Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it frictionless and removing the need for mechanical bearings.
Study investigators recruited a total of 1,028 patients with severe heart failure for its MOMENTUM-3 trial at 69 U.S. centers. Patients in the trial either needed an LVAD as a bridge to a heart transplant or relied on the LVAD as a lifelong therapy, Abbott said.
Patients in the trial were randomized to receive either the HeartMate 3 or a HeartMate II system, and all received blood-thinning medications following surgery and were taking between 81 to 325 mg of Aspirin daily, the company said.
Data presented came from two pre-specified interim analysis and a final analysis at two-years post enrollment, Abbott said.
At two years, 74.7% of HeartMate 3 patients met the primary endpoint of the trial, compared with only 60.6% of patients with the HeartMate II. Pump replacement rates at two years was 2.3% for HeartMate 3 patients versus 11.3% for patients with a HeartMate II.
Rates of pump clotting were significantly lower for HeartMate 3 patients at 1.4% versus 13.9% for patients with HeartMate II devices. Rates of disabling stroke were closer between groups, at 5% for HeartMate 3 patients versus 7.5% for HeartMate II patients.
Rates of bleeding and gastrointestinal bleeding were reported at 43.7% and 24.5% respectively for HeartMate III patients, higher than the 55% and 30.9% reported for Heartmate II patients.
Patients treated with the HeartMate 3 spent on average 48 more days on LVAD support outside of a hospital than their Heartmate II counterparts and fewer days in the hospital after readmission, at 13 days versus 18 days, respectively.
Researchers noted an increased risk of infections at two years, and commented that they were working with infection disease experts to explore new ways to reduce infection susceptibility.
Study investigators said they plan to follow patients in the trial out to three years, and that they are looking to develop a new trial to explore how to optimize medical therapy for advanced heart failure patients.
“These final results from what is by far the largest LVAD trial ever conducted demonstrate the clinical superiority of the HeartMate 3 compared with its predecessor, the HeartMate II. We have shown a decrease in adverse events that uniquely occur due to the interface between the patient and the mechanical pump. These include a consistent and reliable reduction in strokes of all kinds and severity with the HeartMate 3 but also a remarkable reduction in the rate of pump-related blood clots and significant reductions in all types of bleeding, especially gastrointestinal bleeding. In addition to having significantly lower rates of adverse events, patients who received the HeartMate 3 had a lower rate of readmission to the hospital and spent fewer days in the hospital when they were readmitted,” lead author Dr. Mandeep Mehra of Brigham and Women’s Hospital said in a press release.
Mehra added that based on the results, he believes that the HeartMate 3 should be considered the standard of care for patients with advanced heart failure who do not respond to guideline-directed medical therapy.
