Continuous, long-term wearable heart monitors helped identify 52% more cases of atrial fibrillation compared with usual care, but that didn’t lead to a reduction in stroke hospitalizations, according to a study led by the Duke Clinical Research Institute.
The findings, published on September 1 at the meeting of the European Society of Cardiology and in the journal Journal of the American College of Cardiology, There is no conclusive data on whether screening for atrial fibrillation reduces stroke rates. The COVID pandemic led to an early stop to the study before enrollment was complete, so there were not enough participants to establish definitive results on stroke.
“Atrial fibrillation often goes undiagnosed and may increase the risk of ischemic stroke, which is largely reversible with oral anticoagulation,” said senior author Renato Lopes, M.D., Ph.D., professor of medicine and member of the Duke Clinical Research Institute.
“We still need definitive evidence that diagnosing atrial fibrillation through systematic screening can lead to subsequent treatment with oral anticoagulation and, therefore, to a lower risk of stroke,” Lopes said.
The study included approximately 12,000 patients in the United States who were at least 70 years old and had no history of atrial fibrillation. About half of the patients were randomly assigned to receive a long-term (14-day) continuous monitoring device and half to receive usual care.
During a median follow-up of 15 months, the study reported a 52% increase in the number of atrial fibrillation cases diagnosed among device users compared with those receiving usual care. There was no increase in hospitalization rates for bleeding and no significant reduction in the rate of hospitalizations for all strokes compared with usual care.
The study was originally designed to include 52,000 patients, which would have given it the power to determine whether screening reduces the number of strokes. A large study population is needed because strokes occur in a subgroup of patients with atrial fibrillation.
“Despite the inconclusive results, we have learned many lessons that could serve as a basis for future studies,” Lopes said. He added that the study design, which allowed patients to enroll and be examined online in a virtual format with self-applied patch devices in their homes with only remote assistance, could be duplicated in future studies.
In addition to Lopes, study authors include Steven J. Atlas, Alan S. Go, Steven A. Lubitz, David D. McManus, Rowena J. Dolor, Ranee Chatterjee, Michael B. Rothberg, David R. Rushlow, Lori A. . Crosson, Ronald S. Aronson, Michael Patlakh, Dianne Gallup, Donna J. Mills, Emily C. O’Brien, and Daniel E. Singer.
The study received financial support from the Bristol-Myers Squibb/Pfizer Alliance.