The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said.

The Amplatzer Amulet device already has a nod in the EU, having gained the CE mark in 2013, and is available in Europe and certain other countries. A company spokesperson confirmed to BioWorld that there has been strong physician reception to the device in those markets.

Reducing the risk of ischemic stroke

Of note, the Amplatzer Amulet device could help those under consideration for treatment with blood thinners – such as warfarin and NOACs, the latter of which are now first-line therapies – to reduce the risk of ischemic stroke. These common strokes can affect those with AF; while NOACs may prove beneficial, there are several challenges associated with their use, such as the risk of bleeding events. These therapies also may prove expensive, provide a narrow therapeutic window and be associated with compliance issues on the part of the patient.

To that end, the CATALYST trial will randomize up to 2,650 subjects at 150 sites globally, with an eye toward assessing whether sealing off the LAA with this device may serve as an alternative to using these newer blood thinners over a patient’s lifetime.

"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 Vivek Reddy, director of cardiac arrhythmia services for The Mount Sinai Hospital in New York and the principal investigator for the CATALYST trial. "This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with [AF] who are at an increased risk for ischemic stroke."

The company spokesperson said Abbott expects to begin enrollment in coming months.

It is estimated that in U.S., AF prevalence is projected to rise from 5.2 million in 2010 to 12.1 million cases in 2030. “With our Amplatzer Amulet device, we hope to provide physicians with an alternative option for their patients with AF and potentially eliminate the need for blood thinners long-term,” the spokesperson said.

Other trials

This isn’t the only study in which the Amplatzer Amulet is being assessed. For example, the device also is being evaluated to show that its performance is non-inferior to the commercially available Watchman LAA closure device, from Boston Scientific Corp., in patients with non-valvular atrial fibrillation.

Also, Abbott and Feops NV, of Ghent, Belgium, also are supporting a study known as the PREDICT-LAA trial. Led by Copenhagen’s Righshospitalet, the study aims to determine if use of Feops Heartguide computer simulations based on cardiac computerized tomography imaging improve procedural planning and outcomes of percutaneous LAA closure with the Amplatzter Amulet.

During Abbott’s fourth-quarter earnings call in January, Barclays’ Kristen Stewart asked about estimates for launch of the Amulet.

Robert Ford, Abbott’s president, COO and director, replied that the company is a couple of years away. “So, we're still in ... clinical evaluation of that. We'll then ... put the information together to submit to the FDA.”

Sensyne Health

There are others looking into the benefits of drug therapy for these patients. On Jan. 21, artificial intelligence-focused Sensyne Health plc, of Oxford, U.K., reported that it had examined anonymized, routinely collected data from nearly half a million U.K. National Health Service patients as part of a study assessing whether there are benefits to the use of blood-thinning agents for all heart failure patients.

That company looked at warfarin, an off-patent drug developed in the 1940s, and NOACs, comparing the anonymized data over three years of heart failure patients with no record of anti-coagulant prescription with that of patients prescribed either warfarin or NOACs.

The data in this study suggested a small, but statistically significant survival benefit for heart failure patients without an irregular heartbeat on anticoagulants. However, additional analysis is needed to confirm if the difference is clinically relevant, and if so, which subgroups of patients would benefit. The analysis also suggested that there may be relevant differences, not only between the use of warfarin vs. NOACs, but also between the NOACs currently in use.

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