this new treatment paradigm will fundamentally change the standard of care for the millions of Americans living with AFib,” said the lead researcher. Dr Rod Passmandirector of the Arrhythmia Research Center and professor of medicine in Feinberg’s division of cardiology.
“Many of these patients are on blood thinners for the rest of their lives, even if they have infrequent episodes of atrial fibrillation,” Passman said. “If we can show that this strategy is equally protective against stroke and reduces bleeding, that could save lives, reduce costs and improve quality of life.”
For eight years, Passman has been studying solutions to end the “one size fits all” standard practice of prescribing anticoagulants (blood thinners) for life to everyone with atrial fibrillation.
The trial secures Northwestern as a world leader in portable devices for the treatment of atrial fibrillation.
2.5 to 5 million
AFib is the most common heart rhythm disorder in adults, affecting 2.5 to 5 million Americans
While an estimated 2.5 to 5 million Americans are living with AFib today, that number is estimated to increase to 12.1 million by 2030. Worldwide, the estimated number of people with AFib in 2010 was 33.5 million, according to a 2013 study.
Determine when to use blood thinners to limit dependency
AFib is a heart rhythm disorder characterized by rapid and irregular heartbeats from the upper chambers of the heart. People with AFib are at increased risk of stroke, so many receive ongoing treatment with blood-thinning medications to reduce that risk. But this treatment also increases the risk of bleeding, according to Passman, and balancing risks and benefits can be challenging for both patients and doctors.
However, some patients with AFib have infrequent episodes of irregular heartbeat, either on their own or as a result of medications or procedures. Current evidence suggests that the risk of stroke increases in the weeks following an episode of atrial fibrillation and then returns to baseline, raising the possibility of intermittent anticoagulation therapy.
Since many people don’t have symptoms during an AFib episode, the new trial will use Apple Watch to monitor heart activity and notify patients when they’re entering an episode.
When notified, patients will take blood-thinning medications for a few weeks during the high-risk window for stroke and can stop if they don’t have another episode. This “pill in your pocket” approach could protect patients against stroke while reducing bleeding events and the cost of Afib treatment, Passman said.
“We believe that advances in technology will allow us to personalize this care,” Passman said. “Why should patients be exposed to the risk and cost of these drugs when they may not be benefiting?”
More about the trial:
The seven-year trial will enroll 5,400 patients, randomizing them to receive either the current standard of care or treatment directed by the app on Apple Watch. The trial will also examine whether the app can reduce major bleeding events compared to continuous therapy.
Secondary objectives include measurement of patient satisfaction and utilization of health care resources. Importantly, the trial will reveal important information about AFib regardless of the findings, according to Passman.
Trial secures Northwestern as a world leader in wearable devices for the treatment of atrial fibrillation
“Although most data suggest that the atrial fibrillation rhythm itself causes the stroke, there is an alternative hypothesis that the risk remains even when the rhythm itself disappears,” Passman said. “If this strategy is not equally effective, then perhaps we should reconsider whether heart rhythm causes stroke or is simply a marker of some underlying mechanism.”
This grant application was administratively supported by the Northwestern University Institute for Clinical and Translational Sciences (NUCATS)the Bluhm Cardiovascular Institute Clinical Trials Unit and the Trial Innovation Network.
Northwestern is the main study site. Partner institutions include Johns Hopkins, Stanford University, and the University of California, San Francisco.
