In the Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) trial, researchers compared treatment with warfarin to a fabric-covered, expandable cage called the WATCHMAN. The device blocks blood clots that typically form in the heart's left atrial appendage. The 707 patients were randomly assigned to one of the two treatments.
"Efficacy was dramatically better with the device, and stopping the warfarin," Holmes said.
The researchers found that patients with the WATCHMAN had a 32 percent lower risk of stroke and cardiovascular death compared with warfarin therapy. This was especially true for hemorrhagic stroke, which causes bleeding in the brain and is usually fatal, Holmes noted.
In addition, there were fewer complications with the device, once it was implanted, compared to warfarin. Most complications with the device occurred when placing it in the heart, but these complications now occur in only 1 percent of patients, Holmes noted.
The researchers concluded that the device is an effective alternative to warfarin for preventing stroke in patients with atrial fibrillation, particularly those at the highest risk of stroke.
"A strategy like this can be used in patients with non-valvular atrial fibrillation to prevent stroke, and get them off warfarin," Holmes said.
Dr. Gregg C. Fonarow, professor of cardiology at the University of California, Los Angeles, thinks this device will benefit many patients with atrial fibrillation.
"The major risk of atrial fibrillation is blood clots forming in the heart, and then breaking loose to cause stroke. Most of these blood clots form in the appendage of the left atrium," Fonarow said.
The only effective treatment until now was lifelong use of warfarin. Researchers have been searching for alternative therapies to warfarin t
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