A multi-center clinical trial, REACT-AF, is underway to determine if wearable technology can safely guide the use of anticoagulants in patients with atrial fibrillation (AFib). The study, which has Allegheny General Hospital (AGH) as one of its leading enrollment sites, is investigating whether an Apple Watch can effectively monitor irregular heart rhythms and inform decisions to temporarily discontinue blood thinners, potentially reducing bleeding complications without increasing stroke risk.
The REACT-AF trial, launched in July 2023, is a randomized, blinded endpoint study aiming to enroll 5,350 participants across roughly 100 sites in the United States. Participants are randomized into two groups: a control group that continues their prescribed anticoagulant regimen and an experimental group that uses an Apple Watch to continuously monitor for AFib. The smartwatch, paired with the patient's iPhone, tracks heart rhythms every 15 minutes. If a patient in the experimental group experiences 30 consecutive days without an AFib episode lasting longer than one hour, they may discontinue their anticoagulant medication under clinical supervision.
The primary goal of REACT-AF is to assess whether this technology-driven, intermittent approach to anticoagulation is non-inferior to continuous anticoagulation in preventing stroke and systemic embolism in patients with AFib. Secondary endpoints include evaluating the incidence of bleeding events and assessing patient quality of life.
Personalizing Anticoagulation Therapy
Atrial fibrillation, characterized by irregular and often rapid heart rhythms originating in the upper chambers of the heart, affects millions of people worldwide. AFib increases the risk of stroke due to the potential for blood clot formation. While anticoagulants are effective in reducing this risk, they also carry an increased risk of bleeding.
"Although taking blood thinners daily is known to lower stroke risk in Afib patients, they are also associated with an increase in bleeding complications. The purpose of this trial is to better understand how to personalize anticoagulation safely and effectively, especially for patients with isolated atrial fibrillation episodes," said Amit Thosani, MD, principal investigator of the trial at AGH and Director of the Mario Lemieux Center for Heart Rhythm Disorders at AHN.
Study Design and Eligibility
Eligible patients for the REACT-AF trial must be between 22 and 85 years old, have a documented history of AFib, own an iPhone, and be at low to moderate risk for stroke. The trial participation lasts up to five years.
The use of wearable technology represents a significant advancement in cardiovascular medicine, offering the potential to improve both clinical decision-making and patient engagement. "The use of smartwatches is an exciting advance in cardiovascular medicine – not only do they help clinicians make more informed decisions for therapeutic approaches, but they also give patients more agency to take control of their life and in turn, improve their overall health and well-being," said Stephen Bailey, MD, cardiothoracic surgeon and Chair of AHN Cardiovascular Institute.
The Mario Lemieux Center for Heart Rhythm Care at AHN, supported by a $5 million commitment from the Mario Lemieux Foundation and Highmark Health, is actively involved in advancing research and innovation in cardiac electrophysiology, including AI solutions, clinical trials, and provider education. REACT-AF is one of 13 active clinical trials currently taking place at the Center.
