Abbott plans to launch a head-to-head study that puts its structural heart device up against a newer generation of blood thinners, testing its ability to lower the risk of strokes in people with atrial fibrillation.
The devicemaker’s Amplatzer Amulet occluder is designed to permanently block a small, naturally forming pouch that develops within the muscle wall of the heart’s left atrium. In people with an irregular pulse, this appendage can fail to drain completely with each heartbeat; the blood that pools there can form clots that, once loose and pumped out of the heart, can cause debilitating or fatal strokes.
The randomized study, dubbed CATALYST, will evaluate the device’s performance over at least two years compared to blood thinners known as non-vitamin K antagonist oral anticoagulants, or NOACs, and as an alternative to the lifetime regimens that currently serve as a standard-of-care for patients with AFib.
This class of drugs includes blockbusters like Eliquis, Xarelto and Pradaxa, which are now recommended over warfarin in cardiology treatment guidelines.
"A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with atrial fibrillation eligible for long-term NOAC therapy," said the study’s principal investigator, Vivek Reddy, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital.
Starting next month, the study plans to enroll up to 2,650 participants at 150 global sites, measuring rates of ischemic strokes, embolisms or cardiovascular mortality, as well as major bleeding events. Delivered to the heart by a catheter, the Amplatzer Amulet previously received a CE mark in 2013.
"The CATALYST trial has the potential to provide data for the Amplatzer Amulet LAA Occluder that could change clinical practice by eliminating a lifetime need for blood thinners—reinforcing our mission of helping people live better lives through better health,” Neil Moat, chief medical officer of Abbott’s structural heart business, said in a statement.
Abbott estimates that the prevalence of atrial fibrillation will rise over the coming decade to at least 12.1 million cases, with strokes related to AFib being nearly twice as fatal compared to unrelated strokes.