Among patients with aortic regurgitation (AR) undergoing TAVR with the Trilogy valve, the rate of mortality at one year was 8.1%, significantly lower than the prespecified goal of 25% to show noninferiority, according to a study presented during a Late-Breaking Clinical Trial session at ACC.25 in Chicago.

The ALIGN-AR trial enrolled 500 patients between 2018 and 2024, with180 patients enrolled in a premarket approval cohort and 320 patients in a continued access cohort. All patients had moderate to severe symptomatic AR and underwent TAVR with the Trilogy valve, the first device designed specifically for transcatheter replacement of the aortic valve in patients with AR, using anchors to attach to the three leaflets of the aortic valve. To date, about 360 patients have at least one year of follow-up after their procedure and 200 have about two years of follow-up.

Results showed that survival at one year was 91.9%, exceeding the prespecified threshold of 75% survival or better to indicate the valve was noninferior. The study reported a device success rate of 96.4% and low rates of residual regurgitation, with only 1.5% of patients experiencing more than mild regurgitation at 30 days and valve embolization noted in only 1.6%. The 30-day mortality rates were also lower in the continued access cohort (0.9%) compared to the initial premarket approval cohort (2.2%), likely due to a combination of improved patient selection and procedural improvements over time.

"Not only did we meet our prespecified safety and efficacy endpoint, we also saw excellent valve hemodynamics and valve function, and there was a very low rate of leakage across and around the valve," said Raj R. Makkar, MD, FACC, the study's first author. "These findings represent significant progress in overcoming the historical limitations associated with using off-label TAVR devices for aortic regurgitation."

Noting that almost one-quarter of patients required a pacemaker device after their TAVR procedure, the researchers are exploring potential opportunities to modify the procedure or device design to reduce this need. Researchers are also planning a randomized controlled trial to compare TAVR with the Trilogy device vs. open-heart surgery in patients eligible for either procedure.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Echocardiography/Ultrasound

Keywords: ACC Annual Scientific Session, ACC25, Transcatheter Aortic Valve Replacement, Regurgitation, Echocardiography